REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue

Study Overview
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Brief Summary
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This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily life and activities.

Detailed Description
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This is a two-arm, multicenter pilot randomized controlled trial to compare the feasibility, acceptability, and preliminary efficacy of REVITALIZE, a 6-week Acceptance and Commitment Therapy (ACT) telehealth intervention vs. enhanced usual care (EUC) in fatigued patients with ovarian cancer on maintenance PARPi. The intervention is called REVITALIZE, and it is a structured, skills-based intervention for providing support, knowledge, and skills for coping with fatigue. This type of intervention has been used in other studies to treat symptoms such as pain, migraines, or worry. This research is being done to develop this program at the Dana-Farber Cancer Institute and the University of Pennsylvania's Abramson Cancer Center, and to get patient feedback on the telehealth intervention to improve it for a future study. The study is also making a preliminary determinations as to whether REVITALIZE does improve psychological flexibility and fatigue-related interference and reduce fatigue, psychological distress, and fear of cancer recurrence, while improving overall quality of life (QOL). The study will pre-pilot the REVITALIZE intervention in up to 5 patients at the Dana-Farber Cancer Institute (DFCI). This run-in phase serves to test and refine the newly developed 6-week ACT intervention in a smaller sample size prior to initiating the randomized control trial (RCT) portion of the study. After the ACT intervention has been tested and refined, the study will enroll and randomize 40 fatigued patients with advanced ovarian cancer on maintenance PARPi at Dana-Farber Cancer Institute and the Abramson Cancer Center at the University of Pennsylvania. Participants will be randomized to receive either a 6-week ACT intervention or enhanced usual care (educational materials). The study anticipates enrolling approximately 20 patients at each site, and 20 patients will be enrolled to each study arm. It is expected participants will remain in the study for the duration of the intervention and follow-up assessments, which is approximately 3 months. The Funding Organization for this study is the National Comprehensive Cancer Network (NCCN) and the Research Funding Provider is AstraZeneca.

Official Title
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REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue

Conditions
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Ovarian Cancer, Fatigue, Coping Behavior, Coping Skills

Intervention / Treatment
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* Behavioral: Enhanced Usual Care (EOC)
* Behavioral: REVITALIZE ACT Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women ≥18 years of age who have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Receiving PARPI inhibitors for ≥ 2 months. Able to read/speak English. Have an Eastern Oncology Group (ECOG) performance of 0-2. Report moderate-severe fatigue in the past week (average score ≥4 on a Fatigue Symptom Inventory scale of 0-10) Exclusion Criteria: Patients with an untreated clinical condition or comorbid illness (e.g. anemia, hypothyroidism) that could explain their fatigue. Patients with chronic severe fatigue that pre-dates their use of PARPi. The following special populations will be excluded from this research: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Run In<br>Recruit up to 5 patients who meet eligibility criteria to participate in the run-in period of the study Participants will receive a 6-week Acceptance and Commitment Therapy (ACT) intervention (REVITALIZE). | Behavioral: REVITALIZE ACT Intervention<br>* Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks<br>|
| Experimental: Enhanced Usual Care (EUC)<br>Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment. | Behavioral: Enhanced Usual Care (EOC)<br>* Educational materials<br>|
| Experimental: REVITALIZE ACT Intervention<br>Participants randomized to the REVITALIZE acceptance and commitment therapy (ACT) will receive 6 weekly sessions lasting approximately 60-75-minutes over a 6-8 week period, delivered face-to-face using iPads, computers or tablets, and a HIPAA-compliant platform (Zoom for Healthcare). If participants have difficulty connecting to the platform, telephone sessions are permitted. | Behavioral: REVITALIZE ACT Intervention<br>* Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment Rate | Feasibility will be defined as ≥50% approach-to-enrollment rate of participants eligible participants and ≥70% completion of 3-month outcome assessments. | Baseline to 12-weeks | 
| Retention Rate | Acceptability will be defined as ≤20% of participants reporting high study burden and ≤20% withdrawing from the study. | 12 weeks | 
| Fatigue Change | Changes in fatigue will be measured using the Fatigue Symptom Inventory scale, a 14-item, 11-point rating scale developed to assess subjective fatigue, in which higher scores indicate greater fatigue. | Change in fatigue from baseline to 8 weeks and baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional Distress | Measured by Generalized Anxiety Disorder 7 (GAD-7) scale, a 7-item measure assessing anxiety severity on a 4-point scale (0 = not at all, to 3 = nearly every day). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate more moderate to severe anxiety. | Change in emotional distress from baseline to 8 weeks and baseline to 12 weeks | 
| Emotional Distress | Measured by the Patient Health Questionnaire-8 (PHQ-8) scale, an 8-item measure assessing depression on a 4-point Likert scale (0 = not at all, to 3 = nearly every day). Higher scores indicate more severe depression. | Change in emotional distress from baseline to 8 weeks and baseline to 12 weeks | 
| Fear of Cancer Recurrence (FCRI), | Measured by the 42-item Fear of Cancer Recurrence Inventory (FCRI) scale, which evaluates 7 aspects associated with FCR: 1) triggers, 2) severity, 3) psychological distress), 4) functioning impairments, 5) insight, 6) reassurance, and 7) coping strategies. Each item is rated on a Likert scale ranging from 0 ('not at all' or 'never) to 4 ('a great deal' or 'all the time'). A total score can be obtained for each subscale, and for the total scale by summing item ratings. Higher scores indicate higher levels of FCR. | Baseline to 8- and 12-weeks | 
| Physical well-being | Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale. | Baseline to 8- and 12-weeks | 
| Social/family well-being | Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O, scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Social/family well-being (score range 0-28). | Baseline to 8- and 12-weeks | 
| Emotional well-being | Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Emotional well-being (score range 0-28). | Baseline to 8- and 12-weeks | 
| Functional well-being | Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Functional well-being (score range 0-28). | Baseline to 8- and 12-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, Fatigue, Coping Behavior, Coping Skills