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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDana-Farber Cancer Institute

About this trial

The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for participants with ovarian cancer taking PARP inhibitors.

The name of the study groups in this research study are:

1. REVITALIZE 2. Educational Materials

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • REVITALIZE Intervention
  • Educational Materials

Treatment groups

240 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dana-Farber Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator