Randomized trial of REVITALIZE: A telehealth intervention to reduce fatigue interference among adults with advanced ovarian cancer on PARP inhibitors

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

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.