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Behavioral Intervention

Telehealth Intervention for Ovarian Cancer-Related Fatigue

N/A
Waitlist Available
Led By Alexi A Wright, MD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women ≥18 years of age who have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
Receiving PARPI inhibitors for ≥ 2 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8- and 12-weeks
Awards & highlights

Study Summary

This trialis exploring if a 6-week online program can help ovarian cancer patients with fatigue caused by their meds to reduce fatigue's impact on daily life.

Who is the study for?
This trial is for English-speaking women over 18 with ovarian, fallopian tube, or primary peritoneal carcinoma who have been on PARP inhibitors for at least 2 months and are experiencing moderate to severe fatigue. They should be able to perform daily activities (ECOG performance 0-2). Pregnant women, prisoners, those unable to consent, or patients with other medical conditions causing fatigue cannot participate.Check my eligibility
What is being tested?
The study is examining a telehealth program called REVITALIZE ACT Intervention over six weeks against Enhanced Usual Care (EOC) in helping reduce the impact of PARP inhibitor-related fatigue on daily life and activities among women with advanced ovarian cancer.See study design
What are the potential side effects?
Since this trial focuses on a skills-based intervention rather than medication, side effects may not be as common as drug trials. However, participants might experience emotional distress or discomfort when discussing their experiences with fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women who are at least 18 years old and have been diagnosed with certain types of cancer in the abdomen.
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You have been taking PARP inhibitors for at least 2 months.
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You are able to perform daily activities with little to no difficulty.
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You have experienced significant tiredness in the past week, with an average score of 4 or higher on a scale of 0 to 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8- and 12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8- and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrollment Rate
Fatigue Change
Retention Rate
Secondary outcome measures
Emotional Distress
Emotional well-being
Fear of Cancer Recurrence (FCRI)
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Run InExperimental Treatment1 Intervention
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).
Group II: REVITALIZE ACT InterventionExperimental Treatment1 Intervention
Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted.
Group III: Enhanced Usual Care (EUC)Experimental Treatment1 Intervention
Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,357 Total Patients Enrolled
38 Trials studying Ovarian Cancer
4,463 Patients Enrolled for Ovarian Cancer
AstraZenecaIndustry Sponsor
4,238 Previous Clinical Trials
288,471,372 Total Patients Enrolled
47 Trials studying Ovarian Cancer
23,801 Patients Enrolled for Ovarian Cancer
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,586 Total Patients Enrolled
4 Trials studying Ovarian Cancer
92 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for participants to join this clinical experiment?

"The clinicaltrials.gov portal does not have evidence of any open recruitment for this trial; it was initially posted on December 2, 2020 and last updated October 13th 2022. Nevertheless, there are currently 917 other medical studies enrolling patients at the present time."

Answered by AI

What is the ultimate goal of this clinical research endeavor?

"The primary outcome being monitored by AstraZeneca, the study sponsor, is Fatigue Change over a period of 12 weeks. Secondary outcomes are Physical well-being (measured on FACT-O's 5 point Likert Scale with scores ranging 0 to 28), Emotional Well-being (also measured on FACT-O's 5 point Likert Scale with score range from 0 to 28) and Functional Well-Being (again evaluated by FACT - O's five point scale that ranges between 0 and 28)."

Answered by AI
~12 spots leftby Mar 2025