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

Summary

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

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.

Conditions8

Locations6 sites

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