Clinical trial NCT03481127: Psychological Services Integration in Gynecological Oncology Clinics
Official title: Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gynecologic Oncology Patient
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
First posted: 2018-03-29
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
timeFrame: Completion of patient enrollment (approximately 12 months)
Secondary outcomes:
measure: Provider willingness to have a psychologist present
timeFrame: 6 months after start of study enrollment
measure: Differences in clinic visit duration with and without a psychologist present
timeFrame: Day 1
measure: Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care
timeFrame: Enrollment, 3 months after enrollment, and 6 months after enrollment
measure: Difference in psychological correlates of daily functioning as measured by patient depression between women who receive usual care versus integrated psychological care
timeFrame: Enrollment, 3 months after enrollment, and 6 months after enrollment
measure: Difference in psychological correlates of daily functioning as measured by patient anxiety between women who receive usual care versus integrated psychological care
timeFrame: Enrollment, 3 months after enrollment, and 6 months after enrollment
measure: Difference in psychological correlates of daily functioning as measured by patient quality of life between women who receive usual care versus integrated psychological care
timeFrame: Enrollment, 3 months after enrollment, and 6 months after enrollment
measure: Difference in psychological correlates of daily functioning as measured by patient coping mechanisms between women who receive usual care versus integrated psychological care
timeFrame: Enrollment, 3 months after enrollment, and 6 months after enrollment
measure: 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
timeFrame: Enrollment, 3 months after enrollment, and 6 months after enrollment
measure: 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
timeFrame: Enrollment, 3 months after enrollment, and 6 months after enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jessica Vanderlan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: