Hoffman, Amy J. PhD, RN; Brintnall, Ruth Ann PhD, AOCN, APRN-BC; Brown, Jean K. PhD, RN, FAAN; von Eye, Alexander PhD; Jones, Lee W. PhD; Alderink, Gordon PhD, PT; Ritz-Holland, Debbie BSN, RN, OCN; Enter, Mark RN, OCN; Patzelt, Lawrence H. MD; VanOtteren, Glenn M. MD
Fatigue is an unresolved problem for many cancer survivors, and this is particularly true for persons with lung cancer.1,2 Likewise, persons with lung cancer report that 2 of their most prevalent unmet supportive care needs include the inability to self-manage fatigue and attain adequate exercise to preserve independence in activities of daily living.3–5 Lung cancer is one of the most common solid tumors, and it remains one of the most deadly cancers in the world.6 Yet, it remains woefully understudied with little information regarding the early postoperative recovery period for those persons with early-stage non–small cell lung cancer (NSCLC).7 This study focuses on the post–hospital discharge recovery period and describes the incorporation of an intervention designed to meet the immediate known needs of this patient population—fatigue, fatigue self-management, and exercise.
Fatigue is a prevalent, distressing, and unmanaged symptom in persons with cancer.8,9–13 Longitudinal studies of persons with NSCLC after surgery report persistent and/or worsening of fatigue.2,14–18 Research identifies the most frequently unmet supportive care needs as managing fatigue, physical deterioration, performing activities of daily living, and receiving support to exercise.3,4,19 Currently, no guidelines exist for routine rehabilitative support for persons with NSCLC after surgery.2,18,20 Likewise, the optimal exercise program for persons with NSCLC recovering from surgery is not known.21–23 To date, exercise interventions for NSCLC patients after surgery have been facility based, utilizing conventional exercise equipment with moderate- to high-intensity exercise prescriptions.21,24–26 Also, studies have not addressed the critical transition from hospital to home after surgery, leaving patients without a preemptive plan to address symptoms such as cancer-related fatigue (CRF).2 The works of Naylor et al27,28 demonstrate that adults with multiple comorbid conditions and complex treatment plans are vulnerable during the transition from hospital to home. Naylor29 has also demonstrated that designing services during the transition from hospital to home provides healthcare continuity and avoids poor outcomes among high-risk patient groups. Research suggests that light exercise may be a valid alternative to higher-intensity exercise as light exercise may be associated with improved symptoms (CRF), functioning, and quality of life for deconditioned populations with comorbid conditions.30,31
Because CRF is a multiple determined construct,9 research suggests that integrating psychological interventions with physical exercise may be beneficial in ameliorating fatigue.32 To date, there have been no intervention studies dedicated to postsurgical NSCLC patients that have integrated psychological processes combined with light exercise to target CRF. According to Bandura,33(p.411) successful adoption and adherence to exercise even in healthy populations require perceived self-efficacy (PSE), perception of ability. Thus, structuring an environment that can reduce the barriers to exercise is essential for the postsurgical NSCLC population.
The primary goal of this feasibility study was to obtain descriptive information on the feasibility, acceptability, and safety of a home-based exercise intervention administered over the presurgical and postsurgical trajectory of the NSCLC patient. After surgery, the participants were engaged in an innovative 6-week home-based exercise intervention designed to enhance PSE for CRF self-management. This intervention was used to augment the rehabilitation of the postsurgical NSCLC participants. Specifically, we aimed to:
1. Assess feasibility to recruit and retain participants to the study.
2. Analyze participants’ level of adherence to the intervention.
3. Evaluate participants’ level of acceptability for the intervention.
4. Examine changes in study end points including CRF severity; PSE for fatigue self-management, walking, and balance; CRF self-management behaviors (walking and balance exercise); and functional performance (number of steps taken per day).
Principles of the Transitional Care Model29,34 served as the underpinning for the approach to the implementation of the intervention, whereas a tested theoretical framework, the Theory of Symptom Self-management (TSSM),35 guided the design and analysis. Principles from the Transitional Care Model29,34 provide for a continuum of care including presurgical and postsurgical screening and engagement, managing symptoms using education for the promotion of self-management, healthcare team and patient collaboration, continuity of care from hospital to home, and postsurgical coordination of care while maintaining relationships using a transdisciplinary approach. The TSSM35 guided the intervention’s design and analysis providing insight into how a person’s PSE in his/her ability to self-manage symptoms, CRF severity, influences performance of CRF self-management behaviors. Hoffman et al36 demonstrated that targeting CRF severity by enhancing PSE for CRF self-management is important for improving functional status among persons with various types of cancer, including lung cancer. Thus, for this study, we anticipated that an intervention designed to enhance PSE for CRF self-management, walking, and balance exercises will influence CRF self-management behaviors (walking and balance exercises), which will have a positive impact on CRF severity and functional performance (number of steps per day).
This article reports on phase 1 of a 2-phase study. Following the Transitional Care Model, phase 1 of the study was designed to leverage the strengths of our transdisciplinary team to ensure continuity of care to address the critical transition from hospital to home and initiate exercise for 6 weeks through the transition to maintenance of exercise including the critical transition through initiation of chemotherapy and/or radiation therapy as applicable. Upon completion of phase 1, participants were asked if they would like to participate in phase 2 of the study. Phase 2 addressed the maintenance of exercise for an additional 10 weeks including continuance through completion of chemotherapy and/or radiation therapy as applicable.
Sample and Setting
The target sample was derived from 2 participating sites at a university-affiliated teaching hospital within the western Michigan area. A single-arm feasibility study was implemented in late November 2010 after achieving full-board approval from institutional review boards at 2 universities and the recruitment site. With the exception of the recruitment of 1 participant, the initial eligibility criteria and study protocol were found to be too stringent and not feasible (Figure 1). These criteria and protocol were later revised after our transdisciplinary team reviewed the initial screening data and the data of the 1 participant who enrolled and completed the intervention. The refined eligibility criteria and protocol were initiated in May 2011 after obtaining a second set of full-board approvals and resulted in 5 participants being recruited in the first 3 weeks (Figure 2). We met the minimum enrollment objective (n = 5–10) by enrolling 7 participants, which provided diversity for the feasibility sample. Major eligibility criteria are outlined in Table 1. Upon completion of the 6-week intervention (phase 1), participants were given the option to extend their study participation for an additional 10 weeks (phase 2). All 7 participants elected to extend participation for an additional 10 weeks.
A clinical oncology research nurse screened, identified, recruited, and enrolled patients who were expected to undergo surgery for suspected lung cancer. Potential participants were identified during clinic appointments while undergoing diagnostics to confirm a potential diagnosis of NSCLC. Written informed consent was obtained from all participants before initiating any study procedures, followed by collection of presurgery baseline data by trained research staff. Following principles of the Transitional Care Model, a primary registered nurse intervener (nurse) was assigned to each participant for the duration of the study to ensure joint healthcare team–patient collaboration and continuity of care. A preassigned secondary nurse was designated should the primary nurse become ill or unable to meet with the participant. The nurse engaged each participant after presurgery baseline data were collected and provided an overview of the exercise intervention while teaching PSE-enhancing CRF self-management education (prepared participant to self-manage CRF and participate in exercise after discharge from the hospital). The PSE-enhancing CRF self-management education was provided to each participant in the participant’s CRF resource book to be used by the participant throughout the study and included information based on the National Comprehensive Cancer Network Practice Guidelines for Cancer-Related Fatigue.37
The nurse conducted a telephone visit within 3 days after hospital discharge to screen for readiness to start the exercise intervention. To ensure safe exercise participation, participants were deemed ready to start if their usual level of symptom severity in the last 24 hours for key symptoms of pain, nausea, vomiting, and dyspnea was rated less than or equal to 5 on an 11-point scale (0–10, 10 = most severe). If the participant was ready to exercise, the nurse scheduled a home visit to start the exercise intervention within a week of hospital discharge. When a key symptom severity was rated greater than 5, the nurse contacted the participant’s surgeon’s office for recommendations. The nurse would repeat this step each day until the participant was ready to start exercising.
FIRST HOME VISIT
The first home visit included setting up the exercise equipment—the Nintendo Wii Fit Plus—to the participant’s television, teaching the exercise intervention, and reinforcing the CRF self-management education and exercise safety precautions. The nurse followed up the home visit with a phone visit within 24 hours to answer any questions and concerns regarding the exercise intervention.
The nurse scheduled a home visit at the start of week 2 of the exercise intervention and phone visits at the start of weeks 3 to 6 with additional visits available on request of the participant. During these visits, the nurse reviewed the participant’s Daily Diary with the participant and provided PSE-enhancing CRF self-management interventions to support the exercise intervention and adjust the exercise prescription per guidelines. The participant used the Daily Diary to record exercise-related activity and symptoms or problems.
The 6-week exercise intervention designed to enhance PSE for CRF self-management to augment the rehabilitation of postsurgical NSCLC patients was initiated on the first home visit. The intervention was designed to promote regular, light-intensity walking and balance exercise of less than 3.0 metabolic equivalents that corresponds to levels of usual activities of daily living.38 Combining walking with balance exercises has been found to have a positive effect on balance, confidence in walking, and walking speed.39,40 Participants also performed warm-up exercises designed for this patient population. Walking with the Wii throughout this article implies walking in place with the Wii. Walking with the Wii was comfortable and self-paced (eg, participants could stop instantly—unlike a treadmill). The Wii Fit Plus provided a virtual environment where the participant saw themselves, friends, and even their dog walking on a sunny day next to a stream, through a village with happy, familiar faces offering encouragement. As they walked in place in their home, they saw themselves taking a corresponding step in the virtual environment. Duration of walking started at 5 minutes each day for 5 days during week 1 and was anticipated to increase by 5 min/d each week with the goal of walking 30 min/d during week 6. At the start of each week, the nurse assessed the participant’s readiness to advance the walking prescription. The duration was increased 5 minutes each week if the participant’s PSE for attaining that duration was greater than 70% on a 0% to 100% scale, with 100% having high PSE.41 Gradually increasing walking duration promotes achievement of exercise goals building PSE for CRF self-management and walking. Participants performed Wii Fit Plus balance exercises 5 days a week for weeks 1 to 6 selecting from a menu of predetermined Wii balance exercises. Balance exercises used a gaming format and scoring system as motivation to improve performance and included downhill skiing, soccer, golf, and video game activities. Exercises used competitive and engaging formats, keeping users captivated while they were exercising. Exercises provided encouragement that participants could partake in hobbies they may have thought they could never participate in again. Participants wore a pedometer to record their total number of steps per day. Data were recorded in the participant’s Daily Diary.
Inclusion criteria required that participants have phone access while exercising should the participant need assistance. Participants were provided safety criteria prior to the start of each exercise intervention. Participants were taught to maintain a light-intensity dose of exercise by (1) monitoring their heart rate using a heart rate wristwatch to ensure their heart rate was less than or equal to 60% of their heart rate reserve,23 (2) ensuring their perceived level of exertion was less than 3 on a scale of 0 to 10,22,23 and (3) ensuring they could talk and sing while exercising (Talk Test).23,41 Participants documented any symptoms/problems that occurred during the exercise intervention and any action taken in response in their Daily Diary for review by the nurse. The nurse was available by phone and could make a home visit to ensure the safety of the participant. Should participants report unmanaged symptoms (>5 on a scale of 0–10, 10 = most severe) or clinical problems, participants were referred to their healthcare provider, and these referrals were recorded in the nurse intervener log. The nurse intervener log provides a study protocol for weekly participant telephone or home visits and a log to include any participant-reported unmanaged symptoms or clinical problems for which they were referred to their doctor.
Descriptive Variables and Study End Points
Physiological and contextual patient characteristics depict the sample. Physiological patient characteristics included age, race, gender, performance status, comorbid conditions, smoking status, surgical procedure, cancer stage, histological type, length of hospital stay, body mass index (BMI), and adjuvant treatment. Contextual patient characteristics included education level, employment status, marital status, number of children living at home, and income level. Physiological and contextual patient characteristics were collected via demographic questionnaire, medical record chart review, and a modified Comorbidity Questionnaire. Comorbid conditions were assessed using a modified version of the Comorbidity Questionnaire,42 which was used to inquire about the presence of 15 chronic health conditions, with content validity and test-retest reliability having been established. For this study, this variable consisted of the sum of the total number of chronic health conditions identified via the Comorbidity Questionnaire combined with the patient report of other comorbid conditions as confirmed in the medical record. Smoking status (never, former, current) was determined through responses to questions based on the Behavioral Risk Factor Survey regarding tobacco history and current smoking status.43,44 The Karnofsky Performance Status (KPS) was used as an objective appraisal of physical functioning and a psychometrically sound proxy for health status and quality of life.45 The KPS is commonly used in oncology and is scored from 0%, meaning dead, to 100%, meaning no complaints, no special care needs with no evidence of disease. A score of 50% indicates a person needs considerable assistance and frequent medical care. Feasibility was determined by analyzing rates of recruitment, adherence, retention, and monitoring for adverse events. An Acceptability Questionnaire was conducted at the end of week 6 (postintervention). Four questionnaires were used to measure change in study end points including the Brief Fatigue Inventory (BFI), Perceived Self-efficacy for Fatigue Self-management (PSEFSM) Instrument, the Self-efficacy for Walking Duration Instrument, and the Activities-Specific Balance Confidence Scale. The Daily Diary provided the participant with the means to record CRF self-management behaviors (walking and balance exercise) during the exercise intervention and functional performance (number of pedometer steps each day). Collection of end-point data excluding the Acceptability Questionnaire was performed by trained research staff in person for presurgery and via telephone for postsurgery prior to the start of the intervention and at the end of weeks 1 through 6, with corresponding Cronbach’s α’s presented in Tables 3 and 4. The Acceptability Questionnaire was mailed to participants by research staff at the conclusion of the research study. Participants completed their questionnaire at their leisure in their home and mailed them back to research staff when completed.
Feasibility was determined by analyzing the recruitment rate, which was measured as the percentage of eligible patients who were recruited who consented. Adherence was measured as the percentage of those participating in the intervention that adhered to the intervention. Weekly adherence was calculated by taking the number of times the prescribed intervention was completed divided by the number of interventions prescribed for the week. Retention was measured as the percentage of those enrolled that completed the program from the first phone visit after surgery to the final data collection at week 6. Adverse events were to be recorded in the Daily Diary and monitored by the nurse and principal investigator. Likewise, any unmanaged symptoms or clinical problems requiring physician referral were recorded by the nurse in the nurse intervener log and monitored by the principal investigator. Our goal to show feasibility was to be able to recruit 50% of eligible participants and show adherence and retention to the intervention at a rate of 70% with minimal adverse effects. These goals were based on the NSCLC exercise study results from the work conducted by Jones et al46,47 and the home-based exercise study results from the study of Mock et al.48
Acceptability assessment for this study was similar to those used in other exercise studies.49,50 The research team developed a questionnaire for the participants with a Flesch-Kincaid reading grade level of 6. Participants rated their degree of satisfaction with the exercise intervention for 15 items on a 6-point Likert scale from strongly disagree to strongly agree. An average positive acceptability score of 4 (1–6; 6 = agrees strongly) was set as the minimum level to achieve to indicate the intervention was acceptable.
The BFI is a 9-item measure of CRF severity and its impact on daily functioning. On an 11-point scale (0–10, 10 = most severe), 3 items measure fatigue severity (now, usual, and worst fatigue), and 6 items measure the impact of fatigue on daily functioning in the past 24 hours. Substantial evidence supports the psychometrics of the BFI in the cancer population, with Cronbach’s α ranging from .82 to .97.51,52
Perceived Self-efficacy for Fatigue Self-management Instrument contains 6 items measuring on an 11-point scale (0–10, 10 = very certain) confidence in performing fatigue self-management behaviors. Content and construct validity through mediation analyses and structural modeling demonstrated sound psychometrics in persons with cancer diagnoses, with a reported Cronbach’s α of .92 for persons with cancer including lung cancer.53
Perceived Self-efficacy for Walking Duration Instrument measures a person’s confidence to complete incremental 5-minute periods of light-intensity pace walking (5–30 minutes) on an 11-point scale (0%–100%, 100% = highly confident). Internal consistency reliability reported for a sedentary, older sample with comorbid conditions including cancer for pre-exercise and postexercise was a Cronbach’s α greater than .95.54
Activities-Specific Balance Confidence Scale is a 16-item scale measuring confidence for balance during specific everyday physical activities. On an 11-point scale (0%–100%, 100% = most confident), higher scores indicate greater balance confidence during physical activities such as walking in and outside the home. The scale has demonstrated sound psychometrics tested in diverse populations of older adults living at home or in retirement communities with test-retest reliability over a 2-week period, high internal consistency with Cronbach’s α ranging from .82 to .90, convergent and discriminant validity, and the ability to discriminate between fallers and nonfallers and low-versus high-mobility groups.55–57
The Daily Diary is a weekly diary that provides the participant with a structured format using a tabular design for which they can enter their weekly exercise prescription (provided by the nurse during the weekly home or phone visit) as well as their daily exercise performance. The Daily Diary provides the participant a means to capture CRF self-management behaviors such as the daily number of minutes walked and number and type of balance exercises performed. The participant also records the number of steps taken each day in the Daily Diary as indicated by the Sportsline Step and Distance Pedometer. Except for riding a bike and swimming, pedometer readings have been found to be valid and reliable measures of functional performance.58,59 Participants wore the pedometer every day for 6 weeks of the study except during Nintendo Wii exercise so that nonintervention performance levels could be assessed.
All analyses were conducted with IBM SPSS Statistics version 19.0. Descriptive statistics were calculated to estimate the frequencies, means, and SDs of the study variables. Next, the pattern of change in CRF severity; PSE for fatigue self-management, walking, and balance; CRF self-management walking and balance exercise behaviors; and the number of pedometer steps per day per week were longitudinally displayed. Results were depicted at baseline presurgery and postsurgery prior to the start of the intervention and at the end of each week of the 6-week intervention.
Participant characteristics (n = 7) are displayed in Table 2. The mean age was 64.6 years (range, 53–73 years); most were women, employed, and with no children living at home. The participants had a diverse educational background from completing high school to completing a college education. Likewise, participants reported annual household incomes ranging from $15 000 to $19 999 to more than $100 000 per year. Prior to surgery, participants were found to be assessed in 1 of 2 categories of the KPS Scale: 70%, meaning able to care for self but unable to carry on normal activity and do active work, and 90%, meaning having minor signs and symptoms of disease. All participants reported tobacco usage, with 5 participants using tobacco up to diagnosis and all reporting no tobacco usage after learning they required surgery for suspected NSCLC through 1 month after surgery. The mean number of comorbid conditions per participant was 5.9, ranging from 2 to 12 comorbid conditions per participant. The most common comorbid conditions requiring active treatment included osteoarthritis (n = 5), hypertension (n = 4), hyperlipidemia (n = 4), and chronic obstructive pulmonary disease (n = 2). The BMI (in kg/m2) for participants before surgery and after surgery at the first home visit indicated that 1 participant had a normal BMI (18.5–24.9 kg/m2), 5 participants were overweight (25–29.9 kg/m2), and 1 participant was obese (>30 kg/m2). One month after the first home visit postsurgery, one participant moved from the obese BMI category to the overweight BMI category, and 2 participants moved from the overweight BMI category to the normal BMI category, leaving a total of 3 participants in the normal BMI category and 4 participants in the overweight BMI category. Participants all underwent lobectomy and were found to have either adenocarcinoma (71.4%) or squamous carcinoma (28.6%) NSCLC, whereas stage of diagnosis varied from stage IA through stage IIIA. The mean hospital stay was 7.8 days, with a range of 5 to 12 days. Overall, 5 patients experienced commonly reported complications prior to discharge from the hospital consisting of atrial arrhythmia (28.6%), atelectasis (14.3%), hemorrhage requiring surgical correction (14.3%), and hypotension (14.3%).
The mean time between the symptom screening and the first home visit to initiate the exercise intervention for all participants was 32.3 hours (range, 5–54 hours). Five participants started chemotherapy on average of 42.4 days after surgery. For those who underwent chemotherapy, the chemotherapy treatment was initiated at a mean time of 5.2 weeks after the start of the intervention. As seen in Table 2, all chemotherapy protocols used 2 drugs, one of which was a platinum compound. In combination with chemotherapy, 1 participant received radiation treatments 5 days a week for stage IIIA NSCLC.
Study Aim 1: Feasibility to Recruit and Retain Participants
The study flow is presented in Figures 1 and 2. Figure 1 depicts the initiation of the study on November 16, 2010, under a study protocol with stringent eligibility criteria through May 30, 2011. Figure 2 depicts the revised, modified study protocol, and eligibility criteria starting May 31, 2011, through September 15, 2011, incorporating lessons learned during the first part of the study. In brief, 5 participants were approached, and 1 participant consented, completing the entire intervention using the stringent study protocol and eligibility criteria. Following the revised study protocol and eligibility criteria, 8 patients consented, with 2 deemed ineligible from the study and the remaining 6 patients completing the entire intervention. Feasibility to recruit based on the revised study protocol and eligibility criteria resulted in 8 of 10 participants (80%) who were approached and consented, exceeding our goal of 50%. All 7 patients enrolled in the study completed the 6-week exercise intervention for 100% retention, exceeding our goal of 70%.
Study Aim 2: Participant’s Level of Adherence to the Intervention
The mean adherence rate for the entire exercise intervention was 96.6% (SD, 3.4%) (range, 90–100%), which included both walking and balance exercise adherence levels (exceeding our goal of 70%). Participants did not report any exercise-related problems or symptoms during or after their exercise sessions. However, all 7 participants reported unmanaged symptoms at some point in the study during the nurse home or phone visits that resulted in the nurse advising the participant to contact his/her physician. In each case, these symptoms were deemed not related to the exercise intervention.
Study Aim 3: Participant’s Level of Acceptability to the Intervention
Participants agreed strongly to a high level of satisfaction with the exercise intervention, giving it a mean score of 5.8 of 6 (SD, 0.18) (range, 5.6–6, with 6 meaning agreed strongly), exceeding our goal of 4 of 6. All participants strongly agreed that exercising at home was convenient, the nurse interaction from the telephone calls were helpful, that they would recommend the program for someone like themselves after having surgery for lung cancer, and overall, that the program helped to build their confidence to manage fatigue. Moreover, the majority agreed strongly that the CRF resource book was useful, exercising at home was convenient, the Wii walking and balance program was enjoyable and easy to use, having a wristwatch and perceived exertion scale to monitor heart rate was helpful, the Daily Diary to record progress was easy to use, and overall, the participants found that they improved each time they used the Wii to exercise. Two participants recommended that toward the end of the 6-week program (when strength had improved while walking for longer periods) other walking activities be introduced to prevent boredom from exercise. Likewise, participants commented that in-home walking activities are important to have available when undergoing chemotherapy and on hot, humid, and cold days that flare allergies and asthma. Also, when asked if they would like to extend participation to phase 2 of the study, all 7 participants elected to continue to participate for the additional 10 weeks.
Study Aim 4: Examination of Change in Study End Points
As shown in Table 3, the mean CRF severity scores before surgery for NSCLC began at 3.3 (SD, 1.7) and increased to a mean CRF severity score of 4.8 (SD, 2.9) after surgery prior to the start of the exercise intervention. However, mean CRF severity scores showed a pattern of decline from postsurgery baseline through the end of week 4 (mean, 2.4 [SD, 1.9]) of the exercise intervention. A subtle increase in the mean CRF severity score at the end of weeks 5 (mean, 2.5 [SD, 1.7]) and 6 (mean, 2.8 [SD, 2.8]) occurred when chemotherapy began on average 4.8 weeks after the start of the exercise intervention for 4 of 7 participants. All participants stated that the exercise intervention helped them manage their fatigue, with 1 participant stating “It gave me a lot of strength so I could keep going.” Another participant stated, “I really believe that it helped me very much. I don’t believe I would have gotten the same result without it.” A third participant stated “I would recommend the program to everyone.”
PERCEIVED SELF-EFFICACY FOR FATIGUE SELF-MANAGEMENT
As shown in Table 3, at both presurgery and postsurgery baseline, the mean PSEFSM score was 7, indicating an acceptable level of ability to manage fatigue. However, at postsurgery baseline, the SD increased from 1.5 to 2.2, showing an increased range in scores over presurgery baseline. The mean PSEFSM score declined after week 1 of the intervention and continued to decline to a mean score of 5.4 (SD, 2.3) after week 2. This decline in PSEFSM corresponded to increasing mean CRF scores of 4.0 to 4.3 from week 1 to week 2. However, after week 3, the mean CRF score decreased from 4.3 to 3.7, whereas PSEFSM had its most significant increase in mean PSEFSM from 5.4 to 7.7. As CRF continued to improve in week 4 to a low of 2.4, PSEFSM reached its highest level with a mean of 8.8. As some participants began chemotherapy over weeks 5 and 6, PSEFSM decreased from 8.8 to 8.3 as CRF increased from a mean of 2.5 to 2.8. Note that all PSEFSM levels exceeded presurgical levels from weeks 3 through 6.
PERCEIVED SELF-EFFICACY FOR WALKING DURATION
As shown in Table 4, the mean PSE for walking 30 minutes at presurgery baseline was 96.4% (SD, 6.1%) and dropped more than 50% to a postsurgery mean of 47.4% (SD, 22.6%) prior to the start of the intervention. With each week of the intervention, the mean score for walking 30 minutes continued to build until it nearly achieved presurgery levels at week 6 with a mean of 93.3% (SD, 10.9%), with all participants reporting acceptable confidence levels (≥70%) to walk 30 minutes at a light intensity without stopping, with 5 of 7 reporting a greater than 90% confidence level.
PERCEIVED SELF-EFFICACY FOR BALANCE
As depicted in Table 4, similar to the participant’s PSE for walking 30 minutes, the participant’s mean level of balance confidence decreased from a presurgery mean of 86.0% (SD, 18.6%) to a postsurgery mean of 72.8% (SD, 20.5%) prior to the start of the intervention. The participant’s mean PSE for balance score returned to near presurgery levels, with a mean of 84% (SD, 18.2%) by week 3 and remaining stable to week 6 with a mean of 83.7% (SD, 24.8%).
CANCER-RELATED FATIGUE SELF-MANAGEMENT BEHAVIOR VIA WALKING AND BALANCE EXERCISE
As shown in Table 5, the mean minimum prescription for walking increased, with all participants walking 5 min/d, 5 days a week for the first week, and incrementally increasing to 25 (SD, 4.0) min/d (range, 20–30 min/d). Participants exceeded the minimum walking prescription with a mean walking time of 5.3 (SD, 0.48) min/d (range, 5–6.3 min/d) during the first week of exercise and increased walking time to 26.1 (SD, 4.6 min/d; range 20–31.2 min/d) during the last week of the exercise intervention. Participants’ mean minimum number of prescribed balance exercises per day was set at 3 initially and remained relatively constant through the 6-week intervention. Participants exceeded the minimum number of prescribed balance exercises per day, averaging 4 balance exercises per day throughout the study.
The mean level of steps taken per day increased from week 1 (mean, 4650 [SD, 3105] steps) through week 6 (mean, 6393 [SD, 3752] steps) (Table 6).
The results of this feasibility study demonstrate that a home-based, light-intensity walking and balance exercise intervention for patients immediately following discharge from the hospital after surgery for NSCLC is feasible, safe, well tolerated, and highly acceptable. Likewise, the results indicated that the intervention positively impacted end points such as CRF severity; PSE for fatigue self-management, walking, and balance; CRF self-management behaviors (walking and balance exercise); and functional performance (number of steps taken per day). Relative to functional performance, there was some speculation that the number of steps taken each day by study participants may decrease with increased intervention walking durations. That was not the case in this feasibility study as participants increased their daily walking activity at the same time they were increasing their intervention walking duration. This is consistent with the expectation that increased functional capacity through exercise would increase functional performance.60 Likewise, there was speculation that the initiation of adjuvant chemotherapy and/or radiation therapy would trigger the cessation from the exercise intervention. However, this was not the case as participants continued the exercise intervention. Likewise, the question of whether participants would continue to want to exercise after phase 1 was answered as all 7 participants elected to participate in phase 2 of the study, which extended the intervention an additional 10 weeks. Also, because CRF is one of the most frequently reported and distressing symptoms for persons with NSCLC, the findings that PSEFSM and CRF severity improved to levels better than presurgical levels with the incorporation of a safe, well-tolerated and highly acceptable PSEFSM-enhancing intervention are promising. Moreover, being able to provide an intervention to a highly vulnerable population (postsurgical NSCLC participants) within days of discharge from the hospital could provide a means for rehabilitation that does not currently exist.
To date, postsurgical exercise interventions for the cancer population have been initiated much later in the recovery period; consisted of moderate to vigorous intensity; were longer in duration (>10 weeks); were structured, inpatient or facility based; and have not incorporated transitional plans from hospital to home to address fatigue.21,24–26 The literature indicates that adoption of exercise even in healthy populations is difficult and requires PSE to engage in exercise.33 Consequently, this exercise intervention was designed mindful of the challenges that both healthy persons and those recovering from NSCLC surgery would face in an effort to enhance PSE for CRF self-management to augment their rehabilitation. Thus, the exercise intervention in this study was designed to span 6 weeks starting promptly after hospital discharge extending to a critical juncture where patients may transition to initiation of adjuvant therapy (eg, chemotherapy, radiation therapy) and/or can increase to more demanding physical activity levels (eg, greater lifting, pushing, pulling). In addition, the exercise intervention was initiated promptly after discharge from the hospital, knowing that CRF can be induced by many factors including becoming less active, which knowingly occurs when a person is hospitalized after undergoing surgery for NSCLC. Our pressing rehabilitation concern was driven by the follow-up results of the renowned Dallas Bedrest and Training Study conducted in 1966.61 In the follow-up study conducted by McGuire et al,62 the short-term effects of 3 weeks of bed rest in 5 healthy young men at age 20 years in 1966 were found to be more profound than 30 years of aging, highlighting the deleterious effects that inactivity can have on a patient. In this current study, with participants having a mean hospital stay of 7.8 days, the immediacy of the intervention for NSCLC patients is deemed critical. Also, to promote the initiation of exercise for participants after surgery, we used a light-intensity, less-than-3.0 metabolic equivalents, rather than a moderate- to vigorous-intensity walking and balance exercise, which corresponds to usual activities of daily living.38 The American College of Sports Medicine,23,63 the American Heart Association,64 and the American Cancer Society22 recommend that persons who are sedentary, deconditioned, recovering from surgery, and with multiple comorbid conditions first focus on developing a habit of regular exercise including walking in order to complete usual activities of daily living. Likewise, balance exercises were combined with walking because balance exercises when combined with walking have been found to have a positive effect on balance as well as walking confidence and speed.
Strengths and Limitations
This single-arm feasibility study was intentionally planned with a sample size of 5 to 10 participants. To the best of our knowledge, this was the first home-based exercise intervention conducted immediately following discharge from the hospital after surgery for NSCLC, which includes patients transitioning to adjunct treatment with chemotherapy alone or combined with radiation therapy. However, this study does have limitations, including the small sample size and the nonrandomized controlled design. Consequently, observed changes in study end points may be explained by the natural course of postoperative recovery. Also, no biochemical verification was used to confirm self-report of smoking status. The study was bounded by time with baseline assessment occurring before and after surgery prior to the intervention with the addition of a symptom assessment screen to ensure all participants were safe to initiate the intervention with key symptoms (pain, nausea, vomiting, and dyspnea) at a similar level of symptom severity. In addition, collecting data on key variables on a daily and weekly basis tightened the ability to observe changes that occurred over time. The study provided variation in participant ages, income, and education levels and included both men and women. Participants had a range of performance status scores prior to surgery and an array of comorbid conditions from a minimum of 2 to a high of 12. All participants were white, with the exception of 1 minority candidate who was successfully recruited but subsequently deemed ineligible because of exacerbation of an existing comorbid condition at baseline assessment. The sample included participants with each stage of NSCLC from IA through IIIA with varied histology. Although the study provided for the inclusion of varied types of surgical procedures, all patients underwent a lobectomy. Postsurgical treatment trajectories varied, with some participants requiring no further treatment, some requiring chemotherapy, and one other requiring both chemotherapy and radiation. In addition, the study was conducted in 2 participating sites within a single organization as the tertiary care center.
To date, postsurgical NSCLC patients with multiple comorbid conditions have been left with no standard rehabilitation options. The findings from this home-based exercise intervention feasibility study indicate that it is not only feasible and safe for these very sick patients to exercise immediately upon discharge from the hospital, but it is also acceptable to the patients, and they will adhere to the exercise for up to 6 weeks even through the initiation of adjuvant chemotherapy and/or radiation therapy. Likewise, when given the option, all participants opted to extend the intervention for an additional 10 weeks, indicating their enthusiasm for the intervention. As such, postsurgical NSCLC patients can be equipped with a light-intensity, self-paced walking and balance program that may have a long-lasting impact on the reduction of CRF and the prevention of further development of CRF. Having an intervention that is readily available in the home and can be implemented within days of returning home from the hospital provides patients with empowerment that they can do something to directly impact the quality of their health. The intervention’s utilization of a nurse to assess the participant’s readiness to start exercise and assist the participant in addressing his/her symptoms (should they preclude the participant from initiating exercise) is critical to the success of the intervention. Participants within this feasibility study reported a feeling of being alone and sad after returning home, and the nurse was able to fill this void and provide a continuum of care to help initiate the intervention and to provide support (eg, advise participant to call physician) if any symptoms or clinical problems were unmanaged. The nurse’s weekly calls providing self-efficacy–enhancing support to the participant also proved valuable for participants not knowing what to expect relative to their symptoms and their exercise progress. Because NSCLC participants are among the most vulnerable and may be further compromised by comorbidities, should this intervention prove efficacious, it could also be generalizable across similar vulnerable populations that currently have few or no rehabilitation options. Moreover, a home-based program with a light-intensity exercise program during the initial weeks upon discharge from the hospital is practical because the intensity of the program falls within their current prescribed physical activity level. Likewise, participants within this feasibility study continued the home-based program through the initiation of their adjuvant chemotherapy and/or radiation therapy without any issues as the intensity of the program continued to fall within their prescribed physical activity level. Additionally, patients report that traveling outside the home is often physically challenging and wrought with difficulty in finding someone to assist in helping them to make appointments. Last, further research should focus on a 2-arm study comparing the effects of this exercise intervention to a usual care group with a larger sample size. This feasibility study was valuable in progressing toward this goal by allowing our team to assess the key processes, procedures, resources, and research information (eg, that performance status was more critical than stage of cancer when assessing for readiness to start the exercise intervention) relative to the specific aims.
This feasibility study provided our team with significant insight into whether a home-based exercise intervention would be feasible for a very vulnerable postsurgical NSCLC population. First, understanding and adjusting the eligibility criteria were significant in meeting our recruiting goals, which can be leveraged when applied to a larger randomized controlled trial (RCT). Next, learning that the intervention was highly acceptable and safe and that participants adhered to the exercise intervention through surgical recovery and subsequent initiation of chemotherapy and/or radiation therapy provides important data to justify that this intervention may be feasible, safe, and acceptable when applied to a larger RCT population. Likewise, knowing that upon conclusion of this study all 7 participants volunteered to continue with phase 2 of the study and extend for another 10 weeks was a strong endorsement of the value the participants believed they received from the intervention and its subsequent impact on study end points including their fatigue. The participants’ commitment to participate for an additional 10 weeks provides further data justifying that this intervention study is worthy of extension to a larger RCT population. The success of this feasibility study can be attributed to its basis in theory.
The synthesized theoretical framework was useful to guide our team through the details necessary to address the complex patient needs inherent in persons with NSCLC after thoracotomy. In particular, this patient population is susceptible to breakdowns during the critical transition when discharged from the hospital to home. Following principles of the Transitional Care Model provided an approach that facilitated the implementation of an empowering exercise intervention to promote CRF self-management immediately after discharge to expedite the rehabilitation of an already debilitated population. The TSSM provided a unique framework indicating that a person’s perception of ability to implement behaviors to manage difficult symptoms such as CRF can have a positive impact on the difficult symptom and functional performance. As found in this study, a trend was demonstrated—the stronger the participants believed that they could manage their CRF and implement walking and balance exercises, the greater the improvement in CRF severity, and the greater the implementation of exercise and increase in steps per day (functional performance). Consequently, equipping people to believe that they can exercise under taxing circumstances such as the immediate postthoracotomy recovery period in the NSCLC population is a pivotal step leading to the self-management of symptoms such as CRF. In essence, this study shows preliminary evidence that when participants believed they could address their CRF severity, they implemented the CRF self-management behaviors (walking and balance exercise) and persevered (as shown over time) in implementing these behaviors to reduce CRF severity. As a result, this feasibility study met each of its aims, indicating that the intervention was feasible, safe, and acceptable and showed positive changes in study end points, providing data justifying its extension to a larger RCT study population for further evaluation.
The authors express appreciation for the expertise and support in this effort from the following residing in the Grand Rapids, Michigan, area: the Office of West Michigan Cardiothoracic Surgeons, the Pulmonary Rehabilitation Department and cardiothoracic discharge nurses at Spectrum Health, and the Lung Multispecialty Team at Lemmen-Holton Cancer Pavilion at Spectrum Health.
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