Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality … (NCT05075759) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Testing Counseling and Mobile Health Interventions to Improve Physical Activity and Diet Quality in Survivors of Childhood Cancer
United States374 participantsStarted 2022-06-06
Plain-language summary
This clinical trial evaluates several behavioral interventions for the improvement of physical activity in cancer patients. Childhood and adolescent/young adult cancer survivors have been reported to have poor diet quality and rarely meet recommended physical activity guidelines. This trial aims to see whether a tailored intervention based on self-determination theory may help to improve physical activity and dietary change.
Who can participate
Age range
18 Years – 54 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Childhood Cancer Survivor Study (CCSS) participant who is between age 18 to \< 55 years at time of initial approach
* Moderate to high CV risk status based on CCSS risk prediction models for cardiomyopathy and ischemic heart disease
* Able to read, write, and speak English
* Ability to understand and the willingness to provide informed consent
* At least one of the following:
* Less than 30 minutes/day of moderate to vigorous physical activity (MVPA) based on validated self-report instrument (Godin)
* Healthy Eating Index (HEI)-2015 score \< 60 per study food frequency questionnaire (FFQ)
* Body mass index (BMI) \>= 25 kg/m\^2 per self-reported height and weight
* Be free of any known (self-reported) ischemic heart disease or cardiomyopathy
* Have internet access (can be via smartphone or computer; if neither device is available, the study can loan participants a Wi-Fi enabled device, but participant will need to have access to the internet)
Exclusion Criteria:
* Individuals with known cardiomyopathy or ischemic heart disease based on prior CCSS surveys are excluded. While not likely to be common, participants who newly report in our study's screening questionnaire that they have newly diagnosed cardiomyopathy or ischemic heart disease will also be excluded
* Having any self-reported contraindication to walking or being physically active
* Not currently known to be pregnant; individuals known to be pregnant and otherwise eligible for the study …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.