ReStOre@Home: Feasibility Study of a 12-week Multidisciplinary Telehealth Rehabilitation Programme for Survivors of Upper Gastrointestinal (UGI) Cancer (ReStOre@Home)
調査の概要
詳細な説明
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
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Leinster
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Dublin、Leinster、アイルランド
- Trinity College Dublin
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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:
- be ≥ three months post oesophagectomy, total gastrectomy
- ± neo-adjuvant/adjuvant chemo/chemoradiotherapy with curative intent
- adjuvant therapy must be completed
- access to home broadband
Exclusion Criteria:
- Ongoing serious post-operative morbidity
- Evidence of active or recurrent disease.
In addition those with any serious co-morbidity that would impact on exercise participation will be excluded including those with;
- Uncontrolled hypertension (resting systolic blood pressure >180mmHg and/or diastolic >100mmHg)
- Recent serious cardiovascular events (within 12 months) including, but not limited to cerebrovascular accident, and myocardial infarction
- Unstable cardiac, renal, lung, liver or other severe chronic disease
- Uncontrolled atrial fibrillation
- Left ventricular function <50%.
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:処理
- 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 |
|---|---|
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実験的:Intervention Arm
Single arm trial, all participants will receive the intervention
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12 week programme of; 1) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions |
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 - Recruitment
時間枠:Through study completion approx 1 year
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Feasibility will be determined by recruitment rate, the number of eligible participants who consent to participation.
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Through study completion approx 1 year
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Feasibility - adherence
時間枠:From baseline (T0) to immediately after the program intervention (T1)
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Feasibility will also be determined by adherence to the trial intervention, the number of prescribed intervention sessions completed.
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From baseline (T0) to immediately after the program intervention (T1)
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Feasibility - acceptability of the intervention (1)
時間枠:Immediately after the program intervention (T1)
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Feasibility will also be determined by the acceptability of the programme. Acceptability of the telehealth programme will be assessed by the Telehealth Usability Questionnaire (TUQ). The Telehealth Usability scale is a 5 point likert scale where 1 = completely disagree, and 5 =fully agree, Higher ratings indicate better usability. |
Immediately after the program intervention (T1)
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Feasibility - acceptability of the intervention (2)
時間枠:Duration of the trial i.e. From enrolment of the first participant until completion of the final participants post-intervention assessment (Time period of up to 12 months).
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Acceptability of the intervention will be further determined by a qualitative approach.Interviews will be carried out with participants post-intervention to gain their perspectives of the impact of the program on physical and mental well-being and the suitability of the programme to delivery via telehealth
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Duration of the trial i.e. From enrolment of the first participant until completion of the final participants post-intervention assessment (Time period of up to 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 |
|---|---|---|
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Change in Cardiorespiratory Fitness from Baseline
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Cardiorespiratory fitness will be determined by Cardiopulmonary Exercise Test (CPET)
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Baseline (T0), Immediately after the program intervention (T1)
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Physical Performance
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Physical Performance will be measured with the Short Physical Performance Battery
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Baseline (T0), Immediately after the program intervention (T1)
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Hand Grip Strength
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Hand Grip strength will be measured with hand held dynamometry
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Baseline (T0), Immediately after the program intervention (T1)
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Physical Activity
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Physical activity will be measured using the Godin Shepherd Leisure-Time Exercise Questionnaire.
A score of 24 indicates the individual is active, 14-23 indicates moderately active, and less than 14 indicates sedentary/ insufficiently active.
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Baseline (T0), Immediately after the program intervention (T1)
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Weight
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Weight will be recorded by standard measures and reported in kilograms (kg).
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Baseline (T0), Immediately after the program intervention (T1)
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Height
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Height will be recorded by standard measures and reported in meters (m)
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Baseline (T0), Immediately after the program intervention (T1)
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Body Mass Index
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Body Mass Index (BMI) will be calculated as weight (kg)/height (meters(m2)) and reported in kilograms/metres squared (kg/m2).
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Baseline (T0), Immediately after the program intervention (T1)
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Circumferential Measurements
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Mid-arm circumference and waist circumference will be measured with a flexible tape measure and reported in centimeters (cm)
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Baseline (T0), Immediately after the program intervention (T1)
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Health Related Quality of Life measured by the European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Quality of Life will be determined by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30). Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden. |
Baseline (T0), Immediately after the program intervention (T1)
|
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Oesophago-gastric cancer specific Health Related Quality of Life will measured by the European Organisation for the Research and Treatment of Cancer Oesophago-gastric Cancer Subscale the EORTC-QLQ-OG25.
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Oesophagogastric cancer specific quality of life will be determined by the EORTC-QLQ-OG25 subscale. Scores are reported on a linear scale from 0-100. A high score in a functional scale indicates greater function. A high score in a symptom scale indicates greater symptom burden. |
Baseline (T0), Immediately after the program intervention (T1)
|
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Fatigue
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Fatigue will be assessed using the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
It is scored from 0-20.
A cut off score of >or =13 indicates severe fatigue.
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Baseline (T0), Immediately after the program intervention (T1)
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Bio-sample Collection
時間枠:Baseline (T0), Immediately after the program intervention (T1)
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Serum, Plasma and Whole Blood samples will be collected at each time-point to establish a survivorship Biobank for UGI cancer.
These samples will be stored in the biobank for future to be determined studies.
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Baseline (T0), Immediately after the program intervention (T1)
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協力者と研究者
出版物と役立つリンク
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
その他の研究ID番号
- DIFA-2018-009 - ReStOre@Home
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
米国で製造され、米国から輸出された製品。
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