Clinical trial · Interventional
REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
NCT04525183CI-TRIAL-00082603completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 life and activities.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Coping Behavior | — | UNRESOLVED | — |
| Coping Skills | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Usual Care (EOC) | Behavioral | — | UNRESOLVED |
| REVITALIZE ACT Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Run In
- description
- Recruit up to 5 patients who meet eligibility criteria to participate in the run-in period of the study * Participants will receive a 6-week Acceptance and Commitment Therapy (ACT) intervention (REVITALIZE).
- interventionNames
- Behavioral: REVITALIZE ACT Intervention
- type
- EXPERIMENTAL
- label
- Enhanced Usual Care (EUC)
- description
- Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
- interventionNames
- Behavioral: Enhanced Usual Care (EOC)
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- RESULTWright AA, Poort H, Tavormina A, Schmiege SJ, Matulonis UA, Campos SM, Liu JF, Slivjak ET, Gilmour AL, Salinger JM, Haggerty AF, Arch JJ. Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue. Gynecol Oncol. 2023 Oct;177:165-172. doi: 10.1016/j.ygyno.2023.08.020. Epub 2023 Sep 13. PMID 37708581