An interventional study of Fitbit and Text Messages in Colorectal Cancer, Colon Cancer and Rectal Cancer, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-27.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
There is a critical need for physical activity interventions in colorectal cancer (CRC). The investigators have developed a digital health physical activity intervention, Smart Pace, which includes a wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. In this study, the investigators propose to expand and improve Smart Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the feasibility of this novel digital health physical activity intervention among 48 CRC patients on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 44 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Exclusion Criteria:
Participants randomized to this arm receive print materials and a Fitbit Flex 2 at baseline and daily text messages for 12 weeks.
Behavioral: Fitbit and Text Messages
Participants randomized to usual care receive print materials at baseline.
Physical activity tracker wristband and daily text messages delivered to the participants' phones.
Fitbit wear time
Number of study days Fitbit is worn
Time frame: up to 12 weeks from study start
Acceptability of the intervention
Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm.
Time frame: At 12 weeks from study start
Text message response rate
Time frame: up to 12 weeks from study start
Objective physical activity
Minutes of moderate-to-vigorous physical activity per week measured by accelerometer
Time frame: At 0 weeks and 12 weeks from study start
Fatigue
Lee Fatigue Scale
Time frame: At 0 and 12 weeks from study start
Cardiorespiratory fitness
6 minute walk test
Time frame: At 0 and 12 weeks from study start
Anthropometrics, Waist circumference
Time frame: At 0 and 12 weeks from study start
Anthropometrics, Body weight
Time frame: At 0 and 12 weeks from study start
Sleep quality
Will be assessed by the Pittsburgh Sleep Quality Index, providing a score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time frame: At 0 and 12 weeks from study start
Health-related quality of life in cancer patients
Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 30
Time frame: At 0 and 12 weeks from study start
Health-related quality of life in colorectal cancer patients
Will be assessed via the European Organization for Research and Treatment (EORTC) of Cancer Quality of Life Questionnaire-Core 29
Time frame: At 0 and 12 weeks from study start
Neuropathy
Will be assessed by the Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) questionnaire, a 20-item quality of life questionnaire.
Time frame: At 0 and 12 weeks from study start
Anxiety
Will be assessed by the Spielberger State-Trait Anxiety Inventories (STAI), consisting of 40 questions on a self-report basis. Scores range from 20 to 80, with higher scores correlating with greater anxiety.
Time frame: At 0 and 12 weeks from study start
Depression
Will be assessed by the Center for Epidemiological Studies-Depression Scale (CES-D), a brief self-report questionnaire which consists of 20 questions. Scores on the CES-D range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms.
Time frame: At 0 and 12 weeks from study start
Leisure-time physical activity
Will be assessed via the Harvard Health Professionals Follow-up Study (HPFS) physical activity questionnaire.
Time frame: At 0 and 12 weeks from study start
Perceived barriers to physical activity
Modified from the Project Graduate Ready for Activity Daily(GRAD) survey - 24 items plus a write-in option.
Time frame: At 0 and 12 weeks from study start
Exercise Confidence
Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 11 items.
Time frame: At 0 and 12 weeks from study start
Social support
Modified from the Project GRAD (Graduate Ready for Activity Daily) survey - 13 items asked about social support.
Time frame: At 0 and 12 weeks from study start
Plan to share: No — Results from this pilot clinical trial will be reported at national conferences and published in peer-review journals.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco