Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for AYAO (OPT2MOVE)
Running, not enrolling · Not applicable
Conditions studied: Cancer
In brief
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.
Key facts
- Study ID
- NCT05375162
- Run by
- Northwestern University
- People needed
- 304
- Starts
- 2023-07-18
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older, up to 39. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 greater) or an Android (version 5.0 or greater)
- Internet access
- Fluency in spoken and written English
- Willingness to share their Fitbit data with the study team
You may not qualify if…
- For YACS: Diagnosis of non-melanoma skin cancer
- Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
- Currently pregnant or plans to become pregnant in the next 12 months
- Plans to move out of the United States in next 18 months
- For YACS: Current enrollment in another dietary or physical activity trial
- Inability to provide informed consent
- Prisoners or other detained individuals
Where it is running
- Northwestern University — Chicago, Illinois, United States
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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