Improving physical activity and mindfulness in breast cancer survivors
Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
This study is testing a 24-week program to see if adding social support and mindfulness training can help breast cancer survivors be more active and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05931874 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance physical activity levels and mindfulness among breast cancer survivors through a 24-week intervention that incorporates various mHealth components. Researchers will identify which social support and mindfulness training elements are most effective in promoting moderate to vigorous physical activity (MVPA) and will assess the impact of these changes on symptom burden, activity levels, and sleep quality. Participants will be breast cancer survivors who have completed their primary treatment and will be supported by a 'buddy' throughout the intervention. The study will also explore mediators and moderators that may influence the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are female breast cancer survivors aged 18 and older who are within 5 years post-diagnosis and currently engage in less than 60 minutes of moderate to vigorous physical activity per week.
Not a fit: Patients who are not breast cancer survivors or those who are currently undergoing primary treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the physical and mental well-being of breast cancer survivors.
How similar studies have performed: Previous studies have shown promising results in using mindfulness and physical activity interventions for cancer survivors, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 pregnant or plans to become pregnant * Plans to move out of the United States in next 18 months * Current enrollment in another dietary or physical activity trial * Inability to provide informed consent * Prisoners or other detained individuals
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Siobhan M Phillips, PhD, MPH — Northwestern University
- Study coordinator: Siobhan M Phillips, PhD, MPH
- Email: smphillips@northwestern.edu
- Phone: 312-503-4235
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.