试验雷达 AI | ||
|---|---|---|
临床试验 NCT06534918 (OnPoint) 针对乳腺癌，前列腺癌，结直肠癌目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
返回搜索
迈阿密大学Precise Oncology Interventions in Nutrition and Training (OnPoint)
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“解释临床试验”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06534918 (OnPoint)是一项针对乳腺癌，前列腺癌，结直肠癌的干预性研究试验，目前试验状态为招募中。试验始于2024年9月18日，计划招募306名患者。该研究由迈阿密大学主导，预计于2027年9月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月19日。
简要概括
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.
官方标题
Precise Oncology Interventions in Nutrition and Training (OnPoint)
疾病
乳腺癌前列腺癌结直肠癌其他研究标识符
- OnPoint
- 20230533
NCT编号
实际开始日期
2024-09-18
最近更新发布
2025-09-19
预计完成日期
2027-09-30
计划入组人数
306
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
主要目的
支持治疗
分配方式
随机
干预模型
平行
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Low Complexity Group Participants in this group will receive the low complexity intervention for up to eight (8) weeks. | FitBit 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. |
实验性Moderate Complexity Group Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks. | FitBit 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. |
实验性High Complexity Group Participants in this group will receive the high complexity intervention for up to eight (8) weeks. | FitBit 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. |
无干预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. | 不适用 |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
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
迈阿密大学290 个活跃的临床试验可供探索The Applebaum Foundation研究责任方
Tracy E Crane, PhD, RDN, 主要研究者, Associate Professor, University of Miami
研究中心联系人
联系人: Grey Freylersythe, BS, 305-243-9832, [email protected]
联系人: Tracy Crane, PhD, RDN, 305-243-8255, [email protected]
1 位于 1 个国家/地区的研究中心
Florida
University of Miami, Miami, Florida, 33136, United States
Grey Freylersythe, BS, 联系人, 305-243-9832, [email protected]
Tracy Crane, PhD, RDN, 联系人, (305) 243-8255, [email protected]
Tracy Crane, PhD, RDN, 主要研究者
招募中