- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471363
Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity
March 27, 2023 updated by: University of Colorado, Denver
Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity Intervention: A Needs Assessment Study
The goal of this research is to explore cancer survivors' and their romantic partners' interest in a couples-based physical activity intervention and whether cancer-specific exercise education influences exercise beliefs and intentions.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will assess multiple predictors of couples-based physical activity interest among both survivors and partners including gender, age, current exercise, relationship satisfaction and partner support for exercise.
Additionally, this study will include an experimental manipulation in which half of the sample will be randomized to receive cancer-specific exercise education.
Study Type
Observational
Enrollment (Anticipated)
448
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
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
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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 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
We are interested in hearing from cancer survivors and romantic partners from diverse backgrounds.
This study is open to both active and inactive individuals.
Cancer survivors can have had any type of cancer, cancer treatment, or recurrence(s).
Further, we are not limiting participation based on time since diagnosis.
Romantic partners do not need to be married, co-habituating, or in a relationship for a specific time-period in order to be eligible.
Additionally, this study will not exclude couples in which both individuals are cancer survivors.
Lastly, while we prefer both partners within a couple participate, we will not exclude individual participation.
Description
In order to be eligible, individuals must answer "Yes" to all of the following statements:
- I am a cancer survivor OR I am the romantic partner of a cancer survivor
- I am not currently undergoing chemotherapy, radiation or surgery nor do I have plans to undergo chemotherapy, radiation or a cancer-related surgery in the next 6 months
- I am in a committed, romantic relationship
- I have access to a computer or tablet with internet
- I have an email address that I am willing to share with the study team
- I am at least 18 years of age and less than 90 years of age
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
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cancer Specific Exercise Education
This subsample of participants will watch an audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.
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An audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.
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Control
All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire to determine predictors
Time Frame: 45 minutes
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All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions.
Participation in this study will last approximately 45 minutes, and all data will be collected using an on-line Redcap survey.
Predictors to be examined are gender, age, current exercise, relationship satisfaction and partner support for exercise.
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45 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
June 14, 2018
Primary Completion (Actual)
February 8, 2019
Study Completion (Anticipated)
February 8, 2024
Study Registration Dates
First Submitted
July 10, 2020
First Submitted That Met QC Criteria
July 10, 2020
First Posted (Actual)
July 15, 2020
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-1649.cc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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