Revitalize Program for Ovarian Cancer

Recruiting at 3 trial locations

Overseen By Irene Wang, MPH

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

Trial Summary

What is the purpose of this trial?

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

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 safety data exists for the Revitalize Program for Ovarian Cancer?

The Revitalize Program, evaluated as an acceptance-based telehealth intervention for women with ovarian cancer experiencing fatigue from PARP inhibitors, was found to be feasible and acceptable in a pilot trial, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is the Revitalize Intervention treatment for ovarian cancer different from other treatments?

The Revitalize Intervention for ovarian cancer may focus on addressing the psychosocial needs of patients, which is a unique aspect compared to traditional treatments that primarily target the physical aspects of the disease. This approach could include support groups, counseling, and other resources to improve the overall well-being and quality of life for patients. ^{6 7 8 9 10}

Research Team

Alexi A Wright, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Measuring Quality of Life in Ovarian Cancer Clinical Trials-Can We Improve Objectivity and Cross Trial Comparisons? [2020]

3. England pubmed.ncbi.nlm.nih.gov

Assessment of risk factors for 30-day hospital readmission after surgical cytoreduction in epithelial ovarian carcinoma. [2019]

4. United States 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. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Patient and family member perspectives on searching for cancer clinical trials: A qualitative interview study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A pilot study: evaluation of a psychosocial program for women with gynecological cancers. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Secondary cytoreduction--thoughts on the "pro" side. [2005]

8. China pubmed.ncbi.nlm.nih.gov

[Multidisciplinary treatment of recurrent epithelial ovarian carcinoma and prognostic analysis]. [2015]

9. England pubmed.ncbi.nlm.nih.gov

A literature review of the social and psychological needs of ovarian cancer survivors. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Enhanced Recovery After Surgery for Advanced Ovarian Cancer: A Systematic Review of Interventions Trialed. [2018]