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Clinical Trials/NCT03481127
NCT03481127
Completed
Phase 1

Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics

Washington University School of Medicine1 site in 1 country101 target enrollmentMay 8, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Gynecologic Oncology Patient
Sponsor
Washington University School of Medicine
Enrollment
101
Locations
1
Primary Endpoint
Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2018
End Date
March 26, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • 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.

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)
  • 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.

Outcomes

Primary Outcomes

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

Time Frame: Completion of patient enrollment (approximately 12 months)

-Willingness to participate with integrated care as quantified by proportion of enrolled patients from the number of approached eligible patients

Secondary Outcomes

  • 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 anxiety 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 quality of life between women who receive usual care versus integrated psychological care(Enrollment, 3 months after enrollment, and 6 months after enrollment)
  • 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 perception of psychological care as measured by patient perception of Siteman Cancer Center being highly focused on their wellbeing 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 awareness of psychological care as measured by awareness of support services offered 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 coping mechanisms between women who receive usual care versus integrated psychological care(Enrollment, 3 months after enrollment, and 6 months after enrollment)

Study Sites (1)

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