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治験 NCT06534918 (OnPoint)（対象：乳癌、前立腺癌、大腸がん）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。 | ||
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マイアミ大学Precise Oncology Interventions in Nutrition and Training (OnPoint)
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 NCT06534918 (OnPoint) は 介入研究 臨床試験 で、乳癌、前立腺癌、大腸がん に関するものです。現在は 募集中 で、2024年9月18日 から開始しています。306 名の参加者 の募集が計画されています。この治験は マイアミ大学 によって主催され、2027年9月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月19日 です。
概要
The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.
公式タイトル
Precise Oncology Interventions in Nutrition and Training (OnPoint)
疾患／病気
乳癌前立腺癌大腸がんその他の研究識別子
- OnPoint
- 20230533
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
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Low Complexity Group Participants in this group will receive the low complexity intervention for up to eight (8) weeks. | フィットビット Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference. Nutrition and Physical Activity Prescription Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content. |
実験的Moderate Complexity Group Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks. | フィットビット Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference. Nutrition Course: Group Sessions The nutrition course will follow a combined asynchronous and synchronous approach. The asynchronous component will consist of a pre-recorded session covering educational nutrition content, which will be made available to participants for self-paced learning. This will be followed by a synchronous, 30-60 minute live group education class on nutrition information for cancer survivors, held once per week. Physical Activity Program: Group Sessions The Physical Activity Program will be held virtually or in-person. This will be a 1-hour biweekly group education class on aerobic and resistance exercise recommendations for cancer survivors. Nutrition and Physical Activity Prescription Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content. |
実験的High Complexity Group Participants in this group will receive the high complexity intervention for up to eight (8) weeks. | フィットビット Participants will be provided with a Fitbit. Self-reported physical activity, location, vital sign and sleep stage information will be collected and monitored every day for up to eight (8) weeks. Data will be synced to the My Wellness Research Software Platform, resulting in a weekly text or phone call check-in, based on participants preference. Nutrition Course: One on One Sessions with Registered Dietitian Participants will be referred to weekly one on one nutrition counseling sessions with a Registered Dietitian. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual. Physical Activity Program: One on One Sessions with an Exercise Physiologist Participants will be referred to weekly one on one exercise training sessions with an Exercise Physiologist. The one on one sessions are anticipated to last 30-60 minutes, based on the needs of the individual Nutrition and Physical Activity Prescription Participants will receive a lifestyle medicine prescription pad, developed by the investigators, which serves as a checklist to assist participants in effectively monitoring their dietary habits and physical activity routines. Participants will also receive an 8-week text messages program which will direct participants to a webpage with nutrition and physical activity content. |
非介入Control Group Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 24 weeks. | 該当なし |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of Survivors Who Agree to Participate | Percentage of survivors who agree to participate will be reported as ≥ 50%. | Up to 8 Weeks |
Percentage of Interventions Sessions Completed | Percentage of intervention sessions completed will be reported as ≥ 80%. | Up to 8 Weeks |
Percentage of Participants Satisfied with the Intervention | Report of 80% satisfaction will be determined as satisfaction with intervention components. | Up to 8 Weeks |
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
全て
健康なボランティアを受け入れる
はい
Inclusion Criteria - Healthcare Providers
- Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
- Utilize the electronic medical record for patient documentation on a regular basis
- Willing to complete a 30-60-minute interview
Inclusion Criteria - Patients
- 18 years of age or older
- Any sex/gender
- Able to provide consent
- Able to read/understand English or Spanish
- Diagnosis of breast, prostate or colorectal cancer, 6 months post completion of primary treatment, with no evidence of primary disease
- Approval from treating oncologist, confirmed via email or in writing
- Fail to meet at least one of the American Cancer Society guidelines: engaging in >150 minutes of moderate-to-vigorous physical activity per week for the prior month or consuming at least 3 cups of vegetables and 2 cups of fruit per day over the past month.
- Internet access on a smart phone, tablet, or computer
- Agree to be randomly assigned to any study group
- Less than 18 years of age
- Unable to provide consent
- Unable to read/understand English or Spanish
- Any contraindication for diet change or exercising as determined by physician
- Blank
- Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
- Meeting the American Cancer Society diet recommendations (3 cups of vegetables or legumes, 2 cups of fruit, 2 serving whole grain per day, and limited red/processed meats, sugar-sweetened beverages, and highly processed foods) for the prior month
- History of dementia or major psychiatric disease which would interfere with study participation
- History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
- Eastern Cooperative Oncology Group (ECOG) score of >2
- Severe lymphedema as determined by physician
- Receiving physical therapy treatment
マイアミ大学289 件のアクティブな治験を探索The Applebaum Foundation責任者
Tracy E Crane, PhD, RDN, 研究責任者, Associate Professor, University of Miami
試験中央連絡先
連絡先: Grey Freylersythe, BS, 305-243-9832, [email protected]
連絡先: Tracy Crane, PhD, RDN, 305-243-8255, [email protected]
1 1カ国の場所
Florida
University of Miami, Miami, Florida, 33136, United States
Grey Freylersythe, BS, 連絡先, 305-243-9832, [email protected]
Tracy Crane, PhD, RDN, 連絡先, (305) 243-8255, [email protected]
Tracy Crane, PhD, RDN, 研究責任者
募集中