Clinical trial · Interventional
REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
NCT06710548CI-TRIAL-00107957recruitingN/AClinicalTrials.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)
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
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Fallopian Tube Carcinoma | Fallopian Tube Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Fatigue in Cancer Survivors | — | UNRESOLVED | — |
| Fatigue Related to Cancer Treatment | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| PARP Inhibitor | — | UNRESOLVED | — |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Educational Materials | Behavioral | — | UNRESOLVED |
| REVITALIZE Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM 1: REVITALIZE Intervention
- description
- 120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following: 1. Questionnaire upon enrollment. 2. Use of a wireless pill bottle for PARP inhibitor medication. 3. Eight weekly one-on-one intervention sessions with a coach via Zoom. 4. Two booster sessions to reinforce intervention with a coach via Zoom. 5. Questionnaires at 8, 13, 20, and 28 weeks.
- interventionNames
- Behavioral: REVITALIZE Intervention
- type
- ACTIVE_COMPARATOR
- label
- ARM 2: Educational Materials
- description
- 120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following: 1. Questionnaire upon enrollment. 2. Use of wireless pill bottle for PARP inhibitor medication. 3. Educational information on cancer survivorship, including management of fatigue. 4. Questionnaires at 8, 13, 20, and 28 weeks.
- interventionNames
- Behavioral: Educational Materials
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDArch JJ, Uno H, Poort H, Slivjak E, Nealis MS, Park H, Wang I, Genung SR, Cronin A, Andorsky DJ, Havrilesky LJ, Penson RT, Mazina V, Widick P, Lefkowits C, Wright AA. Randomized clinical trial of an Acceptance and Commitment Therapy telehealth intervention ('REVITALIZE') to reduce fatigue interference in women with advanced ovarian cancer on PARP inhibitors: study protocol. BMC Cancer. 2026 Apr 2;26(1):613. doi: 10.1186/s12885-026-15936-0. PMID 41928160