Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Canc… (NCT05931874) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
United States304 participantsStarted 2024-03-24
Plain-language summary
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
Who can participate
Age range
18 Years
Sex
FEMALE
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 BCS
* Female, age 18 years or older
* Stage I-III breast cancer diagnosis within the past 5 years
* Diagnosis of cancer between 18-39 years and within the past 5 years
* ≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
* Self-report engagement in \<60 min/week of MVPA
* Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willingness to obtain medical clearance from a primary care physician or oncologist
* Internet access and smartphone ownership
* Fluency in spoken and written English
* Willingness 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 24-week study), if assigned to that condition
For "Buddies"
* Friend, co-worker, caregiver or family member of a participating BCS
* Age 18 years or older
* Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willing to obtain medical clearance from a primary care physician
* Internet access and smartphone ownership
* Fluency in spoken and written English
* Willingness to share their Fitbit data with the study team
Exclusion Criteria:
* Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
* Currently pregnan…
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
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors