- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03013699
Diet Intervention, Head and Neck Cancer, Feasibility
Improving Dietary Patterns in Head and Neck Cancer Survivors to Optimize Disease Outcomes and Supportive Care: A Pilot/Feasibility Intervention Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Patients will be eligible to participate if they are 1) diagnosed with Stage I - IV oral, hypopharyngeal, nasopharyngeal, oropharyngeal, or laryngeal cancer; 2) age 19+; 3) at least 6 months - 2 years post-treatment; 4) able to consume foods orally; 5) no evidence of disease; 6) English-speaking
Exclusion Criteria:
Patients will not be eligible to participate if they have 1) dementia or organic brain syndrome; 2) severe emotional distress; 3) active schizophrenia; 3) another diagnosis of cancer in the past five years (not including skin or cervical cancer in situ)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: Usual Dietary Care
Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
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Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
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Experimenteel: Cruciferous and Dark Leafy Green Intervention
Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.
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Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of patients excluded or not agreeing to participate
Tijdsspanne: Baseline
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Feasibility measure
|
Baseline
|
Adherence to study protocol activities (research records and diet intake self-report)
Tijdsspanne: Throughout 12 week study period
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Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)
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Throughout 12 week study period
|
Attrition rates
Tijdsspanne: Throughout 12 week study period
|
Feasibility measure
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Throughout 12 week study period
|
Adverse events with reporting according to institutional review board policy
Tijdsspanne: Throughout 12 week study period
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Throughout 12 week study period
|
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Questionnaire
Tijdsspanne: At conclusion of 12 week study period
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Participant satisfaction
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At conclusion of 12 week study period
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Questionnaire
Tijdsspanne: At conclusion of 12 week study period
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Intervention preferences
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At conclusion of 12 week study period
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
DNA methylation
Tijdsspanne: At beginning and end of 12 week study period
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At beginning and end of 12 week study period
|
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Serum cytokines
Tijdsspanne: At beginning and end of 12 week study period
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At beginning and end of 12 week study period
|
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Quality of life (assessed using the Functional Assessment of Cancer Therapy Head and Neck index)
Tijdsspanne: At beginning and end of 12 week study period
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At beginning and end of 12 week study period
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Total energy and nutrient intakes
Tijdsspanne: At beginning and end of 12 week study period
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At beginning and end of 12 week study period
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Covariates
Tijdsspanne: At beginning of 12 week study period
|
A questionnaire will collect a set of covariates used in the analyses (i.e., these do not represent individual outcomes; this is a group of covariates used in the data analyses).
This group includes demographic characteristics (age, sex, race, ethnicity, education, income); lifestyle behaviors (tobacco use, alcohol consumption, exercise); medical history; cancer-specific clinical variables (tumor site, cancer stage, treatment modality); anthropometrics (height and weight)
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At beginning of 12 week study period
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Laura Q. Rogers, MD, University of Alabama At Birmingham
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- X140813004
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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