Clinical trial NCT06710548: REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
Official title: Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Advanced Ovarian Carcinoma
Fallopian Tube Carcinoma
Primary Peritoneal Cancer
PARP Inhibitor
Fatigue Related to Cancer Treatment
Fatigue in Cancer Survivors
Keywords: Ovarian Cancer
Advanced Ovarian Carcinoma
Advanced Ovarian Cancer
Primary Peritoneal Cancer
Fallopian Tube Cancer
Fatigue related to cancer treatment
Fatigue in Cancer Survivors
PARP inhibitor
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-29
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: This Phase 3 randomized controlled trial will evaluate the effect of a brief, acceptance-based tele-health intervention (REVITALIZE) vs. educational materials in participants with ovarian cancer who are taking poly-ADP ribose polymerase (PARP) inhibitors.

Participants will be randomized into one of two study groups: 1) REVITALIZE or 2) Educational Materials. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, using a wireless pill bottle, and completing questionnaires.

Participation in this research study is expected to last about 7 months.

It is expected about 240 people will take part in this research study.

The National Cancer Institute is supporting this research by providing funding.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
Secondary outcomes:
measure: Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Change in Fatigue Catastrophizing Score from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: Change in Fatigue Catastrophizing Score from Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Change in Participant Sleep Disturbance from Baseline to 8 weeks (Arms 1 and 2)
timeFrame: 8 weeks
measure: Change in Participant Sleep Disturbance from Baseline to 13 weeks (Arms 1 and 2)
timeFrame: 13 weeks
measure: Change in Participant Sleep Disturbance from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: Change in Quality of Life Score from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: Change in Quality of Life Score from Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Emotional Distress: Anxiety Symptoms from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: Emotional Distress: Anxiety Symptoms from Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Emotional Distress: Depressive Symptoms from Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: Emotional Distress: Depressive Symptoms from Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Poly-ADP Ribose Polymerase (PARP) Inhibitor Adherence Rate From Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: PARP Inhibitor Adherence Rate From Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: PARP Inhibitor Non-Persistence From baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: PARP Inhibitor Non-Persistence From baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 20 weeks (Arms 1 and 2)
timeFrame: 20 weeks
measure: PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 28 weeks (Arms 1 and 2)
timeFrame: 28 weeks
measure: Change in Value-Aligned Behavior Score From Baseline to 8 weeks (Arms 1 and 2)
timeFrame: 8 weeks
measure: Change in Value-Aligned Behavior Score From Baseline to 13 weeks (Arms 1 and 2)
timeFrame: 13 weeks
measure: Change in Acceptance and Cognitive Defusion from Baseline to 8 weeks (Arms 1 and 2)
timeFrame: 8 weeks
measure: Change in Acceptance and Cognitive Defusion from Baseline to 13 weeks (Arms 1 and 2)
timeFrame: 13 weeks
measure: Acceptability of Intervention (Arms 1 and 2)
timeFrame: 13 weeks
measure: Acceptability of Intervention (Arms 1 and 2)
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alexi A Wright, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: