- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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.
|
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.
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
|
Questionnaire
Tidsramme: At conclusion of 12 week study period
|
Participant satisfaction
|
At conclusion of 12 week study period
|
Questionnaire
Tidsramme: At conclusion of 12 week study period
|
Intervention preferences
|
At conclusion of 12 week study period
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
DNA methylation
Tidsramme: At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
Serum cytokines
Tidsramme: At beginning and end of 12 week study period
|
At beginning and end of 12 week study period
|
|
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
|
At beginning and end of 12 week study period
|
|
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
|
|
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)
|
At beginning of 12 week study period
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Laura Q. Rogers, MD, University of Alabama at Birmingham
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- X140813004
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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