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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

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectum Cancer Behavioral: Digital Health Physical Activity Intervention Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
Study Start Date : August 2014
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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".



Primary Outcome Measures :
  1. Physical activity [ Time Frame: 12-weeks ]
    Change in total physical activity assessed via ActiGraph GT3X+ accelerometers


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02966054


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Erin Van Blarigan, ScD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erin Van Blarigan, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02966054     History of Changes
Other Study ID Numbers: 14-14452
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases