Psychological Services Integration in Gynecological Oncology Clinics

Completed · Phase 1

Conditions studied: Gynecologic Oncology Patient

In brief

The purpose of this study is to understand the feasibility and impact of integrated psychological care in outpatient gynecologic oncology clinics with the goal of creating a new standard of care. The investigators propose an intervention study comparing patient-centered outcomes (assessed by surveys) between women who receive usual care versus integrated psychological care. The investigators' objectives are to learn about the process of integration of psychological care directly into outpatient gynecologic oncology clinics and the impact of such integration on patients' well-being, presentation of symptoms, psychological functioning, coping mechanisms, awareness of support services offered, and perception of quality of care. As this is a feasibility study, aims are focused on assessing patient willingness for psychological intervention in the medical office, provider willingness to have psychologist present in clinic, and impact of psychological intervention. With such data to warrant further integration and time of psychologists in medical clinics, next steps for immediate and long-term projects may include focus on high risk populations, specific disease sites, additional provider clinics, more psychologist time spent in gynecological oncology clinics, and effectiveness of interventions with higher power. The investigators hope the results will serve as preliminary data for an integrated psychosocial care model that can be implemented in other oncology clinics.

Key facts

Study ID

NCT03481127

Run by

Washington University School of Medicine

People needed

101

Starts

2018-05-08

Expected to finish

2019-03-26

Last updated by the study team

2019-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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