Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1: Usual Care
-No psychosocial care in clinic
干预措施: Surveys (Other)
Arm 1: Usual Care
-No psychosocial care in clinic
干预措施: Blood draw (Procedure)
Arm 1: Usual Care
-No psychosocial care in clinic
干预措施: Fresh tissue from ovary (Procedure)
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.
干预措施: Integrated psychological care (Behavioral)
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.
干预措施: Surveys (Other)
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.
干预措施: Blood draw (Procedure)
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.
干预措施: Fresh tissue from ovary (Procedure)
结局指标
主要结局
Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
时间窗: 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
次要结局
- 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)