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

June 15, 2026 updated by: Fred Hutchinson Cancer Center

Adaptation of Helping Ovarian Cancer Patients Cope (HOPE) for Clinician Burnout (HOPE-C)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

OUTLINE:

OBJECTIVE 1 DEVELOPMENT OF INTERVENTION: Clinicians review HOPE-C intervention materials and complete an interview and questionnaire on study.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch/University of Washington Cancer Consortium
        • Contact:
        • Principal Investigator:
          • Megan J. Shen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HOPE-C intervention

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.
Other: Survey Administration
Ancillary studies
Other: Interview
Complete interview
Behavioral: Behavioral Intervention
Complete HOPE-C sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
  • Behavioural

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective 1: Clinician feedback for Helping Ovarian Cancer Patients Cope-Clinician Burnout (HOPE-C)
Time Frame: Day 1
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)
Time Frame: At time of enrollment
Feasibility cutoff includes ≥ 50% of eligible clinicians enrolling in the study.
At time of enrollment
Objective 2: Feasibility (Rate of intervention completion)
Time Frame: At 4 weeks
Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all sessions.
At 4 weeks
Objective 2: Feasibility (Rate of survey completion)
Time Frame: At baseline and 2-week post-intervention
Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all surveys.
At baseline and 2-week post-intervention
Objective 2: Acceptability of HOPE-C
Time Frame: At 2-week post-intervention
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
Time Frame: At 2-week post-intervention
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
Time Frame: At 2-week post-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
Time Frame: At 2-week post-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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fred Hutchinson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Andy Hill CARE Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan J. Shen, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG1125922
  • NCI-2025-07869 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • FHIRB0021069 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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