Active living program for people with metastatic breast cancer
Testing the Feasibility and Acceptability of a Remotely Delivered Program to Promote Active Living Among People With Metastatic Breast Cancer
This pilot will test a mindfulness- and acceptance-based exercise program delivered with smartphone apps and telehealth to help people with metastatic breast cancer be more active and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT07238023 on ClinicalTrials.gov |
What this trial studies
This single-group, pretest-posttest pilot will enroll about 38 adults with metastatic breast cancer to pilot an acceptance- and mindfulness-based physical activity promotion program delivered via smartphone apps, Fitbit, and telehealth. Participants will receive guidance for aerobic and muscle-strengthening activities alongside mindfulness and acceptance strategies, with baseline and post-intervention measures of acceptability, feasibility, activity, symptoms, and quality of life. Eligibility requires medical clearance, ECOG performance status 0–1, estimated life expectancy ≥6 months, and ability to use a smartphone and web interface. Findings will be used to inform scalable strategies to promote active living in people with advanced cancer.
Who should consider this trial
Good fit: Ideal candidates are adults with metastatic breast cancer who have medical clearance for exercise, ECOG performance status of 0–1, an expected life expectancy of at least six months, and the ability to use a smartphone and web apps.
Not a fit: Patients with medical contraindications to exercise (for example uncontrolled cardiac disease or hypertension), ECOG ≥2, very limited life expectancy, or who cannot use the required smartphone/web tools are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could offer a scalable telehealth approach to increase physical activity and reduce fatigue and psychological distress in people living with metastatic breast cancer.
How similar studies have performed: While general physical activity interventions have shown benefit and safety in people with metastatic cancer, mindfulness- and acceptance-based activity programs tailored to this population are relatively novel and have had limited prior testing.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * having been diagnosed with metastatic breast cancer * medical clearance from healthcare provider to participate in this study * life expectancy of at least 6 months as per the participant's healthcare provider * Eastern Cooperative Oncology Group performance status of or 0 or 1 * being willing and able to use a smartphone and web interface with or without assistance; if assistance is needed, it must be readily available * adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report * adequate motor capacity to use a smartphone and web interface as indicated by self-report * willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes as needed * completed baseline survey Exclusion Criteria: * contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease noted by the patient's treating healthcare provider) * presence of bone metastases deemed unstable by the treating healthcare provider. * untreated brain metastases * history of dementia or other major neurocognitive disorder * received a diagnosed of Major Depressive Disorder within the previous 6 months * received a diagnosis of a major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study * currently hospitalized * enrolled in hospice * inability to speak, read, and write in English at the 7th grade level
Where this trial is running
Oklahoma City, Oklahoma
- TSET Health Promotion Research Center — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Michael C Robertson, MPH, PhD — University of Oklahoma
- Study coordinator: Michael C Robertson, PhD, MPH
- Email: Michael-Robertson@ou.edu
- Phone: 14052718001
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.