Reducing fatigue in adults with ovarian cancer on PARP inhibitors
Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
This study is testing a tele-health program called REVITALIZE to see if it can help reduce fatigue and improve daily life for adults with ovarian cancer who are taking PARP inhibitors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Aurora, Colorado and 5 other locations) |
| Trial ID | NCT06710548 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a tele-health intervention called REVITALIZE in reducing fatigue and its impact on daily life for adults with ovarian cancer who are receiving PARP inhibitors. Participants will be randomly assigned to either the REVITALIZE intervention or to receive educational materials. The study will involve screening for eligibility, using a wireless pill bottle for medication adherence, and completing questionnaires over a period of approximately 7 months. The trial aims to enroll around 240 participants and is supported by the National Cancer Institute.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with ovarian, fallopian tube, or primary peritoneal cancers who have been on PARP inhibitors for at least 2 months.
Not a fit: Patients with untreated comorbid conditions that could explain their fatigue or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for patients suffering from fatigue due to ovarian cancer treatments.
How similar studies have performed: Other studies have shown promising results with similar supportive interventions for cancer-related fatigue, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age ≥ 18 years) with ovarian, fallopian tube, or primary peritoneal cancers (hereafter ovarian cancer) who have completed primary therapy (surgery and chemotherapy). * Treated with a PARP inhibitor as maintenance therapy for ≥2 months and plan to continue for at least 7 months. * English-speaking. * Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory. * ECOG performance status of 0-2. * Willing to use a wireless pill bottle for PARP inhibitor medication. Exclusion Criteria: * Untreated clinical condition or comorbid condition that pre-dates PARP inhibitor use and could explain fatigue, as evaluated by their treating oncologist. * Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist, which require more intensive psychiatric treatment than the study can provide. * Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist, such that they could not provide informed consent or complete the study procedures. * Inability to complete the first questionnaire within one week of consent.
Where this trial is running
Aurora, Colorado and 5 other locations
- University of Colorado Cancer Center-Anschutz — Aurora, Colorado, United States (Recruiting)
- University of Colorado Boulder — Boulder, Colorado, United States (Recruiting)
- Massachusetts General Hospital-Cancer Center — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Duke Cancer Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Alexi A Wright, MD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Hannah Park, BS
- Email: revitalize@dfci.harvard.edu
- Phone: 857.215.4936
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.