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

Not Applicable

Completed

• Conditions: Rectum Cancer; Colon Cancer
• Interventions: Behavioral: Digital Health Physical Activity Intervention Group

• Registration Number: NCT02966054
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Primary Completion: 2017-06-20
• Study Completion: 2017-06-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Digital Health Physical Activity Intervention Group	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.

Primary Outcome Measures

Name	Time	Method
Physical activity	12-weeks	Change in total physical activity assessed via ActiGraph GT3X+ accelerometers

Secondary Outcome Measures

Name	Time	Method
Colorectal cancer-specific quality-of-life (FACT-C)	12-weeks
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States