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

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

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cancer; Fallopian Tube Carcinoma; Primary Peritoneal Cancer; PARP Inhibitor; Advanced Ovarian Carcinoma; Fatigue Related to Cancer Treatment; Fatigue in Cancer Survivors
• Intervention / Treatment: Behavioral: REVITALIZE Intervention; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene Wang, MPH; Phone Number: 617.582.7238; Email: revitalize@dfci.harvard.edu
• Study Contact Backup: Name: Hannah Park, BS; Phone Number: 857.215.4936; Email: revitalize@dfci.harvard.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Cancer Center-Anschutz
      • Principal Investigator: Carolyn Lefkowits, MD, MPH, MS
      • Contact: Evamaria Bravo, MS; Phone Number: 303-724-0131; Email: evamaria.kentbravo@cuanschutz.edu
    • Boulder, Colorado, United States, 80309
      • Recruiting
      • University of Colorado Boulder
      • Contact: Madeline Nealis, MPH; Phone Number: 720-515-9461; Email: revitalize@colorado.edu
      • Contact: Sarah Genung, BA MSc; Phone Number: 720-515-9461; Email: revitalize@colorado.edu
      • Principal Investigator: Joanna J Arch, PhD
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Alexi Wright, MD, MPH; Phone Number: 617-632-2334; Email: Alexi_Wright@dfci.harvard.edu
      • Principal Investigator: Alexi Wright, MD, MPH
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Page Widick, MD; Phone Number: 617-667-2100; Email: pwidick@bidmc.harvard.edu
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital-Cancer Center
      • Contact: Richard Penson, MBBS; Phone Number: 617-724-4800; Email: rpenson@mgb.org
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Cancer Center
      • Contact: Amelia Scott; Phone Number: 919-613-4584; Email: amelia.lorenzo@duke.edu
      • Principal Investigator: Laura Havrilesky, MD, MHSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM 1: REVITALIZE Intervention; 120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following: Questionnaire upon enrollment.; Use of a wireless pill bottle for PARP inhibitor medication.; Eight weekly one-on-one intervention sessions with a coach via Zoom.; Two booster sessions to reinforce intervention with a coach via Zoom.; Questionnaires at 8, 13, 20, and 28 weeks.	Behavioral: REVITALIZE Intervention; A remotely delivered tele-health intervention to address cancer fatigue that is based on an acceptance-based approach. The intervention includes 8 one-on-one weekly sessions and 2 booster sessions with trained psychology doctoral students based at University of Colorado. Sessions will focus on fatigue education, Acceptance and Commitment Therapy (ACT) skills, and behavior changes. Wi-Fi enabled tablets and keyboards will be provided to participants if needed. All sessions will be conducted via the Zoom platform and will either be videotaped or audiotaped.
Active Comparator: ARM 2: Educational Materials; 120 participants will be randomized in a 1:1 fashion stratified by PARP inhibitor type and study site and will complete the following: Questionnaire upon enrollment.; Use of wireless pill bottle for PARP inhibitor medication.; Educational information on cancer survivorship, including management of fatigue.; Questionnaires at 8, 13, 20, and 28 weeks.	Behavioral: Educational Materials; The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)	Assessed by the 7-item Fatigue Interference subscale of the Fatigue Symptom Inventory (FSI). Items are rated on an 11-point scale (0 = no interference; 10 = extreme interference), with a total scores range of 0 to 70 with the higher score representing greater fatigue interference with daily life. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2)	Assessed by the 7-item Fatigue Interference subscale of the Fatigue Symptom Inventory (FSI). Items are rated on an 11-point scale (0 = no interference; 10 = extreme interference), with a total scores range of 0 to 70 with the higher score representing greater fatigue interference with daily life. The mean change from baseline to the follow up time point (28 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	28 weeks
Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2)	Assessed by the Patient-Reported Outcome Measurement Information system (PROMIS) Cancer Fatigue Short Form 7a, a 7-item measure rated on a 5-point scale (1 "never" to 5 "always") with a total scores range of 7 to 35, and a higher score representing greater fatigue severity. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	20 weeks
Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2)	Assessed by the Patient-Reported Outcome Measurement Information system (PROMIS) Cancer Fatigue Short Form 7a, a 7-item measure rated on a 5-point scale (1 "never" to 5 "always") with a total scores range of 7 to 35, and a higher score representing greater fatigue severity.The mean change from baseline to the follow up time point (28 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	28 weeks
Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2)	Assessed by the Fatigue Self-Efficacy Scale, a 7-item measure that is rated on a 4 point scale of 1 "No, I am convinced that this is not the case" to 4 "Yes, I am convinced of that." A total scores range would be 7 to 28 with a higher score representing greater belief in the ability to improve fatigue. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	20 weeks
Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2)	Assessed by the Fatigue Self-Efficacy Scale, a 7-item measure that is rated on a 4 point scale of 1 "No, I am convinced that this is not the case" to 4 "Yes, I am convinced of that." A total scores range would be 7 to 28 with a higher score representing greater belief in the ability to improve fatigueThe mean change from baseline to the follow up time point (28 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	28 weeks
Change in Fatigue Catastrophizing Score from Baseline to 20 weeks (Arms 1 and 2)	Assessed by the Fatigue Catastrophizing Scale, a 10-item survey rated on a 5 point scale with answers ranging from 1 "Never True" to 5 "All of the time true." A total scores range would be 7 to 50 with a higher score representing greater participant catastrophizing about fatigue. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	20 weeks
Change in Fatigue Catastrophizing Score from Baseline to 28 weeks (Arms 1 and 2)	Assessed by the Fatigue Catastrophizing Scale, a 10-item survey rated on a 5 point scale with answers ranging from 1 "Never True" to 5 "All of the time true." A total scores range would be 7 to 50 with a higher score representing greater participant catastrophizing about fatigue. The mean change from baseline to the follow up time point (28 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	28 weeks
Change in Participant Sleep Disturbance from Baseline to 8 weeks (Arms 1 and 2)	Assessed by the PROMIS Sleep Disturbance Short Form 8a, an 8-item survey rated on a 5 point scale with answers ranging from (1 'Very Good' to 5 'Very Poor' or 1 'Very Much' to 5 'Not At All'), where lower scores represent less disturbance.	8 weeks
Change in Participant Sleep Disturbance from Baseline to 13 weeks (Arms 1 and 2)	Assessed by the PROMIS Sleep Disturbance Short Form 8a, an 8-item survey rated on a 5 point scale with answers ranging from (1 'Very Good' to 5 'Very Poor' or 1 'Very Much' to 5 'Not At All'), where lower scores represent less disturbance.	13 weeks
Change in Participant Sleep Disturbance from Baseline to 20 weeks (Arms 1 and 2)	Assessed by the PROMIS Sleep Disturbance Short Form 8a, an 8-item survey rated on a 5 point scale with answers ranging from (1 'Very Good' to 5 'Very Poor' or 1 'Very Much' to 5 'Not At All'), where lower scores represent less disturbance.	20 weeks
Change in Quality of Life Score from Baseline to 20 weeks (Arms 1 and 2)	Assessed by the PROMIS Global Health 10, a 10-item measure of physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, and ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. Answers are rated on a 5-point scale (1 "Poor" to 5 "Excellent"; 1 "Not at all" to "Completely", where higher scores represents better participant well-being. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	20 weeks
Change in Quality of Life Score from Baseline to 28 weeks (Arms 1 and 2)	Assessed by the PROMIS Global Health 10, a 10-item measure of physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, and ability to carry out usual social activities and roles, pain, fatigue and overall quality of life. Answers are rated on a 5-point scale (1 "Poor" to 5 "Excellent"; 1 "Not at all" to "Completely", where higher scores represents better participant well-being. The mean change from baseline to the follow up time point (28 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	28 weeks
Emotional Distress: Anxiety Symptoms from Baseline to 20 weeks (Arms 1 and 2)	Assessed using the Generalized Anxiety Disorder 7-Item (GAD-7), which is a reliable and validated self-report measure to assess anxiety symptoms. For the GAD-7, respondents rated how often they have been bothered by 7 anxiety symptoms over the past 2 weeks using the following scale: 0 = Not at all; 1 = Several Days; 2 = Over half the days; and 3 = Nearly every day. Respondents also answer a question to assess the duration of their anxiety symptoms. The scale is scored 0-21, where 0-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and scores >15 is severe anxiety. Using a cut-off of 8 the GAD-7 has a sensitivity of 92% and specificity of 76% for diagnosis generalized anxiety disorder.	20 weeks
Emotional Distress: Anxiety Symptoms from Baseline to 28 weeks (Arms 1 and 2)	Assessed using the Generalized Anxiety Disorder 7-Item (GAD-7), which is a reliable and validated self-report measure to assess anxiety symptoms. For the GAD-7, respondents rated how often they have been bothered by 7 anxiety symptoms over the past 2 weeks using the following scale: 0 = Not at all; 1 = Several Days; 2 = Over half the days; and 3 = Nearly every day. Respondents also answer a question to assess the duration of their anxiety symptoms. The scale is scored 0-21, where 0-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and scores >15 is severe anxiety. Using a cut-off of 8 the GAD-7 has a sensitivity of 92% and specificity of 76% for diagnosis generalized anxiety disorder.	28 weeks
Emotional Distress: Depressive Symptoms from Baseline to 20 weeks (Arms 1 and 2)	Assessed using 8-item Patient Health Questionnaire (PHQ-8), which is a reliable and validated self-report measure to assess depressive symptoms. For the PHQ-8, respondents rated how often they have been bothered by 8 symptoms of depression over the past 2 weeks using the following scale: 0 = Not at all; 1 = Several Days; 2 = Over half the days; and 3 = Nearly every day. The scale is totaled (range 0-24) where total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.	20 weeks
Emotional Distress: Depressive Symptoms from Baseline to 28 weeks (Arms 1 and 2)	Assessed using 8-item Patient Health Questionnaire (PHQ-8), which is a reliable and validated self-report measure to assess depressive symptoms. For the PHQ-8, respondents rated how often they have been bothered by 8 symptoms of depression over the past 2 weeks using the following scale: 0 = Not at all; 1 = Several Days; 2 = Over half the days; and 3 = Nearly every day. The scale is totaled (range 0-24) where total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.	28 weeks
Poly-ADP Ribose Polymerase (PARP) Inhibitor Adherence Rate From Baseline to 20 weeks (Arms 1 and 2)	Calculated as the percentage of daily doses taken per 30-day month (% days Wisepill is opened once for each dose prescribed that day/ 30), using recommended methods for Wisepill pillbox data preparation and analysis. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	20 weeks
PARP Inhibitor Adherence Rate From Baseline to 28 weeks (Arms 1 and 2)	Calculated as the percentage of daily doses taken per 30-day month (% days Wisepill is opened once for each dose prescribed that day/ 30), using recommended methods for Wisepill data preparation and analysis. The mean change from baseline to the follow up time point (28 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	28 weeks
PARP Inhibitor Non-Persistence From baseline to 20 weeks (Arms 1 and 2)	Defined as Wisepill pillbox monitoring detecting that a participant stops taking medication entirely from Baseline through 20 weeks follow up. The measure will be quantified as yes/no binary outcomes with yes = any dose delay [or interruption] from baseline to 20 week follow up and no = no dose delay [or interruption] from baseline to 20 week follow up. The proportion and a corresponding 0.95 asymptotic confidence interval will be computed.	20 weeks
PARP Inhibitor Non-Persistence From baseline to 28 weeks (Arms 1 and 2)	Defined as Wisepill pillbox monitoring detecting that a participant stops taking medication entirely from Baseline through 28 week follow up. The measure will be quantified as yes/no binary outcomes with yes = any dose delay [or interruption] from baseline to 28 week follow up and no = no dose delay [or interruption] from baseline to 28 week follow up. The proportion and a corresponding 0.95 asymptotic confidence interval will be computed.	28 weeks
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 20 weeks (Arms 1 and 2)	PARP inhibitor treatment will be measured via medical chart abstraction. The measure will be quantified as yes/no binary outcomes with yes = any dose delay [or interruption] from baseline to 4 month follow up and no = no dose delay [or interruption] from baseline to 20 week follow up. The proportion and a corresponding 0.95 asymptotic confidence interval will be computed.	20 weeks
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 28 weeks (Arms 1 and 2)	PARP inhibitor treatment will be measured via medical chart abstraction. The measure will be quantified as yes/no binary outcomes with yes = any dose delay [or interruption] from baseline to 28 week follow up and no = no dose delay [or interruption] from baseline to 28 week follow up. The proportion and a corresponding 0.95 asymptotic confidence interval will be computed.	28 weeks
Change in Value-Aligned Behavior Score From Baseline to 8 weeks (Arms 1 and 2)	Mechanism measure assessed by the Valuing Questionnaire (VQ), a 10-item survey that measures value aligned behaviors in the past week. Responses are measured on a 6 point scale with answers ranging from 0 "not at all true" to 6 "completely true" with a total scores range of 0 to 60, and a higher score representing greater value to behavior alignment. The mean change from baseline to the follow up time point (8 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	8 weeks
Change in Value-Aligned Behavior Score From Baseline to 13 weeks (Arms 1 and 2)	Mechanism measure assessed by the Valuing Questionnaire (VQ), a 10-item survey that measures value aligned behaviors in the past week. Responses are measured on a 6 point scale with answers ranging from 0 "not at all true" to 6 "completely true" with a total scores range of 0 to 60, and a higher score representing greater value to behavior alignment. The mean change from baseline to the follow up time point (13 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.	13 weeks
Change in Acceptance and Cognitive Defusion from Baseline to 8 weeks (Arms 1 and 2)	Mechanism measure assessed by the Experiences Questionnaire Decentering Scale, a 13-item survey that measures acceptance and cognitive defusion. Responses are measured on a 5-point Likert scale from 1 'Never' to 5 'All the time,' range from 13 to 65, and a higher representing greater acceptance and defusion.	8 weeks
Change in Acceptance and Cognitive Defusion from Baseline to 13 weeks (Arms 1 and 2)	Mechanism measure assessed by the Experiences Questionnaire Decentering Scale, a 13-item survey that measures acceptance and cognitive defusion. Responses are measured on a 5-point Likert scale from 1 'Never' to 5 'All the time,' range from 13 to 65, and a higher representing greater acceptance and defusion.	13 weeks
Acceptability of Intervention (Arms 1 and 2)	Assessed by the Acceptability of Intervention Measure, a 4-item survey rated on a 5 point scale with answers ranging from 1 'Completely disagree' to 5 'Completely agree.' Total scores range from 4 to 20, with the higher number indicating greater satisfaction. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval	13 weeks
Acceptability of Intervention (Arms 1 and 2)	Assessed by the Acceptability of Intervention Measure, a 4-item survey rated on a 5 point scale with answers ranging from 1 'Completely disagree' to 5 'Completely agree.' Total scores range from 4 to 20, with the higher number indicating greater satisfaction. The mean change from baseline to the follow up time point (20 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval	20 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Joanna J Arch, PhD, University of Colorado, Boulder; Principal Investigator: Alexi A Wright, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PARP inhibitor; Ovarian Cancer; Advanced Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Fatigue in Cancer Survivors; Advanced Ovarian Carcinoma; Fatigue related to cancer treatment
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Fallopian Tube Diseases; Ovarian Neoplasms; Fallopian Tube Neoplasms
• Other Study ID Numbers: 24-105; R01CA289547 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No