Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial

Study Overview
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Brief Summary
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Epidemiologic data consistently indicate that colorectal cancer survivors can improve their quality-of-life and prognosis by engaging in physical activity. This study aims to build on this epidemiologic work and translate the findings to inform and change patient behavior. The specific aims are to: (1) Develop a mobile technology physical activity intervention among colorectal cancer patients who have completed therapy. (2) Conduct a 3-month pilot randomized controlled trial utilizing mobile technology to increase physical activity among 40 men and women who have completed standard cytotoxic chemotherapy for primary stage I-III colorectal cancer at the UCSF Helen Diller Family Comprehensive Cancer Center. Participants in the intervention arm will receive a Fitbit® for self-monitoring, interactive text messages, and educational print materials; participants in the control arm will receive educational print materials at baseline and will be given a Fitbit® after completion of the 3-mo. follow-up assessment.

Official Title
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Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial

Conditions
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Colon Cancer, Rectum Cancer

Intervention / Treatment
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* Behavioral: Digital Health Physical Activity Intervention Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stage I-III colon or rectal adenocarcinoma completed standard cytotoxic chemotherapy if medically indicated be considered disease-free at baseline be able to speak and read English have no contra-indication to moderate to vigorous aerobic exercise be able to walk unassisted be inactive at baseline (<150 min/week of moderate physical activity) have access to a mobile phone be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will be provided with a booklet from the UCSF Dept. of Physical Therapy and Rehabilitation Science: Moving Through Cancer: A Guide to Exercise for Cancer Survivors. The intervention group will be given a Fitbit® Flex to wear throughout the study and will receive daily text messages to support increased physical activity. | Behavioral: Digital Health Physical Activity Intervention Group<br>* Print materials on exercise after cancer, Fitbit Flex for 12 weeks, and daily Text Messages for 12 weeks<br>|
| No Intervention: Control<br>Patients in the control arm will be provided with a booklet at baseline from the UCSF Dept. of Physical Therapy and Rehabilitation Science: Moving Through Cancer: A Guide to Exercise for Cancer Survivors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Change in total physical activity assessed via ActiGraph GT3X+ accelerometers | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitbit wear time (# days with data / # days of observation) |  | 12-weeks | 
| Response to text messages (# of messages responded to / # of messages that asked for a response) |  | 12-weeks | 
| Quality-of-life (SF--36) |  | 12-weeks | 
| Colorectal cancer-specific quality-of-life (FACT-C) |  | 12-weeks |