Ream, Emma MSc, BSc(Hons), RN; Richardson, Alison PhD, MSc, BN(Hons), RN, PGDE, RNT; Alexander-Dann, Caroline BSc(Hons), MSc, RN
The symptoms associated with cancer are many and varied. They can occur alone or more generally with each other and have the potential to diminish patients’ quality of life substantially. It is imperative that individuals’ quality of life, perceived by Ferrell et al 1 as the net effect of physical, psychologic, social, and spiritual well-being, is optimized. Multimodality treatments, which combine surgery, radiotherapy, and chemotherapy, have improved the prognosis for many patients with cancer, 2 but these treatments are not without cost. They frequently induce disagreeable side effects, including fatigue. If treatment side effects are severe and the resulting quality of life sufficiently poor, any perceived benefits of increased survival may be negated by these costs.
It is now recognized that patients with cancer frequently become fatigued when undergoing treatment, notably chemotherapy. Fatigue can prove difficult to manage and can affect every area of life. The purpose of this pilot study was to develop and test a nursing intervention that incorporates a range of potentially beneficial strategies to facilitate management of fatigue in adult patients receiving chemotherapy. As a result of this study, the intervention process will be refined for use in a larger clinical trial.
Fatigue associated with illness has been defined as “a subjective, unpleasant symptom which incorporates total body feelings ranging from tiredness to exhaustion creating an unrelenting overall condition which interferes with individuals’ ability to function.”3(p527) Prevalence estimates for cancer-related fatigue range from 60% to 100% and vary according to tumor site, stage of disease, and treatment that is administered. In patients undergoing chemotherapy, prevalence estimates range from 65% to 100%. 4–9
During the last 5 years, patients’ experiences of cancer-related fatigue have become accessible to healthcare providers through the publication of a number of qualitative studies that investigated patients’ perceptions of living with this symptom. These studies have described cancer-related fatigue as a phenomenon that makes one feel “tired to the bone,”1(p1539) as though fatigue strikes at the core of a person, making his or her limbs ache and leading to feelings of exhaustion likened to those encountered when completing a race. 10 These feelings affect functioning and have profound implications for all types of activity, from working outside the home 11 to “accomplishing even the smallest task”1(p1,543) The psychologic implications of these imposed limitations are individual but can be far reaching. Patients frequently talk about the upsetting emotions aroused through feeling useless 1,12 and reliant on others because of the severity of fatigue. 10 These cognitions can arouse feelings of fear, frustration, and depression. 1,13 These qualitative studies also describe the effect of fatigue on social well-being. Relationships with others are easily compromised with the effort required to socialize with others. 1,11 The all-encompassing nature of fatigue has a profound effect on quality of life, and it is no surprise that patients perceive fatigue as one of the most troublesome and distressing symptoms associated with cancer and its treatment.
Despite this, the limited research concerning health professionals’ management of fatigue depicts nurses and doctors infrequently advising patients about methods for its relief. 14,15 Furthermore, it appears that patients seldom try to alleviate it. 16 When patients take action they base their attempts on common sense. They repeatedly employ activities that are principally sedentary, including resting and sleeping, which generally provide little relief. 13,16 This suggests that patients require education and guidance from healthcare professionals to select more innovative and effective fatigue-relieving strategies.
Evidence from previous studies has identified the potential value of a range of different strategies for the relief of fatigue. Exercise, 17–23 scheduled participation in distracting activities, 24,25 psychological interventions, 26–29 and education about fatigue 30 have proved beneficial for patients with cancer who are experiencing fatigue. These techniques have been critiqued in a recent and more detailed overview of the literature. 31 Undoubtedly, patient education is critical in the process of managing fatigue because it can influence the approaches individuals take for its relief.
Beating Fatigue Nursing Intervention
The nursing intervention, referred to as Beating Fatigue, comprised 4 principle components: assessing/monitoring fatigue, education on fatigue, coaching in self-care, and provision of emotional support. It aimed to educate patients who are to receive chemotherapy about fatigue and to aid their coping with it. It was planned to enable patients to lead as full and satisfying a life as possible during treatment with chemotherapy despite the presence of fatigue. Through adopting a multifaceted intervention, it was envisioned that education and emotional support would be tailored to individual need and generate an intervention that individuals found acceptable and beneficial.
The intervention was delivered to patients during 3 successive cycles of chemotherapy, beginning on the day when the first cycle of treatment was administered. It was provided during 3 cycles rather than an entire course of treatment because patients discontinue treatment after 3 cycles if their response to treatment is poor. To ensure the intervention was consistent for all participants it was delivered during 3 cycles.
An investigator-designed information pack was provided to patients before chemotherapy. Its aim was to explain feelings of fatigue and prepare patients for what is essentially a normal symptom during chemotherapy. The pack comprised sets of loose-leaf sections outlining self-care strategies that aid the management of fatigue in this patient group. It incorporated information on exercising, balancing activity with rest, prioritizing and delegating activities, dietary supplements, relaxation, diversion, and sleep-enhancement techniques.
Detailed assessment of fatigue and its effect on patients’ lives, was facilitated by a fatigue diary. The fatigue diary, designed for this study, was completed by patients for the first 7 days of each of the 3 treatment cycles during which Beating Fatigue ran. This week-long period was selected because fatigue generally peaks during this phase of the treatment cycle. The therapeutic effects of recording side effects, including fatigue, in a daily diary have been identified. 8 For this study, it was perceived that a fatigue diary would enable patients to recognize periods during their treatment when they were susceptible to fatigue and facilitate their insight into aggravating and relieving factors.
Diary entries were reviewed by a support nurse who visited patients at home once during each treatment cycle. She assessed and discussed the extent to which fatigue impeded patients’ lives and reviewed the efficacy of self-care they adopted in attempt to relieve it. Strategies promoted in the Beating Fatigue information pack were reviewed in these meetings, and the support nurse coached patients in their use. Furthermore, these meetings allowed patients to explore the meaning of fatigue for their lives, hopes, and future goals. A meeting schedule was developed to guide the domiciliary meetings and enhance their standardization.
The support nurse in this study was an experienced cancer nurse with a counseling qualification and knowledge of cancer-related fatigue. The essential elements of the Beating Fatigue intervention are presented in Table 1.
Design and Conduct of the Pilot Study
The pilot study was conducted to:
* Test the feasibility of the Beating Fatigue program
* Examine patients’ responses to a multifaceted nursing intervention for cancer-related fatigue
* Refine the elements of the intervention to maximize treatment effect
A longitudinal design was used in this study. Patients took part in the study and its evaluation during a 4-month period. Ten consecutive patients scheduled to begin chemotherapy for treatment of cancer within the following anatomical areas: lower gastrointestinal (GI), mid-GI, upper GI, pancreatic, respiratory, lymphoma, and breast, were invited to participate in the study. Eligible patients had to be aged at least 18 years and able to read and write English. Patients with a current diagnosis of depression were excluded from the study along with those, at the discretion of clinical staff, who were unable physically or emotionally to participate in the study.
Subjects were recruited to and consented to participate in the project by the researcher. After receiving instructions on completing the instruments and the design of the study, participants were given the general preparatory information on the manifestation and pattern of fatigue after chemotherapy and general information on its management. Subjects were subsequently seen at home by the support nurse who provided more leaflets on the management of fatigue, from a menu of information, according to patient need and preference.
Outcomes of the Beating Fatigue program were assessed utilizing the Fatigue Diary, 32 the Hospital Anxiety and Depression (HAD) Scale, 33 the SF-36 Health Survey, 34 the Brief COPE questionnaire, 35 and an investigator-designed satisfaction interview schedule. Outcomes other than level of fatigue were measured because it was perceived likely that the intervention would affect other areas of well-being.
A health diary provides repeated measures of selected variables, and when completed daily can provide detailed data on changes in a patient’s condition that may be forgotten later. The Fatigue Diary for this study contained four 100-mm visual analog scales (VASs), which measured the extent of fatigue, the distress fatigue evoked, the effect of fatigue on work and chores, and the effect of fatigue on hobbies and favorite activities. These dimensions of fatigue were measured to reflect the multidimensional nature of fatigue and enable assessment of the intensity, affective, and behavioral dimensions—dimensions that the intervention was designed to affect. VASs have successfully been used to measure cancer-related fatigue and are a sensitive and valid method for measuring this subjective symptom. 8,36
The HAD Scale is brief, is acceptable to patients, and possesses good reliability and validity. 33 Previous testing identified that its anxiety and depression subscales correlate highly with psychiatric assessments and with other instruments measuring these psychologic states. 37 Inter-item correlations for the anxiety and depression subscales reportedly range from 0.41 to 0.76 and 0.30 to 0.60, respectively.
The SF-36 survey provides a useful measure of perceived general health. The factor structure of the instrument has been confirmed by factor analysis, 34 and Cronbach’s alpha coefficients for the different subscales within it are high ranging from 0.73 to 0.90. 38,39 Comparison of scores with other instruments, including the Nottingham Health Profile, has determined its convergent validity.
The brief COPE is a multidimensional coping inventory that was developed to assess the different ways individuals respond to stress. 40 Although limited psychometric testing has been performed on this instrument, preliminary evaluations have been favorable, 40 and it appears that this instrument may provide a valuable instrument in future.
Participants took part in an investigator-designed satisfaction interview at the end of the study. This enabled determination of their perceptions of the helpfulness of the different elements of the Beating Fatigue program. Patients responded to the questions verbally by reporting a value between 1 and 4 where 1 represented the most favorable response and 4 the least. Furthermore, subjects were asked to comment on aspects of the program that they perceived as the most and least useful.
Data Collection Process
The Fatigue Diary was completed for the initial week of patients’ first 3 cycles of chemotherapy. The HAD Scale, SF-36, and Brief COPE were bound into a questionnaire battery and completed by patients before their first cycle to provide baseline data and before their subsequent 3 treatment cycles.
Fatigue was the primary variable and was examined more closely than the other outcome variables. The diary data were aggregated to depict the typical level and pattern of fatigue experienced by participating individuals during the initial week of their first 3 treatment cycles. This statistical manipulation involved calculating the daily mean fatigue score for each patient. This mean fatigue score is an average, or global score, derived from the 4 dimensions of fatigue that were measured each day. The changes in this variable were plotted over time and differences over the courses evaluated by nonparametric analysis utilizing the Kruskall-Walls test statistic. The other outcome variables were subject to pretest post-test comparison through testing with the Wilcoxon matched-pairs signed-ranks test.
Ten patients were recruited to the study, but 2 later withdrew. Thus the sample comprised 8 individuals, the majority of whom were women (Table 2). This reflected the predominance of chemotherapy treatment that was being administered to patients with breast cancer (n = 5) when the pilot study was conducted. Participants had a mean age of 54 years (SD = 10.7, range 33-65). The majority of the sample had been diagnosed within the previous 3 months (n = 5), although 3 of the subjects had recurrent disease that had initially been diagnosed a year previously.
Seven complete sets of diary data were available for analysis. Individuals’ daily mean fatigue scores were calculated and then aggregated into an average daily score for the entire pilot population. This was then plotted for the week after each of the 3 cycles of treatment (Figure 1).
Figure 1 shows that the pilot subjects experienced significantly higher fatigue, on average, at the beginning of cycles 2 and 3 than they experienced for the week after their initial chemotherapy cycle. This was confirmed by the Kruskall-Wallis test statistic (H = 7.5, 2 df, P = < .05). The median value for fatigue during cycle one was 23.8 (mean rank 59.3) as opposed to 38.3 (mean rank 81.0) and 37.8 (mean rank 77.3) for courses 2 and 3, respectively. This is consistent with other reports suggesting that fatigue increases as treatment progresses. 41
Anxiety and Depression Ratings
Seven complete sets of HAD, SF-36, and COPE data were available for analysis. The HAD scale data were analyzed to describe differences in pretest and post-test scores on the anxiety and depression subscales. Results of these comparisons suggest that the intervention affected depression, with all except one of the sample reporting falls in depression from pretest to post-test (Table 3). Wilcoxon matched-pairs signed-ranks test confirmed the significance of this difference (z = − 2.1974, P = .05). There was no such visible improvement in reported anxiety.
General Health Status Ratings
The SF-36 subscales were examined to determine pretest to post-test changes. There appeared to be no consistent changes in these data. Some subscales indicated improvement with time, including the bodily pain subscale, whereas others, including vitality, suggest, if anything, a decline with time (Table 4). None of the changes was significant.
The Brief COPE was not completed well by subjects in this pilot study. Predominantly, subjects omitted items on the final page, which they inadvertently failed to turn over. When items are omitted, they cannot be substituted with this scale. Hence, there were relatively more missing data with this instrument, which rendered any trends within the data difficult to determine (Table 5).
Patients’ Satisfaction With the Pilot Program
The 8 patients who completed the Beating Fatigue program assisted in its review. Their views on the information package and domiciliary visits and their perception of the program as a whole are presented in the following sections.
EVALUATION OF THE INFORMATION PACKAGE
Patients evaluated different aspects of the information package on a rudimentary scale of 1 to 4, with 1 representing the most unfavorable response and 4 the most unfavorable. Patients found the information sheets easy to read (mode = 1, range 1-2) and understand (mode = 1, range 1-2). They found the preparatory information regarding the pattern and characteristics of fatigue after chemotherapy helpful (mode = 1, range 1-3). The comments made by patients regarding the preparatory information included “At the beginning you are so shocked, and you assimilate information slowly over time, so information at the early stages is very important.” Another explained: “You worry about the unknown, and information sets your mind at rest—the sooner the better.” In contrast, one patient would have preferred to receive the information later, once the patients adjusted to the diagnosis.
However, patients displayed a degree of ambivalence toward the self-care information describing strategies for the relief of fatigue. This was evident in their rating of its helpfulness (mode = 2, range 2-3) and their comments, which included “It was neither one nor the other—helpful or unhelpful.” This was reflected further in the number of times they read the information. Without exception, subjects had referred to the information only once or twice, rather like a reference book that is comforting to have, though seldom used.
Subjects were given the written information according to needs and preferences at each visit; however, patients expressed a wish to have all of the information at the outset, and this suggestion was incorporated into the main study.
EVALUATION OF THE DOMICILIARY VISITS
The domiciliary visits were perceived in general as very helpful (mode = 1, range 1-3), and the advice provided by the support nurse was considered very useful (mode = 1, range 1-2) on the whole. Patients explained that the visits were “reassuring and encouraging,” one patient explained that “it is easy to become isolated.” These psychosocial aspects of the nurse’s visits predominated over educational ones. One patient explained that she could not remember the support nurse’s advice but stressed that she had gained from the visits through “feeling more at ease” as a result. She perceived her fatigue to be related to her psychologic status that had benefited from the nurse’s support.
Subjects perceived the support nurse’s approach as appropriate and beneficial. All of the subjects praised her interpersonal characteristics. Some appreciated her sense of humor and listening skills, while another commented that he was not a “jokey” character, thereby implying that humor would be inappropriate for him. However, this gentleman praised her empathy instead. These data would suggest that through her empathy and sensitivity, the support nurse struck the correct chord with the patients and adapted her approach and style accordingly.
To keep the visits as standard as possible, the support nurse was scheduled to meet with patients at the end of the first week of treatment. In reality this was not always possible due to subjects’ work and other social commitments. All but one of the patients opted for the support nurse to visit at home. One subject was interviewed during routine hospital visits. These hospital-based interviews were compromised because they were conducted in a noisy outpatient environment and hampered by the limited time the patient had available. A decision was made that in the main study, when possible, all visits would be conducted in the home.
To determine the relative value of the program’s components, patients were requested to rank the relative value of the different aspects from 1 to 5, with the most valuable aspect being attributed a value of 1, the second most valuable attributed a value of 2, and so on. The results from this ranking exercise are presented in Table 6.
The aspect that was rated most highly was having the opportunity to talk to somebody. This reduced patients’ feelings of isolation and prevented them from feeling alone in managing their symptoms or dealing with their problems. Conversely, having the opportunity to explore fatigue was considered relatively unimportant. This apparent paradox may reflect patients’ reluctance to dwell on or acknowledge fatigue or may reflect some difficulties in their discussion of this nebulous symptom. One person considered the exploration of fatigue vital because it enabled her to determine “what is and is not fatigue.” The written information, while being evaluated with some ambivalence, was ranked third highest overall. Some subjects reflected on the structure of the intervention and stressed that it was helpful to receive the information before the domiciliary visits because it enabled them to discuss strategies in an informed manner. One subject summarized the value of the fatigue program in the following manner “I wouldn’t have coped as well with fatigue without the information about the different strategies. I have found ways of coping with fatigue.”
The subjects all believed that they had benefited from the fatigue intervention. They stated that it had enabled them to cope better than they otherwise would have done, not only with fatigue but also with their illness. It is encouraging that in the two latter treatments, the fatigue experienced during the majority of the third cycle was lower than that in the second, which could indicate that the upward trend may have been halted and patients were beginning to master effective strategies for managing it. Previous research suggested that in the absence of intervention, fatigue rises with treatment. 41 Favorable outcome data suggested that the program may also have significant benefit for patients’ emotional well-being, notably in terms of feelings of depression. However, although these preliminary data are encouraging, they are limited and it is difficult to interpret these tentative findings in the absence of a control group.
The sample in this study included patients across the disease trajectory. The majority of participants were receiving adjuvant therapy, but a small number were receiving palliative treatment. The emotional outlooks of patients within these different groups and the intensities of their fatigue will differ along with the meaning that fatigue holds for their lives. 42,43 Thus, the communication skills and knowledge of fatigue held by the support nurse is clearly vital. The approach she adopted varied according to patients’ emotional well-being, apparent coping, and outlook. Although the information booklet contained general information intended for use at all stages of patients’ illness, the support nurse was charged with individualizing the information to meet need. Unfortunately, because the sample was small, it was difficult to perform any between-group comparison to determine how the different groups responded. In the main study this important point will be addressed.
The subjects perceived the conversation and support provided by the support nurse as the most effective aspects of the intervention. Through the domiciliary visits the nurse was able to answer queries, raise patients’ mood and morale, encourage a positive outlook, and, for one patient, engender feelings of control. However, although two thirds of the patients considered the written information interesting and fairly helpful and they were anxious to have preparatory information before their treatment, they were ambivalent toward the self-care information, which they appeared reluctant to adopt. This paradox could result from the unprofessional and crowded appearance of the information that had not been professionally produced. This could have discouraged patients from rereading and implementing it and, thus, could have prevented it from being used to its full potential. To prevent this from occurring in the main study, the information pack was reviewed by an experienced medical writer who altered its layout and inserted discrete illustrations to make the information less cramped and more visually appealing. It could, however, also reflect the reluctance of patients with cancer at times to read patient literature that is given to them 44 for fear that it could instill fear within them and destroy the hope they have for their future.
Furthermore, the experience with the pilot study would suggest that although patients find information about fatigue and chemotherapy useful, they do need assistance in applying it, particularly when they are fatigued and lacking motivation. Thus, the input of the support nurse was crucial in encouraging subjects to derive optimal benefit from the program. Therefore, the support nurse determined to concentrate her efforts on developing skills and strategies that would empower and motivate patients in the main study. Although during the pilot the support nurse strove to see patients at the end of the first week of treatment, this was not always possible. It was decided that for the main study a degree of flexibility would be introduced and the visits would be conducted within 7 to 10 days of treatment.
Data from the pilot study supported the global approach to managing fatigue adopted for this study. The ranked data presented in Table 6 identifies that although patients overall perceived having the opportunity to talk to someone about fatigue as the most beneficial strategy, patients individually varied in their preferred aspect. Thus it would appear that a multifaceted approach to the management of fatigue is appropriate because it enables the intervention to be tailored to individual requirements.
Beating Fatigue is a multifaceted program based on education, monitoring, and coaching aimed at facilitating patients’ management of and adaptation to fatigue. This pilot study provided evidence for its application in the main study. Patients considered the approach valuable and it helped their coping, not only with this symptom but also with their treatment generally. Measurement of fatigue suggested that by the third treatment patients were managing it better. The appropriateness of the multifaceted program was endorsed by the subjects who identified different aspects of the intervention that each favored. The importance of the relationship between the support nurse and individual patients became evident. The support nurse was able to adapt her approach and tailor the program to individual needs. This increased the efficacy of the intervention. However, for interventions to be standardized and replicable, those developing them must be mindful of introducing too much variability. Consistency can be facilitated, as in this study, through the development of intervention interview schedules, the prescribed timing of events, administration of uniform information (in this case, the Beating Fatigue pack), and completion of standardized tasks, such as diary keeping. Through the pilot work the multifaceted approach was reflected upon and through recourse to patient views adapted to optimize effect. Results from the main study will be reported on in due course.
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