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

Colon Cancer Clinical Trial

— Smart Pace  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966054
• Other study ID #: 14-14452
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: April 5, 2018
• Start date: August 2014
• Est. completion date: June 20, 2017

Study information

• Verified date: April 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 20, 2017
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Neoplasms
• Rectum Cancer

Intervention

Behavioral:
• Digital Health Physical Activity Intervention Group
Print materials on exercise after cancer, Fitbit Flex for 12 weeks, and daily Text Messages for 12 weeks

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Change in total physical activity assessed via ActiGraph GT3X+ accelerometers	12-weeks
Secondary	Fitbit wear time (# days with data / # days of observation)		12-weeks
Secondary	Response to text messages (# of messages responded to / # of messages that asked for a response)		12-weeks
Secondary	Quality-of-life (SF--36)		12-weeks
Secondary	Colorectal cancer-specific quality-of-life (FACT-C)		12-weeks