Psychological Services Integration in Gynecological Oncology Clinics
2019年5月30日 更新者：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.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
101
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Arm 1: Usual Care
-No psychosocial care in clinic
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of integrating psychosocial care by a trained psychologist into gynecologic cancer outpatient clinics as measured by patient enrollment
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Provider willingness to have a psychologist present
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jessica Vanderlan, Ph.D.、Washington University School of Medicine
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年5月8日
一次修了 (実際)
2018年8月29日
研究の完了 (実際)
2019年3月26日
試験登録日
最初に提出
2018年3月21日
QC基準を満たした最初の提出物
2018年3月21日
最初の投稿 (実際)
2018年3月29日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月3日
QC基準を満たした最後の更新が送信されました
2019年5月30日
最終確認日
2019年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 201711117
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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