Psychological Services Integration in Gynecological Oncology Clinics

NCT ID: NCT03481127

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2019-03-26

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1: Usual Care

-No psychosocial care in clinic

Group Type: ACTIVE_COMPARATOR

Surveys

Intervention Type: OTHER

• NCCN Distress Thermometer
• PROMIS Depression & Anxiety
• Quality of Life (SF-12)
• Brief COPE
• Patient awareness and satisfaction survey

Blood draw

Intervention Type: PROCEDURE

• For patients with ovarian, fallopian tube, or primary peritoneal cysts
• Optional
• Enrollment, 3 months after enrollment, and 6 months after enrollment

Fresh tissue from ovary

Intervention Type: PROCEDURE

• For patients with ovarian, fallopian tube, or primary peritoneal cysts
• Optional
• At time of standard of care surgery

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.

Group Type: EXPERIMENTAL

Integrated psychological care

Intervention Type: BEHAVIORAL

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.

Surveys

Intervention Type: OTHER

• NCCN Distress Thermometer
• PROMIS Depression & Anxiety
• Quality of Life (SF-12)
• Brief COPE
• Patient awareness and satisfaction survey

Blood draw

Intervention Type: PROCEDURE

• For patients with ovarian, fallopian tube, or primary peritoneal cysts
• Optional
• Enrollment, 3 months after enrollment, and 6 months after enrollment

Fresh tissue from ovary

Intervention Type: PROCEDURE

• For patients with ovarian, fallopian tube, or primary peritoneal cysts
• Optional
• At time of standard of care surgery

Interventions

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.

Intervention Type: BEHAVIORAL

Surveys

• NCCN Distress Thermometer
• PROMIS Depression & Anxiety
• Quality of Life (SF-12)
• Brief COPE
• Patient awareness and satisfaction survey

Intervention Type: OTHER

Blood draw

• For patients with ovarian, fallopian tube, or primary peritoneal cysts
• Optional
• Enrollment, 3 months after enrollment, and 6 months after enrollment

Intervention Type: PROCEDURE

Fresh tissue from ovary

• For patients with ovarian, fallopian tube, or primary peritoneal cysts
• Optional
• At time of standard of care surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

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)

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barnes-Jewish Hospital

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Vanderlan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

201711117

Identifier Type: -

Identifier Source: org_study_id