Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial.

BACKGROUND: Moderate to vigorous physical activity (MVPA) interventions improve patient-reported outcomes (PROs) of physical and psychological health among breast cancer survivors (BCS); however, the effects of specific intervention components on PROs are unknown. PURPOSE: To use the Multiphase Optimization Strategy (MOST) to examine overall effects of the Fit2Thrive MVPA promotion intervention on PROs in BCS and explore whether there are intervention component-specific effects on PROs. METHODS: Physically inactive BCS [n = 269; Mage = 52.5 (SD = 9.9)] received a core intervention (Fitbit + Fit2Thrive smartphone app) and were randomly assigned to one of 32 conditions in a full factorial experiment of five components ("on" vs. "off"): (i) support calls, (ii) deluxe app, (iii) text messages, (iv) online gym, and (v) buddy. Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires assessed anxiety, depression, fatigue, physical functioning, sleep disturbance and sleep-related impairment at baseline, post-intervention (12-week), and 24-week follow-up. Main effects for all components at each time point were examined using an intention to treat mixed-effects model. RESULTS: All PROMIS measures except sleep disturbance significantly improved (p's < .008 for all) from baseline to 12-weeks. Effects were maintained at 24-weeks. The "on" level of each component did not result in significantly greater improvements on any PROMIS measure compared to the "off" level. CONCLUSIONS: Participation in Fit2Thrive was associated with improved PROs in BCS, but improvements did not differ for "on" vs. "off" levels for any component tested. The low-resource Fit2Thrive core intervention is a potential strategy to improve PROs among BCS. Future studies should test the core in an RCT and examine various intervention component effects in BCS with clinically elevated PROs.

A multi-site trial of an electronic health integrated physical activity promotion intervention in breast and endometrial cancers survivors: MyActivity study protocol.

Despite the known benefits of moderate-to-vigorous physical activity (MVPA) for breast and endometrial cancer survivors, most are insufficiently active, interventions response is heterogeneous, and MVPA programming integration into cancer care is limited. A stepped care approach, in which the least resource-intensive intervention is delivered first and additional components are added based on individual response, is one strategy to enhance uptake of physical activity programming. However, the most effective intervention augmentation strategies are unknown. In this singly randomized trial of post-treatment, inactive breast and endometrial cancer survivors (n = 323), participants receive a minimal intervention including a Fitbit linked with their clinic's patient portal and, in turn, the electronic health record (EHR) with weekly feedback delivered via the portal. MVPA progress summaries are sent to participants' oncology team via the EHR. MVPA adherence is evaluated at 4, 8, 12, 16 and 20 weeks; non-responders (those meeting ≤80% of the MVPA goal over previous 4 weeks) at each timepoint are randomized once for the remainder of the 24-week intervention to one of two "step-up" conditions: (1) online gym or (2) coaching calls, while responders continue with the minimal Fitbit+EHR intervention. The primary outcome is ActiGraph-measured MVPA at 24 and 48 weeks. Secondary outcomes include symptom burden and functional performance at 24 and 48 weeks. This trial will inform development of an effective, scalable, and tailored intervention for survivors by identifying non-responders and providing them with the intervention augmentations necessary to increase MVPA and improve health outcomes. Clinical Trials Registration # NCT04262180.

Longitudinal Sedentary Time and Symptoms in Breast Cancer Patients during Chemotherapy Using Ecological Momentary Assessment.

PURPOSE: To examine the relationship between daily fluctuations in symptoms and sedentary behavior (SB) during chemotherapy (CT) for breast cancer. METHODS: Breast cancer patients ( N = 68, M age = 48.5 ± 10.4 yr) undergoing CT wore an activity monitor on their hip to assess daily SB and completed prompts assessing symptoms (affect, anxiety, depression, fatigue, pain, and physical and cognitive functioning) for 10 consecutive days (3 d pre-CT, day of, and 6 d post-CT) at the beginning, middle and end cycles of CT. Mixed models assessed the bidirectional between-person (BP) and within-person (WP) associations of current day symptoms with minutes of SB measured on 1) the same day and 2) the next day, controlling for relevant covariates. RESULTS: Within person same-day results revealed a significant association between affect, anxiety, fatigue, physical functioning, pain, and cognitive functioning and same-day SB. Worse than average symptom ratings on a given day were associated with more SB that day. There was a significant WP relationship between previous-day anxiety, depression, and physical function and next-day SB (i.e., worse than average symptom ratings the previous day were associated with more SB the next day). Within person same-day results revealed a significant association between same-day SB and affect, anxiety, fatigue, pain, physical functioning, and cognitive functioning. The WP relationships were significant for previous-day SB and next-day affect and pain (i.e., higher than average SB associated with lower ratings). Relationships persisted when controlling for moderate-to-vigorous physical activity. There were no significant BP results. CONCLUSIONS: Higher symptom ratings were associated with increased SB and higher SB was associated with worse symptoms. Future work should identify SB reduction intervention approaches tailoring to daily symptom burden during CT for breast cancer.