NCT03481127

Psychological Services Integration in Gynecological Oncology Clinics

Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gynecologic Oncology Patient

Interventions

Type	Name	Description
BEHAVIORAL	Integrated psychological care	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.
OTHER	Surveys	* NCCN Distress Thermometer * PROMIS Depression \& Anxiety * Quality of Life (SF-12) * Brief COPE * Patient awareness and satisfaction survey
PROCEDURE	Blood draw	* For patients with ovarian, fallopian tube, or primary peritoneal cysts * Optional * Enrollment, 3 months after enrollment, and 6 months after enrollment
PROCEDURE	Fresh tissue from ovary	* For patients with ovarian, fallopian tube, or primary peritoneal cysts * Optional * At time of standard of care surgery

Timeline

• Start date: 2018-05-08
• Primary completion: 2018-08-29
• Completion: 2019-03-26
• First posted: 2018-03-29
• Last updated: 2019-06-03

Locations

1 site across 1 country: United States