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Interventions précises en oncologie en nutrition et en formation (OnPoint) (OnPoint)

18 septembre 2026 mis à jour par: Tracy E Crane, PhD, RDN, University of Miami

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

306

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Florida
      • Miami, Florida, États-Unis, 33136
        • Recrutement
        • University of Miami
        • Contact:
        • Contact:
        • Chercheur principal:
          • Tracy Crane, PhD, RDN

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Inclusion Criteria - Healthcare Providers

  1. Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
  2. Utilize the electronic medical record for patient documentation on a regular basis
  3. Willing to complete a 30-60-minute interview

Inclusion Criteria - Patients

  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, colorectal or lymphoma 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:

  1. Less than 18 years of age
  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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Low Complexity Group

Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
Autre: 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.

Comportemental: 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.
Expérimental: Moderate Complexity Group

Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
Autre: 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.

Comportemental: 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.

Comportemental: 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.

Comportemental: 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.
Expérimental: High Complexity Group

Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
Autre: 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.

Comportemental: 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.

Comportemental: 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.

Comportemental: 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
Aucune intervention: 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 18 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Survivors Who Agree to Participate
Délai: Up to 8 Weeks

Percentage of survivors who agree to participate will be reported as ≥ 50%.
Up to 8 Weeks
Percentage of Interventions Sessions Completed
Délai: Up to 8 Weeks

Percentage of intervention sessions completed will be reported as ≥ 80%.
Up to 8 Weeks
Percentage of Participants Satisfied with the Intervention
Délai: Up to 8 Weeks

Report of 80% satisfaction will be determined as satisfaction with intervention components.
Up to 8 Weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Miami

Collaborateurs

The Applebaum Foundation

Les enquêteurs

  • Chercheur principal: Tracy Crane, PhD, RDN, University of Miami

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 septembre 2024

Achèvement primaire (Estimé)

30 septembre 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

30 juillet 2024

Première soumission répondant aux critères de contrôle qualité

30 juillet 2024

Première publication (Réel)

2 août 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20230533

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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