Ovarian CancerNCT06710548
REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
A study testing REVITALIZE Intervention and Educational Materials in people with Ovarian Cancer and Advanced Ovarian Carcinoma, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Advanced Ovarian Carcinoma, Fallopian Tube Carcinoma
- What is being tested?
- REVITALIZE Intervention and Educational Materials
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Mar 2025to 31 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
University of Colorado Cancer Center-Anschutz
Aurora, Colorado, 80045
Evamaria Bravo, MS, 303-724-0131, evamaria.kentbravo@cuanschutz.edu
Carolyn Lefkowits, MD, MPH, MS
- Recruiting
Massachusetts General Hospital-Cancer Center
Boston, Massachusetts, 02114
Richard Penson, MBBS, 617-724-4800, rpenson@mgb.org
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Page Widick, MD, 617-667-2100, pwidick@bidmc.harvard.edu
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Alexi Wright, MD, MPH, 617-632-2334, Alexi_Wright@dfci.harvard.edu
Alexi Wright, MD, MPH
- Recruiting
University of Colorado Boulder
Boulder, Colorado, 80309
Madeline Nealis, MPH, 720-515-9461, revitalize@colorado.edu
Sarah Genung, BA MSc, 720-515-9461, revitalize@colorado.edu
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Amelia Scott, 919-613-4584, amelia.lorenzo@duke.edu
Laura Havrilesky, MD, MHSc
About this study
Official title: 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:
- REVITALIZE
- Educational Materials
Read the 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.
- Conditions
- Ovarian Cancer, Advanced Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Cancer, PARP Inhibitor, Fatigue Related to Cancer Treatment
- Being tested
- REVITALIZE Intervention, Educational Materials
- 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
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVITALIZE InterventionBehavioural
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.
Educational MaterialsBehavioural
The educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: REVITALIZE Intervention | Experimental | 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. Receives: Behavioral: REVITALIZE Intervention |
| ARM 2: Educational Materials | Active comparator | 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. Receives: Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 weeks
Secondary outcomes (28)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start17 Mar 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alexi A. Wright, MD, Dana-Farber Cancer Institute
- Investigators
- Alexi A Wright, MD, MPH, Principal investigator, Dana-Farber Cancer InstituteJoanna J Arch, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710548
- Sponsor's protocol ID
- 24-105
- Other IDs
- R01CA289547
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Arch JJ, Uno H, Poort H, Slivjak E, Nealis MS, Park H, Wang I, Genung SR, Cronin A, Andorsky DJ, Havrilesky LJ, Penson RT, Mazina V, Widick P, Lefkowits C, Wright AA. Randomized clinical trial of an Acceptance and Commitment Therapy telehealth intervention ('REVITALIZE') to reduce fatigue interference in women with advanced ovarian cancer on PARP inhibitors: study protocol. BMC Cancer. 2026 Apr 2;26(1):613. doi: 10.1186/s12885-026-15936-0.
PubMed 41928160
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of REVITALIZE: A Telehealth Intervention to Reduce Fatigue Interference Among Adults With Advanced Ovarian Cancer on PARP Inhibitors
- ClinicalTrials.gov ID
- NCT06710548
- Acronym / sponsor ID
- 24-105
- Conditions
- Ovarian Cancer, Advanced Ovarian Carcinoma, Fallopian Tube Carcinoma, Primary Peritoneal Cancer, PARP Inhibitor, Fatigue Related to Cancer Treatment
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- REVITALIZE
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1: REVITALIZE Intervention | Experimental | Behavioral: REVITALIZE Intervention120 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. |
| ARM 2: Educational Materials | Active comparator | Behavioral: Educational Materials120 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REVITALIZE InterventionA 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. | Behavioural | ARM 1: REVITALIZE Intervention |
| Educational MaterialsThe educational materials arm will receive specialized cancer survivorship educational materials created by the National Cancer Institute | Behavioural | ARM 2: Educational Materials |
Primary outcome
Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
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.
28 secondary outcomes
Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Change in Fatigue Catastrophizing Score from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
Change in Fatigue Catastrophizing Score from Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Change in Participant Sleep Disturbance from Baseline to 8 weeks (Arms 1 and 2)
Time frame: 8 weeks
Change in Participant Sleep Disturbance from Baseline to 13 weeks (Arms 1 and 2)
Time frame: 13 weeks
Change in Participant Sleep Disturbance from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
Change in Quality of Life Score from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
Change in Quality of Life Score from Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Emotional Distress: Anxiety Symptoms from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
Emotional Distress: Anxiety Symptoms from Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Emotional Distress: Depressive Symptoms from Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
Emotional Distress: Depressive Symptoms from Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Poly-ADP Ribose Polymerase (PARP) Inhibitor Adherence Rate From Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
PARP Inhibitor Adherence Rate From Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
PARP Inhibitor Non-Persistence From baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
PARP Inhibitor Non-Persistence From baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 20 weeks (Arms 1 and 2)
Time frame: 20 weeks
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 28 weeks (Arms 1 and 2)
Time frame: 28 weeks
Change in Value-Aligned Behavior Score From Baseline to 8 weeks (Arms 1 and 2)
Time frame: 8 weeks
Change in Value-Aligned Behavior Score From Baseline to 13 weeks (Arms 1 and 2)
Time frame: 13 weeks
Change in Acceptance and Cognitive Defusion from Baseline to 8 weeks (Arms 1 and 2)
Time frame: 8 weeks
Change in Acceptance and Cognitive Defusion from Baseline to 13 weeks (Arms 1 and 2)
Time frame: 13 weeks
Acceptability of Intervention (Arms 1 and 2)
Time frame: 13 weeks
Acceptability of Intervention (Arms 1 and 2)
Time frame: 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 41928160Arch JJ, Uno H, Poort H, Slivjak E, Nealis MS, Park H, Wang I, Genung SR, Cronin A, Andorsky DJ, Havrilesky LJ, Penson RT, Mazina V, Widick P, Lefkowits C, Wright AA. Randomized clinical trial of an Acceptance and Commitment Therapy telehealth intervention ('REVITALIZE') to reduce fatigue interference in women with advanced ovarian cancer on PARP inhibitors: study protocol. BMC Cancer. 2026 Apr 2;26(1):613. doi: 10.1186/s12885-026-15936-0.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexi A Wright, MD, MPH principal investigator
Dana-Farber Cancer Institute
Joanna J Arch, PhD principal investigator
University of Colorado, Boulder
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REVITALIZE Intervention and Educational Materials in people with Ovarian Cancer and Advanced Ovarian Carcinoma, run by Dana-Farber Cancer Institute at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Park, BS (857.215.4936, revitalize@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06710548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.