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

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ClinicalTrials.gov Identifier: NCT02966054
Recruitment Status : Completed
First Posted : November 17, 2016
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Erin Van Blarigan, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE November 9, 2016
First Posted Date  ICMJE November 17, 2016
Last Update Posted Date April 9, 2018
Study Start Date  ICMJE August 2014
Actual Primary Completion Date June 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
Physical activity [ Time Frame: 12-weeks ]
Change in total physical activity assessed via ActiGraph GT3X+ accelerometers
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • Fitbit wear time (# days with data / # days of observation) [ Time Frame: 12-weeks ]
  • Response to text messages (# of messages responded to / # of messages that asked for a response) [ Time Frame: 12-weeks ]
  • Quality-of-life (SF--36) [ Time Frame: 12-weeks ]
  • Colorectal cancer-specific quality-of-life (FACT-C) [ Time Frame: 12-weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
Official Title  ICMJE Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Colon Cancer
  • Rectum Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Intervention
    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.
    Intervention: Behavioral: Digital Health Physical Activity Intervention Group
  • No Intervention: Control
    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".
Publications * Van Blarigan EL, Chan H, Van Loon K, Kenfield SA, Chan JM, Mitchell E, Zhang L, Paciorek A, Joseph G, Laffan A, Atreya CE, Fukuoka Y, Miaskowski C, Meyerhardt JA, Venook AP. Self-monitoring and reminder text messages to increase physical activity in colorectal cancer survivors (Smart Pace): a pilot randomized controlled trial. BMC Cancer. 2019 Mar 11;19(1):218. doi: 10.1186/s12885-019-5427-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
42
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2016)
40
Actual Study Completion Date  ICMJE June 20, 2017
Actual Primary Completion Date June 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02966054
Other Study ID Numbers  ICMJE 14-14452
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erin Van Blarigan, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erin Van Blarigan, ScD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP