Feasibility and Acceptability of a Physical Activity Tracker and Text Messages to Promote Physical Activity During Chemotherapy for Colorectal Cancer: Pilot Randomized Controlled Trial (Smart Pace II)

Abstract

Background We conducted a pilot 2-arm randomized controlled trial to assess the feasibility of a digital health intervention to increase moderate-to-vigorous physical activity in patients with colorectal cancer (CRC) during chemotherapy. Objective This study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC. Methods Potentially eligible patients with CRC expected to receive at least 12 weeks of chemotherapy were identified in person at the University of California, San Francisco, and on the web through advertising. Eligible patients were randomized 1:1 to a 12-week intervention (Fitbit Flex, automated SMS text messages) versus usual care. At 0 and 12 weeks, patients wore an Actigraph GT3X+ accelerometer for 7 days and completed surveys, body size measurements, and an optional 6-minute walk test. Participants could not be masked to their intervention arm, but people assessing the body size and 6-minute walk test outcomes were masked. The primary outcomes were adherence (eg, Fitbit wear and text response rate) and self-assessed acceptability of the intervention. The intervention would be considered feasible if we observed at least 80% complete follow-up and 70% adherence and satisfaction, a priori. Results From 2018 to 2020, we screened 240 patients; 53.3% (128/240) of patients were ineligible and 26.7% (64/240) declined to participate. A total of 44 patients (44/240, 18%) were randomized to the intervention (n=22) or control (n=22) groups. Of these, 57% (25/44) were women; 68% (30/44) identified as White and 25% (11/44) identified as Asian American or Pacific Islander; and 77% (34/44) had a 4-year college degree. The median age at enrollment was 54 years (IQR 45-62 years). Follow-up at 12 weeks was 91% (40/44) complete. In the intervention arm, patients wore Fitbit devices on a median of 67 out of 84 (80%) study days and responded to a median of 17 out of 27 (63%) questions sent via SMS text message. Among 19 out of 22 (86%) intervention patients who completed the feedback survey, 89% (17/19) were satisfied with the Fitbit device; 63% (12/19) were satisfied with the SMS text messages; 68% (13/19) said the SMS text messages motivated them to exercise; 74% (14/19) said the frequency of SMS text messages (1-3 days) was ideal; and 79% (15/19) said that receiving SMS text messages in the morning and evening was ideal. Conclusions This pilot study demonstrated that many people receiving chemotherapy for CRC are interested in participating in digital health physical activity interventions. Fitbit adherence was high; however, participants indicated a desire for more tailored SMS text message content. Studies with more socioeconomically diverse patients with CRC are required. Trial Registration ClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716

A Scoping Review to Assess Adherence to and Clinical Outcomes of Wearable Devices in the Cancer Population

“…Only four studies conducted personal interviews to analyze participants’ adherence to WDs and their study experiences [ 21 , 33 , 40 , 57 ]. Furthermore, 10 studies evaluated the correlation between the outcomes of WDs and questionnaires to validate the effectiveness of using WDs in patients with cancer [ 27 , 31 , 34 , 36 , 37 , 48 , 49 , 52 , 54 , 56 ]. Only two studies used an e-diary and a physical diary along with a WD to track the health status of the participants [ 31 , 36 ].…”

“…The average adherence percentage was calculated for each segment. The intervention-based segments included studies with weeks 1 [ 48 , 49 ], 2 [ 27 , 55 ], 3 [ 50 , 52 , 57 ], 4 [ 36 , 37 , 53 ], 7 [ 28 ], 8 [ 32 , 33 , 34 ], 10 [ 24 , 30 , 41 ], 12 [ 20 , 21 , 23 , 25 , 26 , 38 , 39 , 40 , 42 , 43 , 44 , 45 , 46 , 47 , 54 , 56 ], 17 [ 29 ], 24 [ 22 , 31 ] and 43 [ 35 ]. In the graph, (1.84) indicates the studies grouped in this segment that had a one-week intervention with an average adherence of 84%.…”

“…Most of the studies in this review evaluated the feasibility of and adherence to WDs. Of the 38 studies, only 10 determined the correlation between patient-reported and objective outcomes; these studies reported that the use of WDs significantly improved clinical outcomes [ 27 , 31 , 34 , 36 , 37 , 48 , 49 , 52 , 54 , 56 ]. In addition, other studies demonstrated significant improvements in clinical outcomes; however, these studies did not observe a correlation between patient-reported and clinical outcomes.…”

The Use of Wearable Devices in Oncology Patients: A Systematic Review

“…Additionally, feasibility studies generally noted positive experience/satisfaction using wearable devices, citing ease of use, comfort, usefulness, and no interference with daily activity related to Fitbits, ActivPal, and Biovotion AG devices. 34 , 47 , 54 , 60 , 67 , 104 , 129 , 170 , 187 , 197 However, one study by Finley et al noted considerable frustrations with its bulk/comfort and ease of use related to the Garmin Vivoactive HR device. 49 While it is important for the adoption of wearable device to address such potential concerns, its generally high adherence and acceptability, in conjunction with the added benefits of objective, continuous data collection in free-living settings, provide strong support that wearable devices can be readily and effectively integrated into cancer care.…”

Measuring What Is Meaningful in Cancer Cachexia Clinical Trials: A Path Forward With Digital Measures of Real-World Physical Behavior

“… 38 Thus far, DHTs have demonstrated feasibility and acceptability for monitoring patients with cancer during treatment. 37 , 39 , 111 , 112 and have been used in assessing treatment effects and benefits. 113 As such, DHTs hold promise in patient-centered drug development, particularly in studying the impact of treatments on physical function, a primary focus in drug trials and multimodal interventional trials for cachexia.…”