A pilot randomized controlled trial of a digital health intervention to increase physical activity during chemotherapy for colorectal cancer: feasibility and acceptability

Authors: Van Blarigan EL, Dhruva A, Atreya CE, Kenfield SA, Chan JM, Milloy A, Kim I, Steiding P, Laffan A, Zhang L, Piawah S, Miaskowski C, Hecht F, Venook AP, Van Loon K

Category: Behavioral Science & Health Communication
Conference Year: 2021

Abstract Body:
Purpose: We conducted a pilot randomized controlled trial of a digital health intervention to increase moderate to vigorous physical activity (MVPA) among CRC patients during chemotherapy. Methods: Eligible patients were expected to receive ≥12 wks of chemotherapy; had provider approval of unsupervised MVPA; English proficient; able to receive email/text messages; and self-reported of <150 min/wk MVPA. Patients were randomized 1:1 to a 12-wk intervention (Fitbit Flex, text messages) vs. usual care. At 0- and 12-wks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-min walk test. Here we report the primary outcomes: adherence (e.g., Fitbit wear, text response rate) and acceptability of the intervention. A priori, the intervention would be considered feasible if we observed ≥80% complete follow-up and ≥70% adherence and satisfaction. Results: In 2018 to 2020, we screened 240 patients; 55% were ineligible and 27% declined. Forty-four patients were randomized to intervention (n=22) or control (n=22). These patients were 57% female; 71% non-Hispanic white; 26% Asian American/Pacific Islander; 64% had colon cancer; 36% had rectal cancer; 50% had stage III and 39% had stage IV. Mean age and BMI were 54±13 y and 26.2±6.9 kg/m^2. Forty patients completed ≥1 study task at 12 wks (91% follow-up). In the intervention arm, patients wore Fitbits a median of 67 of 84 study days (80%) and responded to a median 13 out of 27 questions sent via text message (48%). Among the 19 of 22 intervention patients who completed the feedback survey, 89% were satisfied with the Fitbit and 63% were satisfied with the text messages; 68% said the text messages motivated them to exercise; 74% said the frequency of text messages (1-3 days) was ideal; 79% said receiving text messages in the morning and evening was ideal. Conclusion: We achieved our a priori goals for retention and Fitbit adherence, but satisfaction and response rates with the text messages was lower than 70%. Participant feedback indicated a desire for more tailored text message content. Studies with more racially/ethnically and socioeconomically diverse CRC patients are also needed. ClinicalTrials.gov Identifier: NCT03524716

Keywords: Fitbit, text messages, behavior, exercise