Psychological Services Integration in Gynecological Oncology Clinics

NCT03481127 | Completed Phase 1 DMC

• 1 other identifier: 201711117
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment

  -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 Outcomes (9)

• Provider willingness to have a psychologist present

  6 months after start of study enrollment

• Differences in clinic visit duration with and without a psychologist present

  Day 1

• Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care

  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

  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

  Enrollment, 3 months after enrollment, and 6 months after enrollment

Study Arms (2)

Arm 1: Usual Care

ACTIVE COMPARATOR

-No psychosocial care in clinic

Other: Surveys; Procedure: Blood draw; Procedure: Fresh tissue from ovary

Arm 2: Integrated Care

EXPERIMENTAL

-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.

Behavioral: Integrated psychological care; Other: Surveys; Procedure: Blood draw; Procedure: Fresh tissue from ovary

Interventions

Integrated psychological care 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.

Arm 2: Integrated Care

Surveys OTHER

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

Arm 1: Usual Care; Arm 2: Integrated Care

Blood draw PROCEDURE

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

Arm 1: Usual Care; Arm 2: Integrated Care

Fresh tissue from ovary PROCEDURE

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

Arm 1: Usual Care; Arm 2: Integrated Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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)
• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Jessica Vanderlan, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 29, 2018
• Study Start: May 8, 2018
• Primary Completion: August 29, 2018
• Study Completion: March 26, 2019
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)