- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of patients excluded or not agreeing to participate
Tidsramme: Baseline
|
Feasibility measure
|
Baseline
|
Adherence to study protocol activities (research records and diet intake self-report)
Tidsramme: Throughout 12 week study period
|
Feasibility measure (e.g., percent of assessments completed, percent of counseling phone calls completed, servings of cruciferous vegetables eaten, etc.)
|
Throughout 12 week study period
|
Attrition rates
Tidsramme: Throughout 12 week study period
|
Feasibility measure
|
Throughout 12 week study period
|
Adverse events with reporting according to institutional review board policy
Tidsramme: Throughout 12 week study period
|
Throughout 12 week study period
|
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Questionnaire
Tidsramme: At conclusion of 12 week study period
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Participant satisfaction
|
At conclusion of 12 week study period
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Questionnaire
Tidsramme: At conclusion of 12 week study period
|
Intervention preferences
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At conclusion of 12 week study period
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
DNA methylation
Tidsramme: 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
Tidsramme: At beginning and end of 12 week study period
|
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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Laura Q. Rogers, MD, University of Alabama at Birmingham
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- X140813004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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Karolinska InstitutetAktiv, ikke rekrutterendeBørnemishandling | BørnemishandlingSverige
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University of VermontAfsluttet
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