REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
1 other identifier
interventional
49
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable ovarian-cancer
Started Dec 2020
Shorter than P25 for not_applicable ovarian-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 25, 2020
CompletedStudy Start
First participant enrolled
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2022
CompletedResults Posted
Study results publicly available
November 15, 2024
CompletedNovember 15, 2024
September 1, 2024
1.7 years
August 10, 2020
October 12, 2023
September 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Fatigue Interference
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.
Change from baseline to 4-, 8-, and 12-weeks
Fatigue Severity
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.
Change from baseline to 4-, 8-, and 12-weeks
Current Fatigue
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.
Change from baseline to 4-, 8-, and 12-weeks
Secondary Outcomes (4)
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
Other Outcomes (7)
Adherence
Change from baseline to 12-weeks
Catastrophizing
Change from baseline to 4-, 8-, and 12-weeks
Fatigue Self-Efficacy
Change from baseline to 4-, 8-, and 12-weeks
- +4 more other outcomes
Study Arms (3)
Run In
EXPERIMENTALRecruit 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).
Enhanced Usual Care (EUC)
EXPERIMENTALParticipants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.
REVITALIZE ACT Intervention
EXPERIMENTALParticipants 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.
Interventions
Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- AstraZenecacollaborator
- National Comprehensive Cancer Networkcollaborator
Study Sites (2)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
Wright AA, Poort H, Tavormina A, Schmiege SJ, Matulonis UA, Campos SM, Liu JF, Slivjak ET, Gilmour AL, Salinger JM, Haggerty AF, Arch JJ. Pilot randomized trial of an acceptance-based telehealth intervention for women with ovarian cancer and PARP inhibitor-related fatigue. Gynecol Oncol. 2023 Oct;177:165-172. doi: 10.1016/j.ygyno.2023.08.020. Epub 2023 Sep 13.
PMID: 37708581RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Alexi Wright
- Organization
- Dana-Farber Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Alexi A Wright, MD, MPH
Dana-Farber Cancer Institute
- PRINCIPAL INVESTIGATOR
Joanna J Arch, PhD
University of Colorado, Boulder
- PRINCIPAL INVESTIGATOR
Hanneke MD Poort, PhD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 25, 2020
Study Start
December 2, 2020
Primary Completion
August 9, 2022
Study Completion
August 9, 2022
Last Updated
November 15, 2024
Results First Posted
November 15, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research