Breast CancerOnPointNCT06534918
Precise Oncology Interventions in Nutrition and Training (OnPoint)
A study testing Fitbit, Nutrition Course: Group Sessions and Physical Activity Program: Group Sessions in people with Breast Cancer and Prostate Cancer, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to see if survivors of breast, prostate, colorectal or lymphoma 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- Fitbit, Nutrition Course: Group Sessions and Physical Activity Program: Group Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 18 years of age or older
- Any sex/gender
- Able to provide consent
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- Able to read/understand English or Spanish
- Diagnosis of breast, prostate, colorectal or lymphoma 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Grey Freylersythe, BS, (305) 243-9832, g.freylersythe@med.miami.edu
Tracy Crane, PhD, RDN, (305) 243-8255, tecrane@med.miami.edu
About this study
The purpose of this study is to see if survivors of breast, prostate, colorectal or lymphoma 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.
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Lymphoma
- Being tested
- Fitbit, Nutrition Course: Group Sessions, Physical Activity Program: Group Sessions, Nutrition Course: One on One Sessions with Registered Dietitian, Physical Activity Program: One on One Sessions with an Exercise Physiologist
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitbitOther
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 SessionsBehavioural
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 SessionsBehavioural
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 DietitianBehavioural
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 PhysiologistBehavioural
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 PrescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Complexity Group | Experimental | Participants in this group will receive the low complexity intervention for up to eight (8) weeks. Receives: Other: Fitbit; Behavioral: Nutrition and Physical Activity Prescription |
| Moderate Complexity Group | Experimental | Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks. Receives: Other: Fitbit; Behavioral: Nutrition Course: Group Sessions; Behavioral: Physical Activity Program: Group Sessions; Behavioral: Nutrition and Physical Activity Prescription |
| High Complexity Group | Experimental | Participants in this group will receive the high complexity intervention for up to eight (8) weeks. Receives: Other: Fitbit; Behavioral: Nutrition Course: One on One Sessions with Registered Dietitian; Behavioral: Physical Activity Program: One on One Sessions with an Exercise Physiologist; Behavioral: Nutrition and Physical Activity Prescription |
| Control Group | No intervention | Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 18 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Survivors Who Agree to Participate
Percentage of survivors who agree to participate will be reported as ≥ 50%.
Measured: Up to 8 Weeks
Percentage of Interventions Sessions Completed
Percentage of intervention sessions completed will be reported as ≥ 80%.
Measured: Up to 8 Weeks
Percentage of Participants Satisfied with the Intervention
Report of 80% satisfaction will be determined as satisfaction with intervention components.
Measured: Up to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start18 Sep 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Applebaum Foundation
- Responsible party
- Principal investigator, Tracy E Crane, PhD, RDN, University of Miami
- Investigators
- Tracy Crane, PhD, RDN, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534918
- Sponsor's protocol ID
- 20230533
- Acronym
- OnPoint
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Oncology Interventions in Nutrition and Training (OnPoint)
- ClinicalTrials.gov ID
- NCT06534918
- Acronym / sponsor ID
- OnPoint / 20230533
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Lymphoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Applebaum Foundation
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if survivors of breast, prostate, colorectal or lymphoma 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Complexity Group | Experimental | Other: Fitbit, Behavioral: Nutrition and Physical Activity PrescriptionParticipants in this group will receive the low complexity intervention for up to eight (8) weeks. |
| Moderate Complexity Group | Experimental | Other: Fitbit, Behavioral: Nutrition Course: Group Sessions, Behavioral: Physical Activity Program: Group Sessions, Behavioral: Nutrition and Physical Activity PrescriptionParticipants in this group will receive the moderate complexity intervention for up to eight (8) weeks. |
| High Complexity Group | Experimental | Other: Fitbit, Behavioral: Nutrition Course: One on One Sessions with Registered Dietitian, Behavioral: Physical Activity Program: One on One Sessions with an Exercise Physiologist, Behavioral: Nutrition and Physical Activity PrescriptionParticipants in this group will receive the high complexity intervention for up to eight (8) weeks. |
| Control Group | No intervention | –Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 18 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- 18 years of age or older
- Any sex/gender
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitbitParticipants 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. | Other | High Complexity Group, Low Complexity Group, Moderate Complexity Group |
| Nutrition Course: Group SessionsThe 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. | Behavioural | Moderate Complexity Group |
| Physical Activity Program: Group SessionsThe 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. | Behavioural | Moderate Complexity Group |
| Nutrition Course: One on One Sessions with Registered DietitianParticipants 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. | Behavioural | High Complexity Group |
| Physical Activity Program: One on One Sessions with an Exercise PhysiologistParticipants 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 | Behavioural | High Complexity Group |
| Nutrition and Physical Activity PrescriptionParticipants 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. | Behavioural | High Complexity Group, Low Complexity Group, Moderate Complexity Group |
Primary outcome
Percentage of Survivors Who Agree to Participate
Time frame: Up to 8 Weeks
Percentage of survivors who agree to participate will be reported as ≥ 50%.
Percentage of Interventions Sessions Completed
Time frame: Up to 8 Weeks
Percentage of intervention sessions completed will be reported as ≥ 80%.
Percentage of Participants Satisfied with the Intervention
Time frame: Up to 8 Weeks
Report of 80% satisfaction will be determined as satisfaction with intervention components.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracy Crane, PhD, RDN principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit, Nutrition Course: Group Sessions and Physical Activity Program: Group Sessions in people with Breast Cancer and Prostate Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grey Freylersythe, BS (305-243-9832, g.freylersythe@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Survivors Who Agree to Participate (time frame: Up to 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.