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

Dana-Farber Cancer Institute

Status: Active, not recruiting

Conditions: Coping Skills; Coping Behavior; Fatigue; Ovarian Cancer

Treatments: Behavioral: REVITALIZE ACT Intervention; Behavioral: Enhanced Usual Care (EOC)

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT04525183

20-285

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

Run In

Experimental group

Description:

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).

Treatment:

Behavioral: REVITALIZE ACT Intervention

Enhanced Usual Care (EUC)

Experimental group

Description:

Participants randomized to EUC will receive educational materials developed by the National Comprehensive Cancer Network (NCCN) about fatigue and exercise during cancer treatment.

Treatment:

Behavioral: Enhanced Usual Care (EOC)

REVITALIZE ACT Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: REVITALIZE ACT Intervention