Trial NCT06710548
REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
- Phase
- Not given
- Sponsor
- Dana-Farber Cancer Institute
- Conditions
- Ovarian Cancer; Advanced Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Cancer; PARP Inhibitor; Fatigue Related to Cancer Treatment; Fatigue in Cancer Survivors
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Language
* Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.
* ECOG performance status of 0-2.Performance status
* 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.
Restrictions found (2)
- LanguageOutrightinclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-2
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital-Cancer Center · Boston, Suffolk County
- Beth Israel Deaconess Medical Center · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County