REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Fatigue Interference
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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 reduces 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. The ACT intervention will be delivered by masters' level psychologists at The University of Colorado Boulder. 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.
Investigators
Alexi A. Wright, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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-
- •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
Outcomes
Primary Outcomes
Fatigue Interference
Time Frame: Change from baseline to 4-, 8-, and 12-weeks
Changes in fatigue interference were measured using the validated 7-item interference scale of the Fatigue Symptom Inventory scale. Interference items assessed the degree to which fatigue interfered with general levels of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. Fatigue interference was scored on an 11-point scale, ranging from 0 (no interference) to 10 (extreme interference). Interference items were summed to obtain a total perceived interference score, with higher scores indicating greater fatigue interference.
Fatigue Severity
Time Frame: Change from baseline to 4-, 8-, and 12-weeks
The Fatigue Symptom Inventory (FSI), is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life. Severity is measured on separate 11-point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured as the number of days in the past week (0-7) that respondents felt fatigued as well as the extent of each day on average they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on separate 11-point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue in the past week was judged to interfere with general level of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. Higher FSI scores are associated with worse outcomes.
Current Fatigue
Time Frame: Change from baseline to 4-, 8-, and 12-weeks
The Fatigue Symptom Inventory (FSI), is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life. Severity is measured on separate 11-point scales (0=not at all fatigued; 10=as fatigued as I could be) that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured as the number of days in the past week (0-7) that respondents felt fatigued as well as the extent of each day on average they felt fatigued (0=none of the day; 10=the entire day). Perceived interference is measured on separate 11-point scales (0=no interference; 10=extreme interference) that assess the degree to which fatigue in the past week was judged to interfere with general level of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations with others, enjoyment of life, and mood. Higher FSI scores are associated with worse outcomes.
Secondary Outcomes
- Emotional Distress: Anxiety Symptoms(Change from baseline to 4-, 8-, and 12-weeks)
- Fear of Cancer Recurrence(Change from baseline to 4-, 8-, and 12-weeks)
- Participant Quality of Life(Change from baseline to 4-, 8-, and 12-weeks)
- Emotional Distress: Depressive Symptoms(Change from baseline to 4-weeks, 8-weeks, and 12-weeks)