- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481127
Psychological Services Integration in Gynecological Oncology Clinics
Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 years or older
- Scheduled for an appointment in a gynecologic oncology clinic at the Siteman Cancer Center at the Center for Advanced Medicine or the Women's Tumor Clinic at the Center for Outpatient Health at Barnes-Jewish Hospital
- Patients may or may not have a cancer diagnosis.
- All gynecologic cancer types, histologic grades, primary or recurrent disease.
- Patients actively undergoing treatment or close observation
- Pregnant or lactating patients
- Able to speak and read English
- Able to consent
Inclusion criteria (correlative studies only) -Patients who are undergoing pre-operative work-up for evaluation of an adnexal mass by a Washington University gynecologic oncologist.
Exclusion Criteria:
-Impaired by a psychiatric or cognitive disorder that limits their ability to give consent or communicate with their medical providers about symptoms (as determined by the patient's medical team)
Exclusion criteria (correlative studies only)
- Neoadjuvant chemotherapy
- Treatment within the past month with antidepressant medications that affect serotonin physiology
- Specific histology: low malignant potential tumors, non-epithelial cancer histology.
- Previous cancer diagnosis within the past five years or recurrent cancer
- Regular steroid use in the last month
- Presence of comorbidities with known effects on the immune system (e.g., systemic lupus erythematosus, multiple sclerosis, and rheumatoid arthritis), congestive heart failure, pregnancy, or stroke within the past six months
- Major surgery in the past month.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 1: Usual Care
-No psychosocial care in clinic
|
|
Experimental: Arm 2: Integrated Care
-Those who receive integrated care will receive a one-page care plan completed by Dr. Vanderlan including their scores from screening questionnaires , recommendations for coping strategies and available supportive resources.
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Additional possible strategies used may include supportive or validating interventions, increasing/introducing/reinforcing coping strategies, psychoeducation; distress tolerance skills; brief cognitive behavioral therapy; cognitive restructuring; activity scheduling; acceptance; and relaxation/mindfulness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
Time Frame: Completion of patient enrollment (approximately 12 months)
|
-Willingness to participate with integrated care as quantified by proportion of enrolled patients from the number of approached eligible patients
|
Completion of patient enrollment (approximately 12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider willingness to have a psychologist present
Time Frame: 6 months after start of study enrollment
|
-5 item survey about willingness to have psychologist present in clinic
|
6 months after start of study enrollment
|
Differences in clinic visit duration with and without a psychologist present
Time Frame: Day 1
|
-Clinic visit duration is defined as the time from check-in to patient discharge
|
Day 1
|
Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care
Time Frame: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Difference in psychological correlates of daily functioning as measured by patient depression between women who receive usual care versus integrated psychological care
Time Frame: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Difference in psychological correlates of daily functioning as measured by patient anxiety between women who receive usual care versus integrated psychological care
Time Frame: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Difference in psychological correlates of daily functioning as measured by patient quality of life between women who receive usual care versus integrated psychological care
Time Frame: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Difference in psychological correlates of daily functioning as measured by patient coping mechanisms between women who receive usual care versus integrated psychological care
Time Frame: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Difference in psychological correlates of perception of psychological care as measured by patient perception of Siteman Cancer Center being highly focused on their wellbeing between women who receive usual care versus integrated psychological care
Time Frame: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Difference in psychological correlates of awareness of psychological care as measured by awareness of support services offered between women who receive usual care versus integrated psychological care
Time Frame: Enrollment, 3 months after enrollment, and 6 months after enrollment
|
|
Enrollment, 3 months after enrollment, and 6 months after enrollment
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jessica Vanderlan, Ph.D., Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 201711117
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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