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Lo studio clinico NCT06534918 (OnPoint) per Cancro al seno, CANCRO ALLA PROSTATA, Cancro colo-rettale è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Università di MiamiPrecise Oncology Interventions in Nutrition and Training (OnPoint)
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06534918 (OnPoint) è uno studio interventistico per Cancro al seno, CANCRO ALLA PROSTATA, Cancro colo-rettale, attualmente in arruolamento. Avviato il 18 settembre 2024, prevede di arruolare 306 partecipanti. Sotto la guida di l'Università di Miami, dovrebbe concludersi entro il 30 settembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 19 settembre 2025.
Sommario breve
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.
Titolo ufficiale
Precise Oncology Interventions in Nutrition and Training (OnPoint)
Condizioni
Cancro al senoCANCRO ALLA PROSTATACancro colo-rettaleAltri ID dello studio
- OnPoint
- 20230533
Numero NCT
Data di inizio (effettiva)
2024-09-18
Ultimo aggiornamento pubblicato
2025-09-19
Data di completamento (stimata)
2027-09-30
Arruolamento (previsto)
306
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Terapia di supporto
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleLow 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. |
SperimentaleModerate 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. |
SperimentaleHigh 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. |
Nessun interventoControl 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. | N.D. |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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 |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
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
Università di Miami290 studi clinici attivi da esplorareThe Applebaum FoundationParte responsabile dello studio
Tracy E Crane, PhD, RDN, Investigatore principale, Associate Professor, University of Miami
Contatti principali dello studio
Contatto: Grey Freylersythe, BS, 305-243-9832, [email protected]
Contatto: Tracy Crane, PhD, RDN, 305-243-8255, [email protected]
1 Centri dello studio in 1 paesi
Florida
University of Miami, Miami, Florida, 33136, United States
Grey Freylersythe, BS, Contatto, 305-243-9832, [email protected]
Tracy Crane, PhD, RDN, Contatto, (305) 243-8255, [email protected]
Tracy Crane, PhD, RDN, Investigatore principale
In arruolamento