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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 20 weeks