Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians

NCT07282158 | Recruiting

• 3 other identifiers: RG1125922NCI-2025-07869FHIRB0021069
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial tests an adapted version of the Helping Ovarian Cancer Patients Cope (HOPE) intervention to address burnout among gynecologic oncology clinicians. Stress and burnout among gynecologic oncology clinicians can have far-reaching impacts not only on physicians at the individual level (e.g., distress, mental illness) but also at the professional (e.g., worse patient outcomes, increased errors) and societal levels (fewer physicians in this specialty, more system strain). The original Helping Ovarian Cancer Patients Cope (HOPE) is a workshop to promote hope among patients with ovarian cancer through creating positive narratives using the hope theory and social-cognitive theory. The adapted intervention for clinicals (HOPE-C) will use the same concepts but tailored to clinician experiences by fostering peer support and retelling their challenging stories and may address burnout for gynecologic oncology clinicians.

Conditions

Ovarian Carcinoma; Psychiatric Disorder

Outcome Measures

Primary Outcomes (8)

• Objective 1: Clinician feedback for Helping Ovarian Cancer Patients Cope-Clinician Burnout (HOPE-C)

  Will assess clinician's feedback around the content, delivery structure, and materials for the adapted HOPE-C intervention. Qualitative Description will be used to analyze the data.

  Day 1

• Objective 2: Feasibility (Accrual rate)

  Feasibility cutoff includes ≥ 50% of eligible clinicians enrolling in the study.

  At time of enrollment

• Objective 2: Feasibility (Rate of intervention completion)

  Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all sessions.

  At 4 weeks

• Objective 2: Feasibility (Rate of survey completion)

  Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all surveys.

  At baseline and 2-week post-intervention

• Objective 2: Acceptability of HOPE-C

  Assessed by the Theoretical Framework of Acceptability (TFA) questionnaire, which is an 8-item questionnaire assessing acceptability of healthcare interventions across seven constructions: Affective Attitude, Burden, Ethicality, Intervention Coherence, Opportunity Costs, Perceived Effectiveness and Self-efficacy. Items are rated on a 5-point Likert scale (e.g., 1 = strongly dislike, 5 = strongly like) and a mean is computed across all seven constructs (n=7 items) and a single outcome is examined for the general item. Total mean score ranges from 1 to 5, with higher scores indicating greater acceptability of the intervention.

  At 2-week post-intervention

• Objective 2: Satisfaction of HOPE-C

  Will be assessed by using three items assessing overall satisfaction. A cutoff score of ≥ 7 (out of 10) will be used for each satisfaction item.

  At 2-week post-intervention

• Objective 3: Optimization of the intervention

  Feedback will be gathered from clinicians who participated in the intervention to assess their feedback on how to optimize the intervention in clinical settings.

  At 2-week post-intervention

• Objective 3: Delivery of the intervention

  Feedback will be gathered from clinicians who participated in the intervention to assess their feedback on the delivery of the intervention in clinical settings.

  At 2-week post-intervention

Study Arms (1)

HOPE-C intervention

EXPERIMENTAL

OBJECTIVE 1 DEVELOPMENT OF INTERVENTION: Clinicians review HOPE-C intervention materials and complete an interview and questionnaire on study. Feedback from Objective 1 will be incorporated into the HOPE-C intervention delivered in Objective 2. OBJECTIVE 2 PILOT TRIAL: Clinicians attend HOPE-C sessions (changing their narrative, managing life's uncertainty and finding meaning) once weekly for 4 weeks, with each session lasting approximately 30-45 minutes. Clinicians complete a questionnaire before and after completing all HOPE-C sessions. OBJECTIVE 3: Clinicians may undergo an interview after completing HOPE-C sessions.

Behavioral: Behavioral Intervention; Other: Interview; Other: Survey Administration

Interventions

Behavioral Intervention BEHAVIORAL

Complete HOPE-C sessions

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments, Behavioural

HOPE-C intervention

Interview OTHER

Complete interview

HOPE-C intervention

Survey Administration OTHER

Ancillary studies

HOPE-C intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years of age or older
• English speaking
• Able to provide informed consent
• Working with patients with ovarian cancer (gynecologic oncologists, medical oncologists, nurses, social workers, and advance practice providers \[APPs\])

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Andy Hill CARE Fund: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Mental Disorders

Interventions

Behavior Therapy; Memory and Learning Tests; Interviews as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Neuropsychological Tests; Psychological Tests; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Megan J. Shen, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan J. Shen, PhD

CONTACT

206-667-4172; mshen2@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 15, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)