Status:
COMPLETED
REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
AstraZeneca
National Comprehensive Cancer Network
Conditions:
Ovarian Cancer
Fatigue
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily lif...
Detailed Description
This is a two-arm, multicenter pilot randomized controlled trial to compare the feasibility, acceptability, and preliminary efficacy of REVITALIZE, a 6-week Acceptance and Commitment Therapy (ACT) tel...
Eligibility Criteria
Inclusion
- Women ≥18 years of age who have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Receiving PARPI inhibitors for ≥ 2 months.
- Able to read/speak English.
- Have an Eastern Oncology Group (ECOG) performance of 0-2.
- Report moderate-severe fatigue in the past week (average score ≥4 on a Fatigue Symptom Inventory scale of 0-10)
Exclusion
- Patients with an untreated clinical condition or comorbid illness (e.g. anemia, hypothyroidism) that could explain their fatigue.
- Patients with chronic severe fatigue that pre-dates their use of PARPi.
- The following special populations will be excluded from this research:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04525183
Start Date
December 2 2020
End Date
August 9 2022
Last Update
November 15 2024
Active Locations (2)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104