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

Primary Purpose

Colon Cancer, Rectum Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Health Physical Activity Intervention Group
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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".

Outcomes

Primary Outcome Measures

Physical activity
Change in total physical activity assessed via ActiGraph GT3X+ accelerometers

Secondary Outcome Measures

Fitbit wear time (# days with data / # days of observation)
Response to text messages (# of messages responded to / # of messages that asked for a response)
Quality-of-life (SF--36)
Colorectal cancer-specific quality-of-life (FACT-C)

Full Information

First Posted
November 9, 2016
Last Updated
April 5, 2018
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02966054
Brief Title
Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
Acronym
Smart Pace
Official Title
Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
June 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectum Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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".
Intervention Type
Behavioral
Intervention Name(s)
Digital Health Physical Activity Intervention Group
Intervention Description
Print materials on exercise after cancer, Fitbit Flex for 12 weeks, and daily Text Messages for 12 weeks
Primary Outcome Measure Information:
Title
Physical activity
Description
Change in total physical activity assessed via ActiGraph GT3X+ accelerometers
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Fitbit wear time (# days with data / # days of observation)
Time Frame
12-weeks
Title
Response to text messages (# of messages responded to / # of messages that asked for a response)
Time Frame
12-weeks
Title
Quality-of-life (SF--36)
Time Frame
12-weeks
Title
Colorectal cancer-specific quality-of-life (FACT-C)
Time Frame
12-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Van Blarigan, ScD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35119520
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.
Results Reference
derived
PubMed Identifier
30866859
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.
Results Reference
derived

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

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