REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
- Conditions
- Registration Number
- NCT06710548
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief Summary
The purpose of this study is to see whether a psychosocial 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
* Enhanced Usual Care (EUC)
- Detailed Description
This Phase 3, non-therapeutic, randomized controlled trial will evaluate the effect of a brief, acceptance-based telehealth intervention (REVITALIZE) vs. enhanced usual care control (EUC) in participants with advanced ovarian cancer who are receiving poly-ADP ribose polymerase (PARP) inhibitors.
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Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 240
- 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.
- English-speaking.
- Mean fatigue severity level ≥4 on the first three items of the Fatigue Symptom Inventory.
- ECOG performance status of 0-2.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Fatigue Interference Score from Baseline to 4 Months (ARM 1) 4 months 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 (4 m...
Change in Fatigue Interference Score from Baseline to 4 Months (ARM 2) 4 months 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 (4 mo...
- Secondary Outcome Measures
Name Time Method Change in Fatigue Interference Score from Baseline to 6 Months (ARM 1) 6 months 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 (6 m...
Change in Fatigue Interference Score from Baseline to 6 Months (ARM 2) 6 months 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 (6 m...
Change in Fatigue Severity Score from Baseline to 4-Months (ARM 1) 4 months 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 (4 months) will be computed...
Change in Fatigue Severity Score from Baseline to 4-Months (ARM 2) 4 months 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 (4 months) will be computed...
Change in Fatigue Severity Score from Baseline to 6-Months (ARM 1) 6 months 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 (6 months) will be computed ...
Change in Fatigue Severity Score from Baseline to 6-Months (ARM 2) 6 months 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 (6 months) will be computed ...
Change in Fatigue Self-Efficacy Score from Baseline to 4-months (ARM 1) 4 months 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 poin...
Change in Fatigue Self-Efficacy Score from Baseline to 4-months (ARM 2) 4 months 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...
Change in Fatigue Self-Efficacy Score from Baseline to 6-months (ARM 1) 6 months 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 ...
Change in Fatigue Self-Efficacy Score from Baseline to 6-months (ARM 2) 6 months 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...
Change in Fatigue Catastrophizing Score from Baseline to 4-months (ARM 1) 4 months 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 (4 months) will be co...
Change in Fatigue Catastrophizing Score from Baseline to 4-months (ARM 2) 4 months 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 (4 months) will be co...
Change in Fatigue Catastrophizing Score from Baseline to 6-months (ARM 1) 6 months 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 (6 months) will be co...
Change in Fatigue Catastrophizing Score from Baseline to 6-months (ARM 2) 6 months 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 (6 months) will be com...
Change in Quality of Life Score from Baseline to 4-months (ARM 1) 4 months Assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), a 18-item measure with answers rated on a 5-point scale (0 "Not at all" to 4 "Very much" with a total scores range of 0 to 108, and a higher score representing greater deficits in participant well-being. The mean change from baseline to the follow up time point (4 months) will be compu...
Change in Quality of Life Score from Baseline to 4-months (ARM 2) 4 months Assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), a 18-item measure with answers rated on a 5-point scale (0 "Not at all" to 4 "Very much" with a total scores range of 0 to 108, and a higher score representing greater deficits in participant well-being. The mean change from baseline to the follow up time point (4 months) will be compu...
Change in Quality of Life Score from Baseline to 6-months (ARM 1) 6 months Assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), a 18-item measure with answers rated on a 5-point scale (0 "Not at all" to 4 "Very much" with a total scores range of 0 to 108, and a higher score representing greater deficits in participant well-being The mean change from baseline to the follow up time point (6 months) will be comput...
Change in Quality of Life Score from Baseline to 6-months (ARM 2) 6 months Assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), a 18-item measure with answers rated on a 5-point scale (0 "Not at all" to 4 "Very much" with a total scores range of 0 to 108, and a higher score representing greater deficits in participant well-being The mean change from baseline to the follow up time point (6 months) will be comput...
Poly-ADP Ribose Polymerase (PARP) Inhibitor Adherence Rate From Baseline to 4-months (ARM 1) 4 months 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 (4 months) will be computed using a two-sample t-test with a 0.95 confidence interval...
PARP Inhibitor Adherence Rate From Baseline to 4-months (ARM 2) 4 months 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 (4 months) will be computed using a two-sample t-test with a 0.95 confidence interval.
PARP Inhibitor Adherence Rate From Baseline to 6-months (ARM 1) 6 months 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 (6 months) will be computed using a two-sample t-test with a 0.95 confidence interval.
PARP Inhibitor Adherence Rate From Baseline to 6-months (ARM 2) 6 months 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 (6 months) will be computed using a two-sample t-test with a 0.95 confidence interval.
PARP Inhibitor Non-Persistence From baseline to 4-Months (ARM 1) 4 months Defined as Wisepill pillbox monitoring detecting that a participant stops taking medication entirely from Baseline through 4 month follow up. 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 4 month follow up. T...
PARP Inhibitor Non-Persistence From baseline to 4-Months (ARM 2) 4 months Defined as Wisepill pillbox monitoring detecting that a participant stops taking medication entirely from Baseline through 4 month follow up. 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 4 month follow up. T...
PARP Inhibitor Non-Persistence From baseline to 6-Months (ARM 1) 6 months Defined as Wisepill pillbox monitoring detecting that a participant stops taking medication entirely from Baseline through 4 month follow up. The measure will be quantified as yes/no binary outcomes with yes = any dose delay \[or interruption\] from baseline to 6 month follow up and no = no dose delay \[or interruption\] from baseline to 4 month follow up. T...
PARP Inhibitor Non-Persistence From baseline to 6-Months (ARM 2) 6 months Defined as Wisepill pillbox monitoring detecting that a participant stops taking medication entirely from Baseline through 4 month follow up. The measure will be quantified as yes/no binary outcomes with yes = any dose delay \[or interruption\] from baseline to 6 month follow up and no = no dose delay \[or interruption\] from baseline to 4 month follow up. T...
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 4 Months (ARM 1) 4 months 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 4 month follow up. The proportion and a corresponding 0.95 asymptotic confidence interval...
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 4 Months (ARM 2) 4 months 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 4 month follow up. The proportion and a corresponding 0.95 asymptotic confidence interval...
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 6 Months (ARM 1) 6 months 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 6 month follow up and no = no dose delay \[or interruption\] from baseline to 6 month follow up. The proportion and a corresponding 0.95 asymptotic confidence interval...
PARP Inhibitor Regimen by Medical Chart Abstraction From Baseline to 6 Months (ARM 2) 6 months 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 6 month follow up and no = no dose delay \[or interruption\] from baseline to 6 month follow up. The proportion and a corresponding 0.95 asymptotic confidence interval...
Change in Value-Aligned Behavior Score From Baseline to 2 Months (Arm 1) 2 months 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 base...
Change in Value-Aligned Behavior Score From Baseline to 2 Months (Arm 2) 2 months 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 ba...
Change in Value-Aligned Behavior Score From Baseline to 4 Months (Arm 1) 4 months 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 base...
Change in Value-Aligned Behavior Score From Baseline to 4 Months (Arm 2) 4 months 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 base...
Change in Value-Aligned Behavior Score From Baseline to 6 Months (Arm 1) 6 months 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 base...
Change in Value-Aligned Behavior Score From Baseline to 6 Months (Arm 2) 6 months 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 base...
Change in Decentering Scale Score From Baseline to 2 Months (ARM 1) 2 months Assessed by the Experiences Questionnaire-Decentering scale, a 13-item survey rated on a 5 point scale with answers ranging from 1 "Never" to 5 "All the time" with a total scores range of 13 to 65 and with a higher score representing a participant's ability to observe thoughts, feelings, and bodily sensations as transient mental events rather than truths or ...
Change in Decentering Scale Score From Baseline to 2 Months (ARM 2) 2 months Assessed by the Experiences Questionnaire-Decentering scale, a 13-item survey rated on a 5 point scale with answers ranging from 1 "Never" to 5 "All the time" with a total scores range of 13 to 65 and with a higher score representing a participant's ability to observe thoughts, feelings, and bodily sensations as transient mental events rather than truths or ...
Change in Decentering Scale Score From Baseline to 4 Months (ARM 1) 4 months Assessed by the Experiences Questionnaire-Decentering scale, a 13-item survey rated on a 5 point scale with answers ranging from 1 "Never" to 5 "All the time" with a total scores range of 13 to 65 and with a higher score representing a participant's ability to observe thoughts, feelings, and bodily sensations as transient mental events rather than truths or ...
Change in Decentering Scale Score From Baseline to 4 Months (ARM 2) 4 months Assessed by the Experiences Questionnaire-Decentering scale, a 13-item survey rated on a 5 point scale with answers ranging from 1 "Never" to 5 "All the time" with a total scores range of 13 to 65 and with a higher score representing a participant's ability to observe thoughts, feelings, and bodily sensations as transient mental events rather than truths or ...
Change in Decentering Scale Score From Baseline to 6 Months (ARM 1) 6 months Assessed by the Experiences Questionnaire-Decentering scale, a 13-item survey rated on a 5 point scale with answers ranging from 1 "Never" to 5 "All the time" with a total scores range of 13 to 65 and with a higher score representing a participant's ability to observe thoughts, feelings, and bodily sensations as transient mental events rather than truths or ...
Change in Decentering Scale Score From Baseline to 6 Months (ARM 2) 6 months Assessed by the Experiences Questionnaire-Decentering scale, a 13-item survey rated on a 5 point scale with answers ranging from 1 "Never" to 5 "All the time" with a total scores range of 13 to 65 and with a higher score representing a participant's ability to observe thoughts, feelings, and bodily sensations as transient mental events rather than truths or ...
Change in Participant Satisfaction Score from Baseline to 4-Months (ARM 1) 4 months Assessed by the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item survey rated on a 4 point scale with answers ranging from Poor/ No, definitely not/ None of my needs have been met/ Quite dissatisfied/ No, they really didn't help to Excellent/ Yes, definitely/ Almost all of my needs have been met/ Very satisfied/ Yes, they helped a great deal. Total sco...
Change in Participant Satisfaction Score from Baseline to 4-Months (ARM 2) 4 months Assessed by the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item survey rated on a 4 point scale with answers ranging from Poor/ No, definitely not/ None of my needs have been met/ Quite dissatisfied/ No, they really didn't help to Excellent/ Yes, definitely/ Almost all of my needs have been met/ Very satisfied/ Yes, they helped a great deal. Total sco...
Change in Participant Satisfaction Score from Baseline to 6-Months (ARM 1) 6 months Assessed by the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item survey rated on a 4 point scale with answers ranging from Poor/ No, definitely not/ None of my needs have been met/ Quite dissatisfied/ No, they really didn't help to Excellent/ Yes, definitely/ Almost all of my needs have been met/ Very satisfied/ Yes, they helped a great deal. Total sco...
Change in Participant Satisfaction Score from Baseline to 6-Months (ARM 2) 6 months Assessed by the Client Satisfaction Questionnaire-8 (CSQ-8), an 8-item survey rated on a 4 point scale with answers ranging from Poor/ No, definitely not/ None of my needs have been met/ Quite dissatisfied/ No, they really didn't help to Excellent/ Yes, definitely/ Almost all of my needs have been met/ Very satisfied/ Yes, they helped a great deal. Total sco...
Trial Locations
- Locations (1)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States