Clinical trial NCT04525183: REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Official title: REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Fatigue
Coping Behavior
Coping Skills
Keywords: Ovarian Cancer
Fatigue
Coping Behavior
Coping Skills
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: National Comprehensive Cancer Network
First posted: 2020-08-25
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 0-2.
* 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

Primary outcomes:
measure: Fatigue Interference
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Fatigue Severity
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Current Fatigue
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
Secondary outcomes:
measure: Emotional Distress: Anxiety Symptoms
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Fear of Cancer Recurrence
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Participant Quality of Life
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Emotional Distress: Depressive Symptoms
timeFrame: Change from baseline to 4-weeks, 8-weeks, and 12-weeks
Other outcomes:
measure: Adherence
timeFrame: Change from baseline to 12-weeks
measure: Catastrophizing
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Fatigue Self-Efficacy
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Psychological Flexibility
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Experiential Avoidance
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Value: Progress
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
measure: Valuing: Obstruction
timeFrame: Change from baseline to 4-, 8-, and 12-weeks
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Alexi A Wright, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: Joanna J Arch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Hanneke MD Poort, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.