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

• ClinicalTrials.gov Identifier: NCT04525183
• Recruitment Status: Active, not recruiting
• First Posted: August 25, 2020
• Last Update Posted: September 7, 2023
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: AstraZeneca; National Comprehensive Cancer Network
• Information provided by (Responsible Party): Alexi A. Wright, MD, Dana-Farber Cancer Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer; Fatigue; Coping Behavior; Coping Skills	Behavioral: Enhanced Usual Care (EOC); Behavioral: REVITALIZE ACT Intervention	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
• Actual Study Start Date: December 2, 2020
• Actual Primary Completion Date: July 28, 2022
• Estimated Study Completion Date: December 28, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Run In; 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; Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks
Experimental: Enhanced Usual Care (EUC); 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); Educational materials
Experimental: REVITALIZE ACT Intervention; 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; Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks

Outcome Measures

Primary Outcome Measures :

1. Enrollment Rate [ Time Frame: Baseline to 12-weeks ]
   Feasibility will be defined as ≥50% approach-to-enrollment rate of participants eligible participants and ≥70% completion of 3-month outcome assessments.
2. Retention Rate [ Time Frame: 12 weeks ]
   Acceptability will be defined as ≤20% of participants reporting high study burden and ≤20% withdrawing from the study.
3. Fatigue Change [ Time Frame: Change in fatigue from baseline to 8 weeks and baseline to 12 weeks ]
   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.

Secondary Outcome Measures :

1. Emotional Distress [ Time Frame: Change in emotional distress from baseline to 8 weeks and baseline to 12 weeks ]
   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.
2. Emotional Distress [ Time Frame: Change in emotional distress from baseline to 8 weeks and baseline to 12 weeks ]
   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.
3. Fear of Cancer Recurrence (FCRI), [ Time Frame: Baseline to 8- and 12-weeks ]

   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.

4. Physical well-being [ Time Frame: Baseline to 8- and 12-weeks ]
   Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale.
5. Social/family well-being [ Time Frame: Baseline to 8- and 12-weeks ]
   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).
6. Emotional well-being [ Time Frame: Baseline to 8- and 12-weeks ]
   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).
7. Functional well-being [ Time Frame: Baseline to 8- and 12-weeks ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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 0-2.
• 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

Contacts and Locations

Locations

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

Dana-Farber Cancer Institute

AstraZeneca

National Comprehensive Cancer Network

Investigators

• Principal Investigator: Alexi A Wright, MD, MPH; Dana-Farber Cancer Institute

More Information

• Responsible Party: Alexi A. Wright, MD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT04525183
• Other Study ID Numbers: 20-285
• First Posted: August 25, 2020
• Last Update Posted: September 7, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexi A. Wright, MD, Dana-Farber Cancer Institute:

Ovarian Cancer; Fatigue; Coping Behavior; Coping Skills

Additional relevant MeSH terms:

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fatigue; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type