Program to help breast cancer survivors manage fatigue
Feasibility and Early Efficacy of the Maximizing Energy Intervention for Decreasing Fatigue Impact in Breast Cancer Survivors
This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their fatigue better than a general health education program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06879522 on ClinicalTrials.gov |
What this trial studies
This study is testing a program called Maximizing Energy aimed at helping women who have completed treatment for breast cancer manage their fatigue. The research has two main goals: to evaluate the feasibility of delivering the program and to compare its effectiveness against a general health education program in reducing cancer-related fatigue. Participants will be randomly assigned to either the Maximizing Energy intervention or the health education program, with assessments conducted before, after, and one month post-intervention to measure changes in fatigue levels.
Who should consider this trial
Good fit: Ideal candidates are adult women who have completed treatment for Stages I-IIIa breast cancer and experience moderate to severe fatigue.
Not a fit: Patients with major depressive disorder, psychosis, or other disabilities unrelated to breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life for breast cancer survivors by reducing fatigue.
How similar studies have performed: Other studies have shown promise in using self-management and educational interventions to address cancer-related fatigue, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult (18 years and older) pre and post-menopausal female at birth diagnosed with Stages I-IIIa breast cancer, * completed primary treatment for breast cancer (surgery, chemotherapy, radiation) at least 6 months prior to ensure that fatigue is stable and chronic, - moderate to severe fatigue based on score ≥ 4 on the 7-point Fatigue Severity Scale, * able to speak and understand English * has a mobile device that runs on the Apple or Android platform Exclusion Criteria: * major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months and * disability due to diagnoses other than breast cancer.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Ketki Raina, PhD, OTR/L, FAOTA — University of Pittsburgh
- Study coordinator: Tracey Y Murray
- Email: tym2@pitt.edu
- Phone: 412-624-3961
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.