REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors

Launched by DANA-FARBER CANCER INSTITUTE · Nov 26, 2024

Keywords

ClinConnect Summary

The REVITALIZE clinical trial is studying a program designed to help reduce fatigue and improve daily life for women with ovarian cancer who are receiving a specific type of treatment called PARP inhibitors. Fatigue can be a significant issue for cancer patients, and this study aims to see if the REVITALIZE program can make a difference for those feeling tired due to their treatment. Participants will be divided into two groups: one group will receive the REVITALIZE intervention, while the other will get educational materials to help them understand their condition and treatment better.

To be eligible for this trial, participants need to be adults aged 18 or older who have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer and have completed initial treatment like surgery and chemotherapy. They should have been on PARP inhibitors for at least two months and plan to continue for at least seven more months. Additionally, they should be English-speaking and experiencing a certain level of fatigue. Participants will use a special wireless pill bottle for their medication and will complete questionnaires to help assess their fatigue levels. This study is currently recruiting participants and aims to provide valuable insights into managing fatigue for women undergoing cancer treatment.

Gender

FEMALE

Eligibility 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.