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A Telehealth Psychosocial Intervention (REVITALIZE) to Reduce Fatigue Interference among Patients with Advanced Ovarian Cancer on PARP Inhibitors
Trial Status: active
This clinical trial tests how well a telehealth delivered psychosocial intervention called REVITALIZE works to reduce fatigue interference in patients with ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) receiving poly (ADP-ribose) polymerase (PARP) inhibitors. Fatigue is one of the most common side effects experienced by patients with advanced cancer and is a pressing problem in the era of precision oncology. Cancer-related fatigue causes distressing physical, emotional, and cognitive exhaustion that interferes with daily functioning. REVITALIZE is a remotely-delivered telehealth intervention that helps patients identify and reduce contributors to fatigue within their control, clarify their values, align behavior with these values, and use acceptance and commitment therapy strategies to reduce the negative impacts of fatigue. REVITALIZE may help reduce the impact of fatigue on daily life and activities, and improve symptoms and quality of life in patients with advanced ovarian cancer.
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
Anticipated continued treatment with a PARP inhibitor for 8 months
English-speaking
Mean fatigue severity level >= 4 on the first three items of the Fatigue Symptom Inventory
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Willingness to use a wireless electronic pillbox 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 or the site principal investigator (PI)
Patients with severe psychiatric conditions (e.g. untreated trauma unrelated to cancer, high or imminent suicidality) as evaluated by their treating oncologist or site PI, which require more intensive psychiatric treatment than the study can provide
Patients with cognitive conditions (e.g. dementia), determined by their treating oncologist or site PI, such that they could not provide informed consent or complete the study procedures
Inability to complete the baseline measures within one week of consenting.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06710548.
I. To evaluate the effect of REVITALIZE versus (vs.) enhanced usual care (EUC) on patient-reported outcomes of fatigue interference (primary outcome) and fatigue severity, fatigue self-efficacy, fatigue catastrophizing, quality of life, and emotional distress (secondary outcomes), and cognitive function and sleep disturbance (exploratory outcomes).
SECONDARY OBJECTIVES:
I. To assess the effect of REVITALIZE vs. EUC on PARP inhibitor adherence outcomes of monthly adherence, dose interruptions and reductions, and persistence using Wisepill monitors and chart review.
II. Assess REVITALIZE theory-driven mechanisms of action – e.g. active acceptance and alignment of behavior with values – by examining mediators of REVITALIZE's effects on fatigue outcomes compared with EUC.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive EUC consisting of printed educational materials developed by the National Cancer Institute (NCI) about cancer survivorship and receive access to supportive care resources (e.g., social work, psychology, chaplains) available to patients at treating clinics on study. Patients utilize Wisepill electronic pill box on study.
ARM II: Patients participate in the REVITALIZE program consisting of telehealth sessions over 45-60 minutes once weekly (QW) for 8 weeks followed by 2 telehealth booster sessions over 15-20 minutes at 1 and 2 months after the last weekly session. Patients also receive printed educational materials developed by the NCI about cancer survivorship and utilize Wisepill electronic pill box on study.
After completion of study intervention, patients are followed up at 20 and 28 weeks.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
