Study Design
The current study involved secondary analyses of potential moderators of treatment efficacy for the BEAT Cancer intervention. Data are taken from the parent physical activity randomized controlled trial (N=222 breast cancer survivors) (10). Potential moderator variables (e.g., demographic, medical, and intervention outcome) were measured at baseline. Treatment response was determined by changes in physical activity and QoL from baseline (M0) to month 3 (M3), as measured by accelerometer monitoring, self-reported moderate-to-vigorous physical activity, and QoL questionnaires. The parent multicenter randomized controlled trial has been registered on clinicaltrials.gov (NCT00929617) and described in detail in a previous report (10, 11, 29).
Participants
Women ages 18-70 years old with a history of ductal carcinoma in situ or stage I-IIIA breast cancer, who self-reported a sedentary lifestyle (engaging in ≤ 30 minutes of vigorous or ≤ 60 minutes of moderate intensity physical activity per week on average over six months) were recruited into the trial. Eligible participants must have completed primary cancer treatment, be ≥ 8 weeks post-surgery, English speaking, and received medical clearance by their physician. Exclusion criteria included conditions that contraindicated physical activity or would interfere with assessments, and current participation in another physical activity study. Additional details regarding inclusion and exclusion criteria were reported by Rogers et al. (29) Institutional review board (IRB) approval was obtained, and all participants provided written informed consent.
Better Exercise Adherence after Treatment for Cancer (BEAT Cancer) Intervention
The 3-month social cognitive theory-based BEAT Cancer intervention included 12 supervised individual exercise sessions tapered over six weeks, followed by independent home-based exercise sessions with three face-to-face exercise counseling sessions every two weeks with an exercise specialist. Additionally, during the first 8 weeks, six group sessions led by trained facilitators provided behavioral counseling (e.g., time management, stress management, behavioral modification strategies etc.). The goal of the exercise prescription was to gradually progress participants to 150 weekly minutes of moderate intensity physical activity, although participants were advanced to higher intensity if interested and able. An educational notebook and heart rate monitor were also provided to participants. A detailed description of the BEAT Cancer intervention was provided in prior publications (10, 11, 29).
Usual Care (UC) Intervention
The UC group received written materials from the American Cancer Society describing physical activity recommendations for cancer survivors (see Rogers et al. (29) for additional details regarding the UC group intervention).
Measures
Measurements were taken at baseline (M0), immediately post-intervention (M3) and 3 months after intervention completion (M6). Assessment and data entry staff were blinded to study group allocation.
Physical Activity
Physical activity was measured by 7-day accelerometer monitoring (MTI/ActiGraph; model numbers GT1M and GT3X). Participants received the same accelerometer for all assessments. Participants were given an exercise log and instructions to wear the motion sensor during waking hours for seven consecutive days, apart from bathing and swimming. Participants were asked to perform their usual activities within the seven consecutive days. Activity counts were used to determine activity durations (minutes/day) in specific intensity levels with a focus on moderate [1952–5724 counts/min] and vigorous [5725+counts/min]) (30, 31). Additionally, self-reported physical activity was obtained using a modified version of the Godin Leisure Time Exercise Questionnaire (32, 33). Self-reported activity duration was multiplied by frequency to determine minutes per week spent in each of the three activity levels: light, moderate, vigorous. For accelerometer and self-report physical activity, vigorous minutes were doubled before adding to moderate minutes when calculating moderate-to-vigorous physical activity (MVPA).
Quality Of Life
Quality of life was measured using the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) (34). The 37-item FACT-Breast questionnaire includes the subscales of physical well-being, social well-being, emotional well-being, functional well-being, and additional concerns (34). The sums of the Likert scale items were calculated for each subscale and also for FACT-Breast (sum of all subscales combined), FACT-General (sum of all subscales except for additional concerns), and Trial Outcome Index (sum of physical well- being, functional well-being, and breast additional concerns subscales) (35). Higher scores represent better QoL.
Moderators
Potential moderator variables were identified from the literature and selected based on relevance and plausibility for the breast cancer population and included demographic (age (16, 20, 21), marital status (17, 19), annual income, education (19), race, and rural residence), medical (BMI (17, 22), co-morbidities (17), breast cancer stage (16), history of chemotherapy (19, 20), history of radiation (19), hormone therapy (36), time since diagnosis (15)) and intervention outcome (baseline value of the outcome (20), joint function (WOMAC) (20)) related factors. Demographic moderators (e.g., age, marital status, annual income, and rurality) were assessed with a demographics questionnaire, rurality was determined by using the United States Department of Agriculture Rural-Urban Continuum Codes (i.e., RUCC, analyzed as continuous variable) (37). A medical history questionnaire was used to assess cancer-related factors; time since diagnosis, treatment history, and inquire if any doctor had advised physical activity since their breast cancer diagnosis (yes, no, or I do not know as possible responses). Participants also completed the Comorbidity Index to quantify the number of comorbid conditions (38) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) to assess lower extremity pain (5 items), stiffness (2 items), and physical dysfunction (17 items) using a 5-point Likert scale (i.e., 1 = none to 5 = extreme) (39). Finally, BMI was assessed via anthropometric measurements obtained from a scale and stadiometer (Continental Health-O-Meter #400 DML medical and Seca 763 Digital Column Scale). BMI was calculated from the height and weight [weight (kg)/height (m2)].
Statistical Analysis
We used intent-to-treat and adjusted linear mixed model ANOVA with interaction terms analyses to assess the intervention effect on MVPA, and QoL from immediately post-intervention (M3) and 3 months after intervention completion (M6), by each hypothesized moderator. Moderators were dichotomized and grouped as follows: age (<55 vs. ≥55), marital status (married or living with significant other vs. other), annual income (<$50,000 vs. ≥$50,000), education (≤high school degree or equivalent vs. >high school degree), rurality (RUCC Code 1,3,6), BMI (<30 vs. ≥30), co-morbidities (median Comorbidity Index score used as cutpoint), cancer stage (DCIS or stage I vs. stage II or III), time on hormonal therapy (none vs. ≤1 year vs. >1 year), months since diagnosis (≤12 vs. >12), baseline value of the outcome (median scores used as cutpoint), and WOMAC (median score used as cutpoint). The change over time across the intervention–moderator interaction term was modeled.
All models adjusted for previously identified covariates including baseline value of the outcome, study site, marital status, breast cancer stage, history of chemotherapy, history of radiation therapy, hormone therapy treatment and comorbidities (10). Statistical analyses were performed using SAS® statistical software (Cary, NC). Statistical significance was defined as p < 0.05.