Ovarian CarcinomaNCT07282158
Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians
A study testing Behavioral Intervention, Interview and Survey Administration in people with Ovarian Carcinoma and Psychiatric Disorder, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ovarian Carcinoma, Psychiatric Disorder
- What is being tested?
- Behavioral Intervention, Interview and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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])
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Megan J. Shen, PhD, 206-667-4172, mshen2@fredhutch.org
Megan J. Shen, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Carcinoma, Psychiatric Disorder
- Being tested
- Behavioral Intervention, Interview, Survey Administration
- Medical subject headings
- Ovarian Neoplasms, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Complete HOPE-C sessions
InterviewOther
Complete interview
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Intervention; Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Objective 2: Feasibility (Accrual rate)
Feasibility cutoff includes ≥ 50% of eligible clinicians enrolling in the study.
Measured: At time of enrollment
Objective 2: Feasibility (Rate of intervention completion)
Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all sessions.
Measured: At 4 weeks
Objective 2: Feasibility (Rate of survey completion)
Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all surveys.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 2-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start24 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Andy Hill CARE Fund
- Responsible party
- Sponsor
- Investigators
- Megan J. Shen, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282158
- Sponsor's protocol ID
- RG1125922
- Other IDs
- NCI-2025-07869, FHIRB0021069
- Status last verified
- Jun 2026
- First submitted
- 1 Dec 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Helping Ovarian Cancer Patients Cope (HOPE) for Clinician Burnout (HOPE-C)
- ClinicalTrials.gov ID
- NCT07282158
- Acronym / sponsor ID
- RG1125922
- Conditions
- Ovarian Carcinoma, Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Andy Hill CARE Fund
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HOPE-C intervention | Experimental | Behavioral: Behavioral Intervention, Other: Interview, Other: Survey AdministrationOBJECTIVE 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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])
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyComplete HOPE-C sessions | Behavioural | HOPE-C intervention |
| InterviewComplete interview | Other | HOPE-C intervention |
| Survey AdministrationAncillary studies | Other | HOPE-C intervention |
Primary outcome
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.
Objective 2: Feasibility (Accrual rate)
Time frame: At time of enrollment
Feasibility cutoff includes ≥ 50% of eligible clinicians enrolling in the study.
Objective 2: Feasibility (Rate of intervention completion)
Time frame: At 4 weeks
Feasibility cutoff includes ≥ 50% of enrolled clinicians completing all sessions.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan J. Shen, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention, Interview and Survey Administration in people with Ovarian Carcinoma and Psychiatric Disorder, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan J. Shen, PhD (206-667-4172, mshen2@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective 1: Clinician feedback for Helping Ovarian Cancer Patients Cope-Clinician Burnout (HOPE-C) (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.