Clinical trial NCT02966054: Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
Official title: Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectum Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Physical activity
timeFrame: 12-weeks
Secondary outcomes:
measure: Fitbit wear time (# days with data / # days of observation)
timeFrame: 12-weeks
measure: Response to text messages (# of messages responded to / # of messages that asked for a response)
timeFrame: 12-weeks
measure: Quality-of-life (SF--36)
timeFrame: 12-weeks
measure: Colorectal cancer-specific quality-of-life (FACT-C)
timeFrame: 12-weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Erin Van Blarigan, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.