Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYA… (NCT05375162) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)
United States304 participantsStarted 2023-07-18
Plain-language summary
The purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden.
PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks
SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality
THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) of the four intervention components on MVPA.
Who can participate
Age range
18 Years – 39 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:
For YACS
* Diagnosis of nonmetastatic cancer (except non-melanoma skin cancer) within 5 years from the time of screening / study overview session
* Age Diagnosis of cancer between 18-39 years at time of diagnosis and at time of screening / study overview session
* Three or more months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
* Score of 0 on two of the Exercise Preparticipation Health Screening Questionnaire items or willingness to obtain medical clearance from a primary care physician or oncologist
* Self-report engagement in \<60 minutes total each week of MVPA at time of screening / study overview session
* Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater)
* Internet access
* Fluency in spoken and written English
* Willingness, at time of screening / study overview session, to find a Buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 6-month study), if assigned to that condition
For "Buddies"
* Friend, co-worker, caregiver or family member of a participating YACS
* Age 18 years or older
* Score of 0 on the Exercise Preparticipation Health Screening Questionnaire or willingness to obtain medical clearance from a primary care physician
* Ownership of a smartphone that is either an iPhone (version 5 or gre…
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.
What they're measuring
1
Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors