Breast Cancer Prevention Trial Symptom Research Articles

A methodological review of the Short Form Health Survey 36 (SF-36) and its derivatives among breast cancer survivors.

A systematic review of the validity, reliability and sensitivity of the Short Form (SF) health survey measures among breast cancer survivors. We searched a number of databases for peer-reviewed papers. The methodological quality of the papers was assessed using the COnsenus-based Standards for the selection of health Measurement INstruments(COSMIN). The review identified seven papers that assessed the psychometric properties of the SF-36 (n=5), partial SF-36 (n=1) and SF-12 (n=1) among breast cancer survivors. Internal consistency scores for the SF measures ranged from acceptable to good across a range of language and ethnic sub-groups. The SF-36 demonstrated good convergent validity with respective subscales of the Functional Assessment of Cancer Treatment-General scale and two lymphedema-specific measures. Divergent validity between the SF-36 and Lymph-ICF was modest. The SF-36 demonstrated good factor structure in the total breast cancer survivor study samples. However, the factor structure appeared to differ between specific language and ethnic sub-groups. The SF-36 discriminated between survivors who reported or did not report symptoms on the Breast Cancer Prevention Trial Symptom Checklist and SF-36 physical sub-scales, but not mental sub-scales, discriminated between survivors with or without lymphedema. Methodological quality scores varied between and within papers. Short Form measures appear to provide a reliable and valid indication of general health status among breast cancer survivors though the limited data suggests that particular caution is required when interpreting scores provided by non-English language groups. Further research is required to test the sensitivity or responsiveness of the measure.

Quality of life among breast cancer survivors treated with breast-conserving therapy in Hawaii.

154 Background: Aim of this study was to compare quality of life (QOL), treatment-related side effects, and needs of recent and long-term breast cancer survivors following breast-conserving therapy. Methods: Surveys were sent to 750 women with Tis, T1 – T4 breast tumors without lymph node involvement who received lumpectomy followed by radiotherapy at a large, tertiary care facility in Hawai‘i from January 2001 to December 2010. To assure adequate representation across years, 75 women were randomly selected from each year. Surveys included demographic items, City of Hope Quality of Life – Breast Cancer Instrument, and Breast Cancer Prevention Trial Symptom Scales. Completed surveys were received from 265 (35.3%) women, and findings were analyzed for long-term survivors (diagnosed from 2001-2003, n=76), mid-range survivors (diagnosed from 2004-2007, n=95), and recent survivors (diagnosed from 2008-2010, n=94). Results: Overall, respondents reported high QOL. Similarly to recent breast cancer survivors, long-term survivors reported slight to moderate side effects, including hot flashes, vaginal problems, musculoskeletal pain, and cognitive dysfunction. After controlling for age, ethnicity, and cancer stage, there was no significant differences in QOL physical, psychological, and social well-being subscale scores across time periods. Long-term survivors were more likely than shorter-term survivors to want information regarding nutrition (p<.01), physical activity (p=.018), and ways to restore strength, mobility, and cognition (p<.01). Conclusions: Breast cancer survivors treated with breast conserving therapy report relatively good QOL between 2 and 12 years post-treatment, although they continued to experience physiological issues (which could be exacerbated by age), and anxieties about their cancer. Healthcare professionals should continually assess for ongoing cancer-related side effects even years after completing treatment. Funding: This research was supported by ‘Imi Hale Native Hawaian Cancer Network (U54 CA153459).

Sexual functioning in young women with breast cancer.

9100 Background: Sexual dysfunction is a known complication of adjuvant therapy for breast cancer and an important determinant of quality of life. Little is known about the frequency and magnitude of this problem among very young women with breast cancer during the year following diagnosis. Methods: 298 sexually-active women enrolled in an ongoing multi-center cohort study with Stage 0-III breast cancer at or before age 40 were included in this analysis. Treatment data was self-reported on a survey mailed to participants at enrollment. Sexual functioning was assessed using the sexual interest and dysfunction subscales from the Cancer Rehabilitation Evaluation System (CARES). Scores range from 0-4, with higher scores indicative of poorer function. The survey included a measure of anxiety and depression (Hospital Anxiety and Depression Scale), of body image (CARES) and of physical and menopausal symptoms (Breast Cancer Prevention Trial Symptom Checklist). Mean differences in CARES scores between treatment groups (chemotherapy vs. none; hormone therapy vs. none; lumpectomy vs. mastectomy vs. mastectomy + reconstruction vs. no surgery; radiation vs. none) were compared using T-tests and ANOVA. Multiple regression models were fit to assess symptoms thought to be mediators of the treatment-sexual functioning association. Results: Mean age at diagnosis was 36 (range: 22-40) years and mean time from diagnosis to survey completion was 5 months (range: 1-16). Mean CARES sexual interest and dysfunction scores were higher in women who received chemotherapy compared to those who did not (p<0.0001). In the multivariate analysis, chemotherapy was no longer associated with decreased sexual interest or function. Anxiety, depression, musculoskeletal pain, and poorer body image were predictive of both decreased sexual interest and function. Vaginal pain symptoms were associated with greater dysfunction, while unhappiness with appearance was associated with decreased interest. Conclusions: Young women who receive chemotherapy are at risk for problems related to sexual functioning early in the survivorship period. This effect appears to be mediated through several physiologic and psychologic mechanisms, underscoring the need for interventions that target both.

Evaluation of the psychometric properties of the BCPT Symptom Checklist with a sample of breast cancer patients before and after adjuvant therapy

The purpose of this analysis was to provide psychometric information related to the Breast Cancer Prevention Trial (BCPT) Symptom Checklist in women with breast cancer prior to the initiation of adjuvant therapy and 6 months post-initiation of therapy. This investigation was a secondary analysis of baseline data from the Anastrozole Use in Menopausal Women (AIM) Study (R01 CA 107408). The data used in this study were obtained from women diagnosed with Stage I, II, and IIIa breast cancer and who received adjuvant therapy that included chemotherapy alone, anastrozole alone, and chemotherapy plus anastrozole. Data were examined before adjuvant therapy (n=278), and at 6 months post-adjuvant therapy (n=195). Construct validity was examined through exploratory and confirmatory factor analysis (CFA), and the internal consistency of each resulting subscale was computed. Discriminant validity evidence was obtained by correlating BCPT subscales with subscales from the MOS SF-36. A seven-factor structure was extracted from the 42 items at baseline; an eight-factor structure was found using 6-month data. CFA was performed to compare the baseline and 6-month models as well as an eight-factor model recommended by Cella et al. Findings revealed that the two eight-factor models best represented the data. Low negative correlations with the subscales of the MOS SF-36 provided discriminant validity evidence. This analysis provides evidence for the reliability, discriminant validity, and factor structure of the BCPT Symptom Checklist. Further testing of this instrument is needed to confirm the factor structure of this measure.

Predictors of nonadherence to oral adjuvant hormonal therapy for breast cancer.

e11095 Background: Nonadherence to oral hormonal therapy has been well-documented. Fail to adhere to the adjuvant may lead to increase recurrence. Nonadherent behavior to oral medication was not limited to taking less but also alternating dose or schedule. The purpose was to investigate the indication of nonadherence behaviors to oral adjuvant hormonal therapy and the predictors of nonadherence in a sample of 125 women with breast cancer, receiving oral adjuvant hormonal therapy from 4 sites across Taiwan. Methods: Nonadherence was measured both by self-report and prescription refill data printed on the drug bottles. The self-reported measure was a 7-item 5-points scale, for level of adhering to the frequency, dosage and schedule for the past month. The non-adherence was also defined as fewer than 80% of pills according to the prescription and refill information. Predicators being investigated included the menopausal related symptom as measured by Breast Cancer Prevention trial Symptom Checklist, decisional conflict as measured by Decisional Conflict Scale, physician communication and socio-demographic-clinical data. Multivariate analysis was used to determine the predictors. Results: A majority of were in mid-age, married and receiving tamoxifen (68.8%). Results indicated 70%-82.4% women reported to have cognitive, sleep and fatigue issues; 60% of them being distressed with sexual issues. Hot flash and night sweat were only accounted for 48% and 37.6%. But 10% of the women reported to have more than 5 times of hot flash and night sweat, and woke up 3-4 times per night. 28% reported stopped taking the pills several times, about 10% alternated the dose, schedule and frequency. 27.8% were nonadherent according to refill data. The multiple regression analysis indicated that the nonadherent were more likely to be those who had been under the treatment longer, uncertainty about the adjuvant hormonal therapy and experienced bladder control issues. Conclusions: The findings indicated the nonadherent behaviors might go beyond taking less. An integrated intervention to assist these women to adhere the oral adjuvant is important. No significant financial relationships to disclose.

Aromatase inhibitor-associated arthralgia: Prevalence, clinical and serum parameters among Turkish postmenopausal breast cancer patients

11525 Background: The frequency of aromatase inhibitor (AI)-associated arthralgia is reported to be between 5–47% among various adjuvant studies. We aimed to investigate the prevalence and pathogenesis of AI associated arthralgia in patients with breast cancer. Methods: Fifty-three postmenopausal women with hormone receptor-positive breast cancer receiving adjuvant AI treatment were involved. Musculoskeletal symptoms were assessed by using Breast Cancer Prevention Trial (BCPT) symptom scales. Serum anti-nuclear antibody (ANA), anti-DNA antibody, erythrocyte sedimentation rate, C reactive protein, anti-cyclic citrullinated peptide antibodies (anti-CCP), rheumatoid factor (RF) levels were measured. Articular/periarticular ultrasonogram was performed for involved joints and electromyogram (EMG) of upper and lower extremities was performed for neuropathy. Results: Median age of the patients was 57 and median duration of AI use was 12 months. Thirty patients were receiving anastrozole, 22 receiving letrozole and one exemestane. 21 patients (39.6%) had AI- associated new-onset or worsening arthralgia. Most frequently involved joints were knee (67%), small joints of the hand (57%) and ankle (38.9%) joints. 26.4 % of the patients had ANA positivity (titer 1/80–1/160, homogenous or speckled pattern), 5.7% had anti-DNA positivity, 5.7% had anti-CCP positivity, 35.8% had RF positivity, 40% had osteoporosis, 57% had effusion in the effected joints, 72% had EMG findings consistent with carpal tunnel syndrome. The only differences between the patients with and without arthralgia were ANA and anti-DNA positivity rates; 40% vs. 19% for ANA, p=0.1, and 14% vs. 0% for anti-DNA, p=0.055, respectively. Conclusions: A significant fraction of patients using AIs experiences arthralgia. This study showed that an autoimmune process may be responsible for arthralgia in at least a proportion of the patients. No significant financial relationships to disclose.

Menopausal-type symptoms in young breast cancer survivors

BackgroundThere has been little previous information available about menopausal-type symptoms in very young breast cancer survivors. MethodsIn collaboration with the Young Survival Coalition, we conducted an Internet-based survey of women with a history of breast cancer diagnosed at age 40 years or younger using items derived from the Breast Cancer Prevention Trial symptom checklist. ResultsA total of 371 respondents were eligible for analysis. Mean age at diagnosis was 32.8 years and mean age at follow-up 36.2 years; 89% of women received chemotherapy, 49% tamoxifen, 15% ovarian suppression, 4% aromatase inhibitors. At the time of survey, 37% were taking tamoxifen and 9% ovarian suppression. Excluding women on ovarian suppression, 77% of women were premenopausal at follow-up. Many women reported bothersome menopausal-type symptoms. In particular, 46% of women reported hot flashes and 39% reported dyspareunia. In a linear regression model of symptom scores, current ovarian suppression, postmenopausal status, baseline anxiety before the diagnosis, pregnancy after the diagnosis, prior chemotherapy, and lower perceived financial status were associated with more bothersome symptoms. ConclusionA substantial number of young breast cancer survivors experience bothersome menopausal symptoms. While the women who responded to our survey may represent a select group of survivors, these findings may have important implications for treatment decision making and long-term quality of life of young women with breast cancer.

Fatigue in long‐term breast carcinoma survivors

A longitudinal study was designed to evaluate the prevalence, persistence, and predictors of posttreatment fatigue in breast carcinoma survivors. A sample of 763 breast carcinoma survivors completed questionnaires at 1-5 and 5-10 years after diagnosis, including the RAND 36-item Health Survey, Center for Epidemiological Studies - Depression scale (CES-D), Breast Cancer Prevention Trial Symptom Checklist, and demographic and treatment-related measures. Approximately 34% of study participants reported significant fatigue at 5-10 years after diagnosis, which is consistent with prevalence estimates obtained at 1-5 years after diagnosis. Approximately 21% reported fatigue at both assessment points, indicating a more persistent symptom profile. Longitudinal predictors of fatigue included depression, cardiovascular problems, and type of treatment received. Women treated with either radiation or chemotherapy alone showed a small improvement in fatigue compared with those treated with both radiation and chemotherapy. Fatigue continues to be a problem for breast carcinoma survivors many years after cancer diagnosis, with 21% reporting persistent problems with fatigue. Several factors that may contribute to long-term fatigue are amenable to intervention, including depression and comorbid medical conditions.

Psychometric properties of a tool for measuring hormone-related symptoms in breast cancer survivors

Hormone-related symptoms are common in breast cancer survivors and many aspects of these symptoms are currently under study. Reliable and valid assessment tools are needed to successfully study hormone-related symptoms in breast cancer survivors; however, no gold standard currently exists for measuring these symptoms. This study evaluated the psychometric properties of a shortened version of the Breast Cancer Prevention Trial (BCPT) symptom checklist in a sample of 803 breast cancer survivors. Principal factor analysis with Promax oblique rotation revealed a five-factor structure, identifying five separate hormone-related symptoms scales: vasomotor symptoms, urinary incontinence, cognitive/mood changes, vaginal symptoms, and weight gain/appearance concern. Hormone-related symptom scale scores differed by demographic and clinical characteristics according to expectations, suggesting that these five scales from the shortened BCPT checklist are reasonably reliable and valid. Symptom scale scores were only weakly correlated with health-related quality of life scores; however, the pattern of results generally supported the validity of the symptom scales. This study adds to the evidence that breast cancer survivors experience a significant number of hormone-related symptoms. Future clinical trials and quality of life and symptom management intervention studies would benefit from accurate assessment of hormone-related symptoms with the five scales from the shortened BCPT checklist.

The BCPT Symptom Scales: A Measure of Physical Symptoms for Women Diagnosed With or at Risk for Breast Cancer

Documentation of concurrent and late side effects of medical interventions to prevent and treat breast cancer is important in research and clinical practice. We used the Breast Cancer Prevention Trial (BCPT) Symptom Checklist to develop an instrument (BCPT Symptom Scales) that could be used to assess side effects and to examine correlates of the derived symptom dimensions among patient populations. Exploratory and confirmatory factor analyses were conducted using data from the 42-item BCPT Symptom Checklist completed by four distinct patient populations (N = 2208) who had previously been diagnosed with breast cancer or were at risk for the disease. We examined associations among the resulting BCPT Symptom Scales and demographic and cancer-related variables and a widely used measure of health-related quality of life. Exploratory and confirmatory factor analyses revealed eight factors corresponding to physical symptoms associated with cancer treatment, chemoprevention, menopause, and normal aging: hot flashes, nausea, bladder control, vaginal problems, musculoskeletal pain, cognitive problems, weight problems, and arm problems. On the derived BCPT Symptom Scales, women reported somewhat higher mean scores on scales for hot flashes, pain, and weight problems than on scales for the other symptoms. Demographic and cancer-related variables accounted for up to 15% of the interindividual variance in how women responded to the symptom scales. The most consistent predictors of reporting greater symptoms included lower education level and previous receipt of chemotherapy. Meaningful symptom dimensions, identified across four samples of women, were associated with demographic and breast cancer-related variables. The BCPT Symptom Scales offer a valuable refinement of the original BCPT Symptom Checklist to assess side effects associated with the treatment and prevention of breast cancer.

Fatigue in breast cancer survivors: occurrence, correlates, and impact on quality of life.

To describe the occurrence of fatigue in a large sample of breast cancer survivors relative to general population norms and to identify demographic, medical, and psychosocial characteristics of fatigued survivors. Breast cancer survivors in two large metropolitan areas completed standardized questionnaires as part of a survey study, including the RAND 36-item Health Survey, Center for Epidemiological Studies-Depression Scale, Breast Cancer Prevention Trial Symptom Checklist, Medical Outcomes Study Sleep Scale, and demographic and treatment-related measures. On average, the level of fatigue reported by the breast cancer survivors surveyed (N = 1,957) was comparable to that of age-matched women in the general population, although the breast cancer survivors were somewhat more fatigued than a more demographically similar reference group. Approximately one third of the breast cancer survivors assessed reported more severe fatigue, which was associated with significantly higher levels of depression, pain, and sleep disturbance. In addition, fatigued women were more bothered by menopausal symptoms and were somewhat more likely to have received chemotherapy (with or without radiation therapy) than nonfatigued women. In multivariate analyses, depression and pain emerged as the strongest predictors of fatigue. Although the majority of breast cancer survivors in this large and diverse sample did not experience heightened levels of fatigue relative to women in the general population, there was a subgroup of survivors who did report more severe and persistent fatigue. We identified characteristics of these women that may be helpful in elucidating the mechanisms underlying fatigue in this population, as well as directing intervention efforts.

Life after breast cancer: understanding women's health-related quality of life and sexual functioning.

To describe the health-related quality of life (HRQL), partner relationships, sexual functioning, and body image concerns of breast cancer survivors (BCS) in relation to age, menopausal status, and type of cancer treatment. A cross-sectional sample of BCS in two large metropolitan areas was invited to participate in a survey study that included the following standardized measures: the RAND 36-Item Health Survey; the Centers for Epidemiologic Studies-Depression Scale (CES-D); the Dyadic Adjustment Scale (DAS); the Breast Cancer Prevention Trial (BCPT) Symptom Checklist; the Watts Sexual Functioning Questionnaire (WSFQ); and subscales from the Cancer Rehabilitation Evaluation System (CARES). Eight hundred sixty-four BCS completed the survey. RAND Health Survey scores were as good or better than those of healthy, age-matched women, and the frequency of depression was similar to general population samples. Marital/partner adjustment was similar to normal healthy samples, and sexual functioning mirrored that of healthy, age-matched postmenopausal women. However, these BCS reported higher rates of physical symptoms (eg, joint pains, headaches, and hot flashes) than healthy women. Sexual dysfunction occurred more frequently in women who had received chemotherapy (all ages), and in younger women who were no longer menstruating. In women > or = 50 years, tamoxifen therapy was unrelated to sexual functioning. BCS report more frequent physical and menopausal symptoms than healthy women, yet report HRQL and sexual functioning comparable to that of healthy, age-matched women. Nevertheless, some survivors still experience poorer functioning, and clinicians should inquire about common symptoms to provide symptomatic management or counseling for these women.