Präzise onkologische Interventionen in Ernährung und Training (OnPoint) (OnPoint)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Sonstiges: Fitbit
- Verhalten: Nutrition and Physical Activity Prescription
- Verhalten: Nutrition Course: Group Sessions
- Verhalten: Physical Activity Program: Group Sessions
- Verhalten: Nutrition Course: One on One Sessions with Registered Dietitian
- Verhalten: Physical Activity Program: One on One Sessions with an Exercise Physiologist
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Grey Freylersythe, BS
- Telefonnummer: 305-243-9832
- E-Mail: g.freylersythe@med.miami.edu
Studieren Sie die Kontaktsicherung
- Name: Tracy Crane, PhD, RDN
- Telefonnummer: 305-243-8255
- E-Mail: tecrane@med.miami.edu
Studienorte
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33136
- Rekrutierung
- University of Miami
-
Kontakt:
- Grey Freylersythe, BS
- Telefonnummer: (305) 243-9832
- E-Mail: g.freylersythe@med.miami.edu
-
Kontakt:
- Tracy Crane, PhD, RDN
- Telefonnummer: (305) 243-8255
- E-Mail: tecrane@med.miami.edu
-
Hauptermittler:
- Tracy Crane, PhD, RDN
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
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, 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
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Low Complexity Group
Participants in this group will receive the low complexity intervention for up to eight (8) weeks. |
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. 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. |
|
Experimental: Moderate Complexity Group
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks. |
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. 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. 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. 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. |
|
Experimental: High Complexity Group
Participants in this group will receive the high complexity intervention for up to eight (8) weeks. |
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. 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. 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. 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 |
|
Kein Eingriff: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of Survivors Who Agree to Participate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 8 Weeks
|
Report of 80% satisfaction will be determined as satisfaction with intervention components. |
Up to 8 Weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Tracy Crane, PhD, RDN, University of Miami
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Genitale Neubildungen, männlich
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Genitalerkrankungen, männlich
- Prostataerkrankungen
- Männliche Urogenitalerkrankungen
- Darmerkrankungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Erkrankungen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Darmerkrankungen
- Hautkrankheiten
- Brusterkrankungen
- Lymphatische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Haut- und Bindegewebserkrankungen
- Hämische und lymphatische Krankheiten
- Prostataneoplasmen
- Kolorektale Neubildungen
- Neoplasien der Brust
- Lymphom
- Ernährung, Nahrung und Ernährung
- Physiologische Phänomene
- Ernährung physiologische Phänomene
- Bevölkerungseigenschaften
- Gesundheitszustand
- Demographie
- Ernährungsstatus
Andere Studien-ID-Nummern
- 20230533
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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