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治験 NCT05704842（対象：乳癌）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05704842 は 介入研究 臨床試験 で、乳癌 に関するものです。現在は 募集中 で、2022年12月22日 から開始しています。40 名の参加者 の募集が計画されています。この治験は Virtua Health, Inc. によって主催され、2026年6月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2024年4月5日 です。
概要
Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.
詳細説明
The goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (CRF) in breast cancer patients undergoing curative-intent chemotherapy. The outcome will be measured by using the FACIT Fatigue Scale, administered by using the Carevive PROmpt® platform.
Primary Objectives:
- . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
- To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
- To compute the means and standard deviations (SD) of the FACIT responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing RCT.
Secondary Objectives:
- To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
- To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis
公式タイトル
Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy
疾患／病気
乳癌その他の研究識別子
- IRB-2021-04
主目的
その他
割付方法
無作為化
介入モデル
ファクトリアル割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
その他Exercise Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. | 運動 Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. |
非介入Control Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | The outcome will be measured by using the FACIT Fatigue Scale 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Baseline |
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Weekly for 12 weeks |
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Month 1 following completion of chemotherapy |
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Month 3 following completion of chemotherapy |
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Month 6 following completion of chemotherapy |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
To quantify the change over time in PRO-CTCAE derived symptoms | Outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following sale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Baseline |
To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Weekly for 12 weeks |
To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Month 1 following completion of chemotherapy |
To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Month 3 following completion of chemotherapy |
To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Month 6 following completion of chemotherapy |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
女性
- Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.
- Age > 18 years
- ECOG performance score < 3
- English-speaking
- with sufficient vision/hearing or family support
- Coronary artery disease, if cleared by cardiologist
- Subject must have smart phone, computer or tablet.
- Willingness to be randomized
- Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions).
- Patients with overt evidence of a psychiatric disorder.
- Coronary artery disease, not cleared by cardiologist.
- Contraindication to exercise.
- Chronic fatigue syndrome.
Virtua Health, Inc.Carevive Systems, Inc.試験中央連絡先
連絡先: Susan VanLoon, RN, CCRP, 8562477382, [email protected]
1 1カ国の場所
New Jersey
Virtua Health, Voorhees Township, New Jersey, 08043, United States
Susan VanLoon, RN, CCRP, 連絡先, 856-247-7382, [email protected]
募集中