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OpenTrials
Completed

NCT Number: NCT02966054

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Health Physical Activity Intervention Group

Behavioral

Print materials on exercise after cancer, Fitbit Flex for 12 weeks, and daily Text Messages for 12 weeks

Primary outcomes

  1. Physical activity

    Time frame: 12-weeks

    Change in total physical activity assessed via ActiGraph GT3X+ accelerometers

Secondary outcomes

  1. Fitbit wear time (# days with data / # days of observation)

    Time frame: 12-weeks

  2. Response to text messages (# of messages responded to / # of messages that asked for a response)

    Time frame: 12-weeks

  3. Quality-of-life (SF--36)

    Time frame: 12-weeks

  4. Colorectal cancer-specific quality-of-life (FACT-C)

    Time frame: 12-weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: Smart Pace

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 17, 2016
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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