Approximately 20 to 40 percent of newly diagnosed cancer patients experience significant levels of psychological and emotional distress.1,2 Women undergoing mastectomy for breast cancer may suffer additional psychosocial distress because of their life-threatening diagnosis and body image distortions.3–5 Preoperative depression, distress, and anxiety have been shown to be predictive of reduced satisfaction 1 and 2 years after mastectomy breast reconstruction, and all preoperative psychosocial variables inversely affect surgical outcomes and patient satisfaction.3 The goals of breast reconstruction are to restore the form and psychosocial function and to recreate a breast mound that satisfies the patient. Therefore, it is important to measure the success of breast reconstruction within the context of these dimensions of psychosocial health.3,4,10,11
Recent attention has been directed toward breast reconstruction timing (delayed versus immediate) with restoration of body image, sexuality, and psychosocial outcomes.6–9 Studies have indicated superior postoperative psychosocial benefits following immediate breast reconstruction compared to delayed breast reconstruction.4,12–14 However, immediate breast reconstruction patients may endure greater preoperative psychosocial distress because of fear associated with the recent breast cancer diagnosis and potential complications with their pending operations.15–17 However, the literature in this area is limited to cross-sectional studies that have compared psychosocial function between immediate and delayed breast reconstruction at only one postoperative time point. Understanding the prereconstruction dimensions of psychological and emotional distress in patients with a recent breast cancer diagnosis, and the impact of immediate and delayed breast reconstruction on psychological outcomes at various time points along the breast reconstruction trajectory, will substantially add to our understanding of the dynamic process of psychosocial recovery. Therefore, the aims of this study were to prospectively evaluate health-related quality of life, body image, sexuality, and psychological responses (anxiety and depression) in women with breast cancer before and at various time points after breast reconstruction.
PATIENTS AND METHODS
Patients and Procedures
After approval by the University Health Network Research Ethics Board (no.10-0317-CE, September 3, 2010), patients were recruited from June 1, 2009, to December 31, 2010, from the University Health Network (Toronto, Ontario, Canada). Inclusion criteria were as follows: (1) adult female patients (>18 years); (2) diagnosis of in situ or invasive breast cancer; (3) undergoing microsurgical autologous tissue reconstruction; and (4) able to read and write English. Before undergoing breast reconstruction, eligible patients were sent a study consent form, demographic/clinical data form, and four questionnaires. Consented patients were asked to complete the questionnaire before surgery and at 6, 12, and 18 months after surgery.
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale is a 14-item, validated, self-administered screening questionnaire that measures symptoms of anxiety (seven items) and depression (seven items).18 Scores range from 0 to 21 for both anxiety and depression subscales, with higher scores indicating higher levels of symptoms (normal, 0 to 7; borderline abnormal, 8 to 10; and abnormal, 11 to 21). Excellent internal consistencies are reported: 0.84 for anxiety and 0.86 for depression.18
Body Image Scale and Sexuality Scale
The Body Image Scale is a cancer-specific measure to assess satisfaction with body image.19 Psychometric testing showed excellent reliability (Cronbach alpha, 0.93) and validity, with higher scores representing more concerns with body image. We included the following five Body Image Scale dimensions: (1) satisfaction with appearance when dressed, (2) feeling feminine, (3) satisfaction with appearance when naked, (4) feeling sexually attractive, and (5) feeling conscious about appearance. The Sexuality Scale dimensions included the following: (1) spontaneous sexual interest, (2) frequency of sexual intercourse, (3) adequacy of arousal, (4) influence of pain on sexual functioning, and (5) general satisfaction with sexual life.20 Excellent reliability for the Sexuality Scale has been reported (Cronbach alpha: pretest, 0.86; 1-year follow-up, 0.90).
The BREAST-Q is a validated, procedure-specific, patient-reported measure to assess health-related quality of life and patient satisfaction after breast reconstruction.21–23 Four subscales were included in this study to assess before and after breast reconstruction, as follows: (1) satisfaction with breasts, (2) psychosocial well-being, (3) sexual well-being, and (4) physical well-being with chest and abdomen donor site. Higher scores (range, 0 to 100) indicate greater satisfaction or function. Psychometric evaluation reveals excellent internal consistency (Cronbach alpha, 0.88 to 0.96) and test-retest reliability (intraclass correlation coefficient, 0.85 to 0.98).21–23
Our selection criteria for the method and timing of breast reconstruction are consistent with the Clinical Guidelines and Recommendations for Breast Cancer Reconstruction published for Cancer Care Ontario.24 Immediate breast reconstruction was usually offered to women with in situ breast disease, or stage I or II breast cancer with no regional lymph node disease, and for whom the requirement for postmastectomy radiation therapy was not anticipated.25–28 However, select patients for whom the requirement for radiation therapy was anticipated and who strongly desired immediate breast reconstruction, and fully understood the negative effects of irradiating the breast mound, were still provided immediate breast reconstruction. Although the delayed-immediate method of reconstruction is an excellent option for a patient with intermediate risk of requiring postmastectomy radiation therapy, this was not used in the time frame of this study.29,30 Autologous reconstruction was offered to women with a history of chest irradiation, available donor tissues, and/or nonpliable chest wall soft tissues and was performed by one of two surgeons (T.Z. and S.O.PH.).
Descriptive analyses of demographic, clinical, and surgical characteristics were performed. Differences between timing groups (immediate/delayed breast reconstruction) were tested using Fisher’s exact tests (categorical variables) or Wilcoxon rank sum tests (continuous variables). BREAST-Q scores were generated using the QScore software. The mean, standard deviation, and range of outcomes were calculated. Differences between groups at each time point were assessed using the Wilcoxon rank sum test. The software program lme431 was used to perform the linear mixed effects analysis between each repeated outcome and follow-up time point after controlling for the timing group. The p values were obtained using the likelihood ratio tests. Changes in BREAST-Q score from prereconstruction baseline were calculated by subtracting the score at 12 months from the prereconstruction value; differences between the groups were assessed using a generalized linear regression model. Cohen d was used to quantify the effect size of immediate and delayed breast reconstruction for the BREAST-Q subscales; less than 0.2 indicated a “trivial” effect size, 0.2 to 0.5 indicated a “small” effect size, greater than 0.5 to 0.8 indicated a “medium” effect size, and greater than 0.8 indicated a “large” effect size.32 All analyses were performed using R software version 3.0.2. All tests were two sided, with significance at p ≤ 0.05. This study was powered to detect a difference between the two groups (immediate and delayed breast reconstruction) at 80 percent power and alpha error of 0.05. Based on a large effect size for the BREAST-Q score between the delayed breast reconstruction and immediate breast reconstruction groups, 25 patients were required in each group.
During the study period, 106 women diagnosed with breast cancer underwent mastectomy with immediate (n = 30) and delayed breast reconstruction (n = 76). In the delayed breast reconstruction group, the mean time from mastectomy to breast reconstruction was 2.8 years (range, 5 months to 18 years). No patient in the delayed breast reconstruction group underwent any intermediate interventions or insertion of tissue expander. Follow-up questionnaires were completed by 75 percent of subjects at 6 months, 82 percent at 12 months, and 69 percent at 18 months. Table 1 summarizes the patient clinical and surgical characteristics. There were significantly more patients with invasive breast cancer in the delayed breast reconstruction (58 percent) compared with the immediate breast reconstruction (34 percent) group (p = 0.01). Significantly more patients in the delayed breast reconstruction group had prior chemotherapy (79 percent) and were actively receiving hormonal or endocrine therapy (58 percent) compared with the immediate breast reconstruction group (23 percent and 10 percent, respectively).
Hospital Anxiety and Depression Scale
Before breast reconstruction, 26 percent of patients (27 of 106) had abnormal anxiety scores (≥11) and 9 percent (nine of 106) had abnormal depression scores (≥11). There was no statistically significant difference in the proportion of subjects with abnormal anxiety (immediate breast reconstruction, 24 percent; delayed breast reconstruction, 27 percent) or depression (immediate breast reconstruction, 7 percent; delayed breast reconstruction, 10 percent) at baseline (Fig. 1) and no difference in the mean anxiety scores (immediate breast reconstruction, 7.9 ± 5.0; delayed breast reconstruction, 8.2 ± 4.8). Following breast reconstruction, the anxiety scores decreased significantly in both groups (p < 0.01), and there were no significant differences in the anxiety scores between the groups at any follow-up times. There was no significant difference in prereconstruction depression scores between immediate (2.9 ± 3.7) and delayed breast reconstruction (4.1 ± 3.8). However, the mean depression scores decreased significantly over time in the delayed breast reconstruction group (6 months, 3.2 ± 3.8; 12 months, 2.8 ± 3.1; 18 months, 2.7 ± 3.4; p = 0.002), and there was no significant change in the immediate breast reconstruction group (p = 0.5).
Body Image Scale and Sexuality Scale
Figure 2 shows the changes in Body Image Scale and Sexuality Scale mean scores at each time point between groups. The prereconstruction Body Image Scale score was significantly lower (p = 0.01) in the immediate breast reconstruction (29.7 ± 10.2) compared with the delayed breast reconstruction group (35.7 ± 8.7). Following breast reconstruction, the Body Image Scale significantly improved in both groups (p < 0.01), and there were no differences at any follow-up time point between immediate breast reconstruction (6 months, 25.2 ± 7.7; 18 months, 20.5 ± 8.4) and delayed breast reconstruction (6 months, 23.8 ± 8.4; 18 months, 24.3 ± 8.9). The mean Sexuality Scale score at baseline was significantly lower with immediate breast reconstruction (31.1 ± 8.5) compared with delayed breast reconstruction (35.7 ± 7.5) (p = 0.01). Both groups had significantly improved Sexuality Scale scores over time (p < 0.01); at 6 months, the Sexuality Scale score was significantly lower (p = 0.04) in the delayed breast reconstruction group (mean, 28.8 ± 6.2) compared with the immediate breast reconstruction group (mean, 30.3 ± 7.2), and there was no statistical differences at 18 months (p = 0.53).
Before breast reconstruction, the mean BREAST-Q scores (satisfaction with breasts, psychosocial well-being, and sexual well-being) were significantly lower in the delayed breast reconstruction compared with the immediate breast reconstruction group (Table 2). At 12 months after reconstruction, the score differences were not statistically significant. There were no significant differences between the two groups in physical well-being at any time point. The change scores for each subscale between before reconstruction and 12 months after reconstruction for the immediate and delayed breast reconstruction groups were evaluated using Cohen d effect sizes (Fig. 3). The satisfaction with breast subscale improved significantly (p < 0.01) in the delayed breast reconstruction group (from 35.2 ± 18.1 to 70.6 ± 15.9), and there was no change in the immediate breast reconstruction group. The effect size for the change in satisfaction with breasts from before reconstruction to 12 months after reconstruction in the delayed breast reconstruction group was 1.34 (large effect) compared to immediate breast reconstruction. The psychosocial well-being and sexual well-being subscales after reconstruction improved significantly in the delayed breast reconstruction group compared with the immediate breast reconstruction group (p < 0.04). The effect size of delayed breast reconstruction compared with immediate breast reconstruction was medium for both psychosocial well-being (0.56) and sexual well-being (0.6).
The goal of breast reconstruction is to restore breast appearance and to improve psychological outcomes following cancer ablation. Psychological benefits, body image, sexuality, and health-related quality-of-life changes may differ based on the timing of breast reconstruction.33–36 Assessment of patient outcomes and psychological responses using validated instruments is essential to determine success from the patient’s perspective.37,38 Using generic distress, cancer-specific, and procedure-specific measures, we prospectively evaluated health-related quality of life, body image, sexuality, anxiety, and depression in breast cancer patients who underwent immediate compared to delayed breast reconstruction. Before breast reconstruction, patients with mastectomy defects awaiting delayed breast reconstruction had significantly worse body image, sexuality, and health-related quality-of-life domains (psychosocial and sexual well-being), and were less satisfied with their breasts compared with the immediate breast reconstruction patients. The medium to large effect size for all three BREAST-Q subscales suggests that improvements achieved by breast reconstruction were more clinically significant in the delayed breast reconstruction patients compared with immediate breast reconstruction patients. In all patients, breast reconstruction successfully improved body image, sexuality, psychosocial and sexual well-being, and satisfaction, with no significant differences between delayed breast reconstruction and immediate breast reconstruction at long-term follow-up.
Consistent with the literature, our patient cohort had a high level of anxiety, with approximately 26 percent having a Hospital Anxiety and Depression Scale score consistent with a screening diagnosis of clinical anxiety.1,2 However, we observed a relatively low prevalence of clinical depression (9 percent had a Hospital Anxiety and Depression Scale score for clinical depression). Contrary to previous studies, we did not observe any significant differences in the prereconstruction anxiety or depression levels between immediate and delayed breast reconstruction groups.3 We initially hypothesized that women in the immediate breast reconstruction group newly diagnosed with invasive breast cancer would have significantly higher levels of anxiety compared with delayed breast reconstruction patients who had been cancer-free following mastectomy surgery (mean, 2.8 years). The comparable prereconstruction levels of emotional distress found in this study may be partly because our immediate breast reconstruction group had earlier stage breast cancer (77 percent versus 61 percent had in situ or stage I/II), lower frequency of adjuvant therapies (33 percent versus 57 percent prior irradiation, 23 percent versus 79 percent prior chemotherapy), and active endocrine/hormonal therapy use (10 percent versus 58 percent) compared with the delayed breast reconstruction group. The less aggressive nature of breast cancer and treatment in the immediate breast reconstruction group may have contributed to less emotional distress, therefore leading to similar levels of anxiety and depression as delayed breast reconstruction patients. Following breast reconstruction, there was decreased anxiety (p < 0.01) and depression levels (p = 0.002) in the delayed breast reconstruction group, and only anxiety levels were reduced in the immediate breast reconstruction group (p < 0.01). As in a previous report comparing immediate and delayed breast reconstruction at 6 months after reconstruction, anxiety and depression levels were not significantly different between groups.39
Before breast reconstruction, our delayed breast reconstruction patients had significantly greater distortion in body image and sexuality compared with the immediate breast reconstruction patients. These data may imply that women preparing to undergo delayed breast reconstruction had suffered significant body image and sexuality impairment following their mastectomy surgery. This is similar to the finding reported by Metcalfe et al. that the prevalence rate of body dysmorphic disorder as detected by a previously validated instrument in the delayed breast reconstruction group was significantly higher (34 percent) compared with the immediate breast reconstruction group (13 percent).40 At 6 months after reconstruction, body image differences between the two groups no longer existed; however, sexuality remained significantly (p = 0.04) worse in the delayed breast reconstruction group compared with the immediate breast reconstruction group. At 12 and 18 months after surgery, the differences in sexuality scores between the two groups were no longer significant (p = 0.53). Body image and appearance concerns may be restored in a relatively short time frame once the breast mound has been created; however, intimacy and sexuality disruptions may require a longer recovery period.
The strengths include a prospective study design; high response rate; and use of valid and reliable, procedure-specific (BREAST-Q), generic distress (Hospital Anxiety and Depression Scale), and cancer-specific (Body Image Scale) measures. Prospective data allowed us to compare the evolution of outcomes with each patient as her own control. The measurements at specific time intervals following breast reconstruction avoided the potential bias inherent in assessing health-related quality of life at varying durations after surgery.16,41–49 Lastly, because different methods of breast reconstruction (implants versus tissue reconstruction) have been shown to significantly affect patients’ psychological responses and quality of life to varying degrees,47,50 we have eliminated this as a major potential confounder by exclusively studying patients who have had autologous tissue breast reconstruction.
Without a comparison group of patients who underwent mastectomy only, the gain in health-related quality of life and satisfaction following breast reconstruction loses its contextual value. In particular, mastectomy patients who do not choose to undergo any form of breast reconstruction may have the least psychosocial impairment, and thus excluding them from this study may contribute to selection bias, resulting in a higher rate of psychosocial distress in the delayed breast reconstruction group reported here. It is important to note that the delayed breast reconstruction group in our study represents a very specific subpopulation of mastectomy patients who may not have been offered or who may have declined immediate breast reconstruction, and therefore are not representative of all mastectomy patients. Although delayed breast reconstruction patients may be denied immediate breast reconstruction because of a sound oncologic reason such as having advanced breast cancer, it is plausible that they may suffer greater dissatisfaction and poor psychological response following mastectomy. Although delayed breast reconstruction is appropriate over immediate breast reconstruction in patients who have advanced breast cancer with regional lymph node involvement who will require timely delivery of adjuvant therapy, there was a greater proportion of delayed breast reconstruction (72 percent) compared with immediate breast reconstruction patients (28 percent) in our cohort, which may be reflective of the conservative use of immediate breast reconstruction in the in situ and invasive breast cancer population in Canada, and may not mirror the expanding use of immediate breast reconstruction in the United States.51,52 Our previous examination of patterns of immediate breast reconstruction using Ontario data suggests that there are many barriers to patients undergoing immediate breast reconstruction in our universal health care system that include a shortage of plastic surgeons performing immediate breast reconstruction and scarce resources for the operating room to accommodate a longer immediate breast reconstruction, especially with complex microsurgical reconstruction.51
Patients awaiting delayed breast reconstruction had significantly impaired body image, sexuality, and health-related quality of life functioning compared to immediate breast reconstruction patients. Our long-term prospective results following surgery revealed that both immediate and delayed breast reconstruction successfully improved body image, sexuality, and health-related quality of life to comparable levels. The clinical implication is that in patients who are suitable oncologic candidates for immediate breast reconstruction and are strongly motivated, every effort should be made to coordinate immediate breast reconstruction with mastectomy. In patients where the decision is made to delay reconstruction until all adjuvant therapies have been completed, the wait time should be expedited to minimize the duration of psychosocial distress. It may provide reassurance to delayed breast reconstruction patients that body image and appearance concerns are likely restored relatively quickly after surgery, and intimacy and sexual well-being, although slower to normalize, will reach levels comparable to those of immediate breast reconstruction patients by 12 to 18 months. Because many early-stage breast cancer patients are making well-informed, patient-driven decisions to undergo immediate breast reconstruction, this study provides compelling evidence based on patient-reported outcomes that the immediate breast reconstruction program must be supported to meet these increasing demands.
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