Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
Smart Pace
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 9, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2017
CompletedApril 9, 2018
April 1, 2018
2.9 years
November 9, 2016
April 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Physical activity
Change in total physical activity assessed via ActiGraph GT3X+ accelerometers
12-weeks
Secondary Outcomes (4)
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
Colorectal cancer-specific quality-of-life (FACT-C)
12-weeks
Study Arms (2)
Intervention
EXPERIMENTALPatients 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.
Control
NO INTERVENTIONPatients 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".
Interventions
Print materials on exercise after cancer, Fitbit Flex for 12 weeks, and daily Text Messages for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94158, United States
Related Publications (2)
Chan H, Van Loon K, Kenfield SA, Chan JM, Mitchell E, Zhang L, Paciorek A, Joseph G, Laffan A, Atreya C, Fukuoka Y, Miaskowski C, Meyerhardt JA, Venook AP, Van Blarigan EL. Quality of life of colorectal cancer survivors participating in a pilot randomized controlled trial of physical activity trackers and daily text messages. Support Care Cancer. 2022 May;30(5):4557-4564. doi: 10.1007/s00520-022-06870-5. Epub 2022 Feb 4.
PMID: 35119520DERIVEDVan 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.
PMID: 30866859DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Van Blarigan, ScD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 9, 2016
First Posted
November 17, 2016
Study Start
August 1, 2014
Primary Completion
June 20, 2017
Study Completion
June 20, 2017
Last Updated
April 9, 2018
Record last verified: 2018-04