再発性ステージ III ～ IV の胸部悪性腫瘍の参加者とその介護者の症状管理における緩和ケアの組み込み
進行性胸部悪性腫瘍の管理における緩和ケアの組み込み
This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVES:
I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.
II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.
III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.
IV. To analyze health care utilization among participants receiving embedded onco-palliative care.
OUTLINE:
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.
After completion of study, patients are followed for up to 1 year.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage III or IV, recurrent disease
- Patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at The Ohio State University
- New patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies
- Patient and caregiver must be able to read and understand consent form
- Patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation
Exclusion Criteria:
- Patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. Inpatient palliative care consultation prior to enrollment is permitted
- Patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment
- Patients who are unable to read or understand consent form
- Patients receiving primary systemic treatment outside of Ohio State. Outside radiation therapy is permitted
研究計画
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：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Supportive care (embedded palliative care)
Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit. |
Ancillary studies Undergo embedded palliative care
他の名前：
|
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 |
|---|---|---|
|
Acceptance from providers to assess utilization of palliative care services
時間枠：Up to 12 months
|
Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Demand of palliative care services to be evaluated
時間枠：Up to 12 months
|
Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Capacity and productivity to be evaluated
時間枠：Up to 12 months
|
Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Resource assessment of staff and space
時間枠：Up to 12 months
|
Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates. |
Up to 12 months
|
|
Symptom burden (patient outcome) supportive care screen
時間枠：Up to 12 months
|
Will be assessed using Supportive care screen. |
Up to 12 months
|
|
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
時間枠：Up to 12 months
|
Will be assessed using Functional Assessment of Cancer Therapy-Lung |
Up to 12 months
|
|
Symptom burden (patient outcome) using HADS
時間枠：Up to 12 months
|
Will be assessed using Hospital Anxiety and Depression Scale (HADS) |
Up to 12 months
|
|
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
時間枠：Up to 12 months
|
Will be assessed using National Comprehensive Cancer Network distress thermometer |
Up to 12 months
|
|
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
時間枠：Up to 12 months
|
Anxiety assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
|
|
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
時間枠：Up to 12 months
|
Depression assessed using the Hospital Anxiety and Depression Scale |
Up to 12 months
|
|
Functional status assessed using Functional Activities Scale (patient outcome)
時間枠：Up to 12 months
|
Functional status assessment using Functional Activities Scale (FAS) |
Up to 12 months
|
|
Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
時間枠：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
時間枠：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
時間枠：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Information needs assessed using SCNS- P and C (Caregiver outcome)
時間枠：Up to 12 months
|
Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C) |
Up to 12 months
|
|
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
時間枠：Up to 12 months
|
Ohio State Palliative Care Provider survey used to assess perceived barriers to referral |
Up to 12 months
|
|
Health care utilization outcomes
時間枠：Up to 12 months
|
Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events. |
Up to 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model
時間枠：Up to 12 months
|
evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care |
Up to 12 months
|
協力者と研究者
捜査官
- 主任研究者：Carolyn Presley, MD、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- OSU-18116
- NCI-2018-01209 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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?
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
米国FDA規制機器製品の研究
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