Revitalize Program for Ovarian Cancer

Recruiting at 8 trial locations

Overseen By Hannah Park, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Must be taking: PARP inhibitors

Disqualifiers: Severe psychiatric, Untreated clinical, Cognitive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 28 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program called REVITALIZE can reduce fatigue in individuals with ovarian cancer who are taking PARP inhibitors, a type of medication. Participants will either receive the REVITALIZE intervention, which includes coaching sessions, or educational materials about managing fatigue. The study seeks individuals with ovarian cancer who are currently taking a PARP inhibitor and experiencing moderate to severe fatigue. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance fatigue management for many.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be on a PARP inhibitor for at least 2 months and plan to continue it for at least 7 months.

What prior data suggests that the Revitalize Intervention is safe for participants with ovarian cancer?

Research has shown that the Revitalize program is safe for people with ovarian cancer. Studies have found it effective and well-received by patients using PARP inhibitors. These studies have reported no major safety problems. Participants found it helpful in reducing tiredness and improving overall quality of life. This indicates the program is generally well-tolerated and could be a safe choice for those interested in joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Revitalize Intervention for ovarian cancer because it combines medication adherence tools with personalized coaching, offering a comprehensive support system for patients. Unlike standard treatments that often focus solely on medication, this approach includes eight weekly one-on-one sessions via Zoom, plus booster sessions to reinforce the benefits. This tailored support is designed to improve medication adherence and address cancer survivorship challenges, potentially enhancing overall patient outcomes.

What evidence suggests that the Revitalize Intervention is effective for reducing fatigue in ovarian cancer patients?

Research has shown that the REVITALIZE program, available to participants in this trial, can help reduce tiredness in ovarian cancer patients taking PARP inhibitors. A previous study found that this telehealth program, which includes one-on-one sessions with a coach, led to less tiredness among participants. This is important because tiredness can greatly affect daily life and activities. The program teaches skills to better manage tiredness. This supportive approach has shown promising results for those dealing with cancer-related tiredness. ^{1 3 5 6 7}

Who Is on the Research Team?

Alexi A Wright, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Joanna J Arch, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

This trial is for adults with ovarian cancer who are currently taking PARP inhibitors and experiencing fatigue. Participants should be willing to undergo a psychosocial intervention aimed at reducing fatigue.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My fatigue level is high, scoring 4 or more.

I am an adult who has finished initial treatment for ovarian, fallopian tube, or peritoneal cancer.

Exclusion Criteria

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

I have a health condition, not related to PARP inhibitors, that could cause fatigue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the REVITALIZE telehealth intervention or educational materials, including the use of a wireless pill bottle and completion of questionnaires.

28 weeks

8 weekly sessions, 2 booster sessions via Zoom

Follow-up

Participants are monitored for changes in fatigue interference, fatigue severity, and other health outcomes.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Revitalize Intervention

Trial Overview The study is testing the effectiveness of the REVITALIZE intervention against Enhanced Usual Care (EUC) in reducing fatigue for ovarian cancer patients on PARP inhibitors.

How Is the Trial Designed?

Group I: ARM 1: REVITALIZE Intervention Experimental Treatment 1 Intervention

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.

Group II: ARM 2: Educational Materials Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The REVITALIZE telehealth intervention was found to be feasible and acceptable for patients with advanced ovarian cancer on PARP inhibitors, with a high completion rate of 86.3% for the 12-week follow-up assessment.

Participants in the REVITALIZE group experienced significant reductions in fatigue interference and severity, as well as improved overall fatigue levels, compared to those receiving enhanced usual care, suggesting that this intervention could help manage treatment-related fatigue effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue. Wright, AA., Poort, H., Tavormina, A., et al.[2023]

Ovarian cancer survivors face significant psychosocial challenges, including high levels of distress, depression, and anxiety, particularly among younger survivors under 45, who report lower quality of life compared to older survivors.

Access to social support and relational support is crucial for these survivors, as feelings of isolation are common, and addressing their psychosocial needs can lead to improvements in quality of life and personal relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A literature review of the social and psychological needs of ovarian cancer survivors. Roland, KB., Rodriguez, JL., Patterson, JR., et al.[2022]

The LIVES NRG 0225 study is a large randomized controlled trial involving women with stage II-IV ovarian cancer, aiming to determine if a 24-month lifestyle intervention focused on a high vegetable and fiber, low-fat diet and increased physical activity can improve progression-free survival (PFS) after treatment.

This study will also assess quality of life (QoL) and gastrointestinal health, using a comprehensive approach that includes dietary adherence monitoring and mechanistic biomarker analysis, making it the largest behavior-based lifestyle intervention trial for ovarian cancer survivors to date.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of diet and physical activity in women treated for stage II-IV ovarian cancer: Rationale and design of the Lifestyle Intervention for Ovarian Cancer Enhanced Survival (LIVES): An NRG Oncology/Gynecologic Oncology Group (GOG-225) Study. Thomson, CA., Crane, TE., Miller, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04525183

REVITALIZE: A Telehealth Intervention for Women With ... This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825823014622

Pilot randomized trial of an acceptance-based telehealth ... REVITALIZE, an ACT-based intervention, reduced fatigue in ovarian cancer patients with PARP-inhibitor associated fatigue. •. REVITALIZE–a brief, acceptance ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/560450

REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian ... 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 ...

4. dana-farber.org dana-farber.org/clinical-trials/24-105

Randomized trial of REVITALIZE: A telehealth intervention ... The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities.

5. withpower.com withpower.com/trial/phase-ovarian-neoplasms-2025-061b2

Revitalize Program for Ovarian Cancer Trial Overview The study is testing the effectiveness of the REVITALIZE intervention against Enhanced Usual Care (EUC) in reducing fatigue for ovarian cancer ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37708581/

Pilot randomized trial of an acceptance-based telehealth ... REVITALIZE also showed promise for improved fatigue self-efficacy, fatigue catastrophizing, anxiety, depression, and quality of life (ds = 0.60-0.86, p ≥ .05).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06710548

REVITALIZE: RCT to Reduce Fatigue in Adults With ... The purpose of this study is to see whether a supportive intervention (REVITALIZE) reduces fatigue and its impact on daily life and activities for ...