- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07282158
Adapted Helping Ovarian Cancer Patients Cope Intervention to Address Burnout for Gynecologic Oncology Clinicians
Adaptation of Helping Ovarian Cancer Patients Cope (HOPE) for Clinician Burnout (HOPE-C)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Megan J. Shen, PhD
- Phone Number: 206-667-4172
- Email: mshen2@fredhutch.org
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutch/University of Washington Cancer Consortium
-
Contact:
- Megan J. Shen, PhD
- Phone Number: 206-667-4172
- Email: mshen2@fredhutch.org
-
Principal Investigator:
- Megan J. Shen, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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. |
Ancillary studies
Complete interview
Complete HOPE-C sessions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Megan J. Shen, PhD, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
- Mental Disorders
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Psychotherapy
- Behavioral Disciplines and Activities
- Psychological Tests
- Neuropsychological Tests
- Interviews as Topic
- Behavior Therapy
- Memory and Learning Tests
Other Study ID 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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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