REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors

Not Applicable

Recruiting

• Conditions: Ovarian Cancer; Advanced Ovarian Carcinoma; Fallopian Tube Carcinoma; Primary Peritoneal Cancer; PARP Inhibitor; Fatigue Related to Cancer Treatment; Fatigue in Cancer Survivors

• Registration Number: NCT06710548
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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

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 Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Study Start: 2025-03-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2028-10-31
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fatigue Interference Score from Baseline to 20 weeks (Arms 1 and 2)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Fatigue Interference Score from Baseline to 28 weeks (Arms 1 and 2)	28 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 (28 weeks) will be computed using a two-sample t-test with a 0.95 confidence interval.
Change in Fatigue from Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
Change in Fatigue from Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
Change in Fatigue Self-Efficacy Score from Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
Change in Fatigue Self-Efficacy Score from Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
Change in Fatigue Catastrophizing Score from Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
Change in Fatigue Catastrophizing Score from Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
Change in Participant Sleep Disturbance from Baseline to 8 weeks (Arms 1 and 2)	8 weeks	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.
Change in Participant Sleep Disturbance from Baseline to 13 weeks (Arms 1 and 2)	13 weeks	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.
Change in Participant Sleep Disturbance from Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
Change in Quality of Life Score from Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
Change in Quality of Life Score from Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
Emotional Distress: Anxiety Symptoms from Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
Emotional Distress: Anxiety Symptoms from Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
Emotional Distress: Depressive Symptoms from Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
Emotional Distress: Depressive Symptoms from Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
Poly-ADP Ribose Polymerase (PARP) Inhibitor Adherence Rate From Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
PARP Inhibitor Adherence Rate From Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
PARP Inhibitor Non-Persistence From baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
PARP Inhibitor Non-Persistence From baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 20 weeks (Arms 1 and 2)	20 weeks	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.
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 28 weeks (Arms 1 and 2)	28 weeks	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.
Change in Value-Aligned Behavior Score From Baseline to 8 weeks (Arms 1 and 2)	8 weeks	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.
Change in Value-Aligned Behavior Score From Baseline to 13 weeks (Arms 1 and 2)	13 weeks	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.
Change in Acceptance and Cognitive Defusion from Baseline to 8 weeks (Arms 1 and 2)	8 weeks	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.
Change in Acceptance and Cognitive Defusion from Baseline to 13 weeks (Arms 1 and 2)	13 weeks	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.
Acceptability of Intervention (Arms 1 and 2)	20 weeks	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

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States