- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05450315
Targeted Vs Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors
July 7, 2022 updated by: University of Alberta
Effects of Targeted Versus Generic Print Materials on Physical Activity and Quality of Life in Young Adult Cancer Survivors: A Randomized Control Trial
Young adult cancer survivors (YACS) are an understudied group in cancer survivorship research that have unique psychosocial, medical and survivorship issues.
Physical activity (PA) has important effects on health-related outcomes in middle-aged and older cancer survivors and preliminary research suggests similar benefits in YACS (18-39 years).
Unfortunately, only about half of YACS report meeting public health PA guidelines and there are no interventions or resources available to help YACS increase their PA.
The purpose of this study is to test a physical activity guidebook that was developed for YACS based on the theory of planned behavior (TPB).
The PA guidebook will be evaluated in a randomized controlled trial.
Specifically, 300 YACS will be randomly assigned to (a) Canada's PA guidelines for adults or (b) the YACS PA guidebook.
YACS will complete assessments of PA, quality of life, and psychosocial variables at baseline (prior to randomization), 1 month, and 3 months.
The primary endpoint in the trial will be change in self-reported PA minutes from baseline to 3 months.
Secondary endpoints will include changes in TPB constructs and quality of life.
It is hypothesized that the group receiving the YACS PA guidebook (TARG) will report a greater increase in PA minutes compared to the group receiving Canada's PA guidelines (CPAG).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
212
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2H9
- Behaviour Medicine Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed with cancer in Alberta, Canada
- Still living in Alberta, Canada
- Read English
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TARG
Group will receive physical activity information targeted to young adult cancer survivors
|
|
|
Active Comparator: CPAG
Group will receive the Canadian Public Health Guidelines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of Targeted Versus Generic Print Materials
Time Frame: One Year
|
Behaviour Change
|
One Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 26, 2015
First Submitted That Met QC Criteria
July 7, 2022
First Posted (Actual)
July 8, 2022
Study Record Updates
Last Update Posted (Actual)
July 8, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- S2Survive
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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