治験レーダーAI | ||
|---|---|---|
治験 NCT06799481（対象：Cancer-related Cognitive Dysfunction、原発性脳腫瘍）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
検索に戻る
エモリー大学Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
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 NCT06799481 は 介入研究 臨床試験 で、Cancer-related Cognitive Dysfunction、原発性脳腫瘍 に関するものです。現在は 募集中 で、2025年2月13日 から開始しています。60 名の参加者 の募集が計画されています。この治験は エモリー大学 によって主催され、2027年7月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年4月2日 です。
概要
This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.
詳細説明
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of conducting a two-site pilot randomized controlled trial (RCT) to test the RISE in AYA brain tumor survivors.
II. Examine the impact of RISE on CRCI (primary) and physical activity (secondary).
EXPLORATORY OBJECTIVE:
I. Explore the impact of RISE on the gut microbiome diversity and composition.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (RISE INTERVENTION): Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.
ARM II (ATTENTION CONTROL): Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.
After completion of study intervention, patients are followed up at week 18.
公式タイトル
Virtually Delivered Home-Based Exercise Intervention on Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors: A Pilot Randomized Controlled Trial
疾患／病気
Cancer-related Cognitive Dysfunction原発性脳腫瘍その他の研究識別子
- STUDY00008229
- NCI-2025-00181 (登録識別子) (CTRP (Clinical Trial Reporting Program))
- STUDY00008229 (その他の識別子) (Emory University Hospital/Winship Cancer Institute)
- WINSHIP6364-24 (その他の識別子) (Emory University Hospital/Winship Cancer Institute)
- P30CA138292 (米国NIHの助成金/契約)
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
三重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Arm I (RISE) Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12. | 有酸素運動 Participate in personalized, progressive aerobic training 行動介入 Receive active lifestyle behavior coaching インターネットベースの介入 Receive access to Physitrack アンケート管理 Ancillary studies レジスタンストレーニング Participating in strength training exercises |
実薬対照薬Arm II (attention control) Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12. | フォローアップ Receive calls from the trainer 医療機器の使用と評価 Wear a Fitbit monitor アンケート管理 Ancillary studies |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Enrollment | Feasibility will be ≥ 50% enrollment of eligible survivors. Descriptive statistics (e.g., frequency and percentage) will be used. | Up to 1.5 years |
Adherence to research intervention of virtually supervised exercise program (RISE) | Feasibility will be ≥ 75% adherence to RISE. Descriptive statistics (e.g., frequency and percentage) will be used. | Up to 12 weeks |
Retention | Feasibility will be ≥ 80% retention at end of intervention. Descriptive statistics (e.g., frequency and percentage) will be used. | Up to 12 weeks |
Acceptability | Will use an 11-item acceptability questionnaire. A ≥ 4 ("agree" to "strongly agree") per item equates to acceptability. Descriptive statistics (e.g., frequency and percentage) will be used. | Up to 18 weeks |
Change in physical activity levels | Will be measured by Fitbit. Physical activity estimates considered as valid if the monitor is worn ≥ 10 hours/day on ≥ 4 days. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing. | Baseline up to 18 weeks |
Change in cancer-related cognitive impairment | Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing. | Baseline up to 18 weeks |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Gut microbiome | Fecal specimens will be collected for the gut microbiome. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing. | Up to 18 weeks |
Physical function | Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing. | At baseline and at 12 and 18 weeks |
Patient Quality of Life | Will be assessed by Patient Reported Outcomes Measurement Information System-29 recommended. Will use mixed-effect analysis of variance to model the correlation with timepoint and treatment group plus interaction if applicable, clustering on patient to control for repeated measures, and controlling for baseline measure and other covariates, which are considered prognostic or differ at baseline. A 95% level of statistical confidence will be assumed in all statistical testing. | At baseline and at 12 and 18 weeks |
適格基準
対象年齢
小児, 成人
試験の最低年齢
15 Years
対象性別
全て
- Age 15-39 years
- With primary brain tumor with cranial radiotherapy
- 6 months to 4 years post cranial radiotherapy
- Functional Assessment of Cancer Therapy (FACT)-Cognitive Function score < 60 based on self-report (used among AYAs with non-neural cancer)
- Able to provide informed consent/assent
- Able to walk and receive clearance from a provider to participate based on the Physical Activity Readiness Questionnaire
- Currently engaging in < 150 minutes of physical activity per week
- Willing to use smartphone-based applications (app)
- Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain
- Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment
- Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders
エモリー大学402 件のアクティブな治験を探索- アメリカ国立がん研究所3039 件のアクティブな治験を探索
- NRG Oncology
責任者
Jinbing Bai, 研究責任者, Principal Investigator, Emory University
試験中央連絡先
連絡先: Jinbing Bai, PhD, RN, 404-727-2466, [email protected]
1 1カ国の場所
Georgia
Emory University Hospital, Atlanta, Georgia, 30322, United States
Emily Bush, BS, 連絡先, [email protected]
Jinbing Bai, PhD, RN, 研究責任者
募集中