Psychological Services Integration in Gynecological Oncology Clinics
2019년 5월 30일 업데이트: Washington University School of Medicine
Implementation and Evaluation of Psychological Services Integration in Gynecological Oncology Clinics
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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
101
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Arm 1: Usual Care
-No psychosocial care in clinic
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
기간: Completion of patient enrollment (approximately 12 months)
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-Willingness to participate with integrated care as quantified by proportion of enrolled patients from the number of approached eligible patients
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Completion of patient enrollment (approximately 12 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Provider willingness to have a psychologist present
기간: 6 months after start of study enrollment
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-5 item survey about willingness to have psychologist present in clinic
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6 months after start of study enrollment
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Differences in clinic visit duration with and without a psychologist present
기간: Day 1
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-Clinic visit duration is defined as the time from check-in to patient discharge
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Day 1
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Difference in psychological correlates of daily functioning as measured by patient distress between women who receive usual care versus integrated psychological care
기간: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient depression between women who receive usual care versus integrated psychological care
기간: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient anxiety between women who receive usual care versus integrated psychological care
기간: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient quality of life between women who receive usual care versus integrated psychological care
기간: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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Difference in psychological correlates of daily functioning as measured by patient coping mechanisms between women who receive usual care versus integrated psychological care
기간: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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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
기간: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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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
기간: Enrollment, 3 months after enrollment, and 6 months after enrollment
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Enrollment, 3 months after enrollment, and 6 months after enrollment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jessica Vanderlan, Ph.D., Washington University School of Medicine
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 5월 8일
기본 완료 (실제)
2018년 8월 29일
연구 완료 (실제)
2019년 3월 26일
연구 등록 날짜
최초 제출
2018년 3월 21일
QC 기준을 충족하는 최초 제출
2018년 3월 21일
처음 게시됨 (실제)
2018년 3월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 5월 30일
마지막으로 확인됨
2019년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 201711117
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
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아니
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아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .