Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
The purpose of this study is to evaluate the efficacy of the standardized care pathway which provides enhanced supportive care for patients with advanced cancer.
A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of applying standardized care pathway to provide enhanced supportive care. A Randomized Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to intervention arm (receiving enhanced supportive care according to the standardized care pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the intervention arm will receive enhanced supportive care consisted of symptom management and coping enhancement counseling for 5 times. Data from advanced cancer patients will be collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm), at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as advanced cancer patients' symptom, coping and quality of life.
調査の概要
状態
条件
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jiyeon Lee, Ph.D
- 電話番号：82-2-2228-3255
- メール：jiyeonest@yuhs.ac
研究場所
-
-
-
Seoul、大韓民国
- 募集
- Yonsei University
-
コンタクト：
- Jiyeon Lee, Ph.D
- 電話番号：82-2-2228-3255
- メール：jiyeonest@yuhs.ac
-
-
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:
- adult (age >=19 years old),
- cancer patients and their family
- ECOG =<2
Exclusion Criteria:
- patients with cognitive or psychiatric issue
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：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 |
|---|---|
|
実験的：A
Experimental group with application of the standardized care pathways and symptom management education
|
Enhanced supportive care based on standard care pathway is consisted of 1) symptom management (symptom assessment and according management) and 2) coping enhancement (nurse-led counseling).
The enhanced supportive care will be provided 5 times, according to the standardized care pathway.
|
|
他の：B
Control group with usual care (symptom monitoring only)
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Control group will receive usual care (symptom monitoring only)
|
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 |
時間枠 |
|---|---|
|
Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
時間枠：at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)
|
at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)
|
|
Coping measured by brief COPE
時間枠：at the visit for cycle 5 of chemotherapy (at average 3 month)
|
at the visit for cycle 5 of chemotherapy (at average 3 month)
|
|
Quality of life measured by the EORTC QLQ C-30
時間枠：at the visit for cycle 5 of chemotherapy (at average 3 month)
|
at the visit for cycle 5 of chemotherapy (at average 3 month)
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
時間枠：at the visit for cycle 5 of chemotherapy (at average 3 month)
|
at the visit for cycle 5 of chemotherapy (at average 3 month)
|
|
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
時間枠：at 6 month
|
at 6 month
|
|
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
時間枠：at the visit for cycle 5 of chemotherapy (at average 3 month)
|
at the visit for cycle 5 of chemotherapy (at average 3 month)
|
|
Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
時間枠：at 6 month
|
at 6 month
|
|
Self-efficacy measured by the Cancer Behavior Inventory 3.0
時間枠：at the visit for cycle 5 of chemotherapy (at average 3 month)
|
at the visit for cycle 5 of chemotherapy (at average 3 month)
|
|
Self-efficacy measured by the Cancer Behavior Inventory 3.0
時間枠：at 6 month
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at 6 month
|
|
Survival
時間枠：at 6 month
|
at 6 month
|
|
Survival
時間枠：at 12 month
|
at 12 month
|
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Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
時間枠：at 6 month
|
at 6 month
|
|
Coping measured by brief COPE
時間枠：at 6 month
|
at 6 month
|
|
Quality of life measured by the EORTC QLQ C-30
時間枠：at 6 month
|
at 6 month
|
|
Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month
時間枠：At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
|
At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
|
|
Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month
時間枠：At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
|
At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
- 4-2020-0304
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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