Van Blarigan Erin L, Dhruva Anand, Atreya Chloe E, Kenfield Stacey A, Chan June M, Milloy Alexandra, Kim Iris, Steiding Paige, Laffan Angela, Zhang Li, Piawah Sorbarikor, Fukuoka Yoshimi, Miaskowski Christine, Hecht Frederick M, Kim Mi-Ok, Venook Alan P, Van Loon Katherine
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States.
Department of Urology, University of California, San Francisco, San Francisco, CA, United States.
JMIR Cancer. 2022 Jan 11;8(1):e31576. doi: 10.2196/31576.
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.
This study aimed to determine whether a digital health physical activity intervention is feasible and acceptable during chemotherapy for CRC.
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.
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.
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.
ClinicalTrials.gov NCT03524716; https://clinicaltrials.gov/ct2/show/NCT03524716.
我们开展了一项双臂随机对照试验的试点研究，以评估数字健康干预措施增加结直肠癌（CRC）患者化疗期间中度至剧烈身体活动的可行性。
本研究旨在确定数字健康身体活动干预措施在CRC患者化疗期间是否可行且可接受。
在加利福尼亚大学旧金山分校亲自招募以及通过网络广告招募预期接受至少12周化疗的潜在合格CRC患者。符合条件的患者按1:1随机分为12周干预组（Fitbit Flex手环、自动短信）和常规护理组。在第0周和第12周时，患者佩戴Actigraph GT3X+加速度计7天，并完成调查问卷、身体尺寸测量以及一项可选的6分钟步行测试。参与者无法对其所在干预组不知情，但评估身体尺寸和6分钟步行测试结果的人员是不知情的。主要结局指标为依从性（如Fitbit手环佩戴情况和短信回复率）以及对干预措施的自我评估可接受性。如果我们观察到至少80%的患者完成随访，且依从性和满意度达到70%，则认为该干预措施可行。
2018年至2020年，我们筛查了240例患者；53.3%（128/240）的患者不符合条件，26.7%（64/240）的患者拒绝参与。共有44例患者（44/240，18%）被随机分为干预组（n = 22）或对照组（n = 22）。其中，57%（25/44）为女性；68%（30/44）为白人，25%（11/44）为亚裔美国人或太平洋岛民；77%（34/44）拥有四年制大学学位。入组时的中位年龄为54岁（四分位间距45 - 62岁）。12周时的随访完成率为91%（40/44）。在干预组中，患者在84天的研究日中平均佩戴Fitbit设备67天（80%），对通过短信发送的27个问题平均回复17个（63%）。在22例完成反馈调查的干预组患者中，19例（86%）表示对Fitbit设备满意；63%（12/19）对短信满意；68%（13/19）表示短信激励他们进行锻炼；74%（14/19）表示短信发送频率（1至3天）理想；79%（15/19）表示早晚收到短信理想。
这项试点研究表明，许多接受CRC化疗的人有兴趣参与数字健康身体活动干预。Fitbit手环的依从性较高；然而，参与者表示希望短信内容更具针对性。需要开展针对社会经济背景更多样化的CRC患者的研究。
ClinicalTrials.gov NCT03524716；https://clinicaltrials.gov/ct2/show/NCT03524716
