Precise Oncology Interventions in Nutrition and Training (OnPoint)
NCT ID: NCT06534918
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
306 participants
INTERVENTIONAL
2024-09-18
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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 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.
Eligibility Criteria
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Inclusion Criteria
2. Utilize the electronic medical record for patient documentation on a regular basis
3. Willing to complete a 30-60-minute interview
1. 18 years of age or older
2. Any sex/gender
3. Able to provide consent
4. Able to read/understand English or Spanish
5. Diagnosis of breast, prostate or colorectal cancer, 6 months post completion of primary treatment, with no evidence of primary disease
6. Approval from treating oncologist, confirmed via email or in writing
7. 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.
8. Internet access on a smart phone, tablet, or computer
9. Agree to be randomly assigned to any study group
Exclusion Criteria
2. Unable to provide consent
3. Unable to read/understand English or Spanish
4. Any contraindication for diet change or exercising as determined by physician
5. Blank
6. Engaging in \>150 minutes of moderate to vigorous physical activity on average per week for the prior month
7. 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
8. History of dementia or major psychiatric disease which would interfere with study participation
9. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
10. Eastern Cooperative Oncology Group (ECOG) score of \>2
11. Severe lymphedema as determined by physician
12. Receiving physical therapy treatment
18 Years
ALL
Yes
Sponsors
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The Applebaum Foundation
UNKNOWN
University of Miami
OTHER
Responsible Party
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Tracy E Crane, PhD, RDN
Associate Professor
Principal Investigators
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Tracy Crane, PhD, RDN
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20230533
Identifier Type: -
Identifier Source: org_study_id
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