Psychological Services Integration in Gynecological Oncology Clinics

NCT03481127 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2019-06-03

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Barnes-Jewish Hospital

    collaborator OTHER
  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Jessica Vanderlan, Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2018-08-29
Completion
2019-03-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481127 on ClinicalTrials.gov