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Håndtering af kræftoverleveres ernæringsmæssige behov med ernæringsusikkerhed

29. maj 2026 opdateret af: University of California, San Francisco
Dette kliniske forsøg undersøger, om brugen af ​​en dagligvareleveringstjeneste (Instacart) og ernæringsnavigation forbedrer fødevareusikkerheden hos kræftoverlevere. American Cancer Society anbefaler et normalt kropsmasseindeks, regelmæssig fysisk aktivitet og en sund kost til kræftpatienter. At følge disse retningslinjer kan hjælpe med at forhindre dødsfald blandt kræftpatienter, men få kræftpatienter følger dem. En grund til ikke at følge retningslinjerne kan skyldes manglen på konsekvent adgang til tilstrækkelige mængder af økonomisk overkommelig, nærende mad til et aktivt, sundt liv (fødevareusikkerhed). Instacart giver brugerne adgang til fødevarer, der falder ind under ernæringsplanen for kræftoverlevere, som kan købes og leveres til brugerens hjem fra mange forskellige dagligvarebutikker. Ernæringsnavigation giver støtte til kræftoverlevere via ugentlige check-ins for at hjælpe med at følge ernæringsretningslinjer og hjælpe med at bestille dagligvarer på Instacart-platformen. Brug af en leveringstjeneste for dagligvarer, såsom Instacart, og ernæringsnavigation kan hjælpe med at forbedre fødevareusikkerheden hos kræftoverlevere.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆR MÅL:

I. At bestemme interventionens gennemførlighed og acceptabilitet.

SEKUNDÆRE MÅL:

I. At estimere effekten af ​​interventionen på overholdelse af American Cancer Societys ernæringsretningslinjer.

II. At estimere effekten af ​​interventionen på selvrapporteret fødevareusikkerhed.

III. At evaluere gennemførligheden af ​​patientnavigationsopkald. IV. For at evaluere gennemførligheden af ​​Instacart-kuponer.

UNDERSØGENDE MÅL:

I. At evaluere gennemførligheden af ​​interventionen gennem et semistruktureret interview ved afslutningen af ​​studiet.

OVERSIGT:

Patienterne modtager et hæfte om ernæring og fysisk aktivitet for kræftoverlevere og 1 Instacart-indkøbskupon, som kan bruges i løbet af 4 uger på undersøgelsen. Patienter modtager også ernæringsnavigationstelefonopkald for at få hjælp til at følge ernæringsretningslinjer og bestille dagligvarer på Instacart en gang om ugen (QW) i 4 uger.

Efter afslutning af undersøgelsesintervention følges patienterne op efter 28 dage.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California, San Francisco
      • San Francisco, California, Forenede Stater, 94110
        • Zuckerberg San Francisco General

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Alder > 18 år
  • Diagnose af en ondartet cancer (undtagen ikke-melanom hudkræft).
  • Ikke i aktiv behandling på screeningstidspunktet og forventes ikke at modtage aktiv kræftbehandling (f.eks. kirurgi, stråling, kemoterapi, immunterapi, målrettede terapier) i løbet af undersøgelsesperioden. Hormonbehandling er tilladt for patienter med bryst- eller prostatacancer
  • Mindst 6 uger siden en større operation og fuldt restitueret.
  • Ejer en mobiltelefon og er villig og i stand til at modtage og sende sms'er.
  • Kan tale/læse engelsk.

  • Baseret på United States Department of Agriculture (USDA) United States (U.S.) Household Food Security Survey, identificer som oplever fødevareusikkerhed og/eller tilhører en befolkning, som National Institutes of Health (NIH) har identificeret som værende i fare for sundheden uligheder:

    • Identificer som en racemæssig eller etnisk minoriseret gruppe, som defineret af NIH (amerikansk indianer eller indfødt Alaska, asiatisk, sort eller afroamerikaner, indfødt hawaiiansk eller stillehavsøboer, latino eller latinamerikansk)
    • Identificer dig med en seksuel eller kønsminoriseret gruppe.
    • Årlig husstandsindkomst < 200 % af den føderale fattigdomsdefinition og/eller uddannelse < bachelorgrad.
    • Bor i et landligt og/eller et vedvarende fattigdomsområde (baseret på postnummer).

Ekskluderingskriterier:

  • Kontraindikation til enhver undersøgelsesrelateret procedure eller vurdering.
  • Planlagt større operation eller cancer-rettet terapi i løbet af undersøgelsesperioden.
  • Bor uden for USA eller Canada under screeningen og/eller studieperioden (uden for de geografiske områder, som Instacart dækker).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Supportive Care (Instacart voucher, nutrition navigation)
Participants receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Participants also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart every week for 4 weeks.
Andet: Ernæringsintervention
Modtag et hæfte om ernæring og fysisk aktivitet for kræftoverlevere
Andet: Instacart-kupon
Modtag Instacart-indkøbskuponer
Andre navne:
  • Ernæringsintervention
Adfærdsmæssigt: Telefonbaseret intervention
Modtag ernæringsnavigationstelefonopkald

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Median Score on the Feasibility of Intervention Measure (FIM) Survey
Tidsramme: At 4 week assessment, 1 day
The FIM is a four-item measure of implementation that assesses participants perceived feasibility of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher values representing a greater feasibility. The intervention will be determined feasible if the overall median score is >= 4. The median and full range of the FIM scores will be reported.
At 4 week assessment, 1 day
Median Score on the Acceptability of Intervention Measure (AIM) Survey
Tidsramme: At 4 week assessment, 1 day
The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a greater acceptability of the intervention. The intervention will be determined acceptable if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
At 4 week assessment, 1 day
Median Score on the Appropriateness of Intervention Measure (IAM) Survey
Tidsramme: At 4 week assessment, 1 day
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a higher agreement with the appropriateness of the intervention. The intervention will be determined appropriate if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
At 4 week assessment, 1 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
Tidsramme: Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
Tidsramme: Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time
Tidsramme: Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time
Tidsramme: Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time
Tidsramme: Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire
Tidsramme: Up to 4 weeks
The United States Department of Agriculture Food Insecurity Questionnaire consists of 6 items that address various aspect of food security. Responses of "often" or "sometimes" and "yes" are coded as affirmative. Responses of "almost every month" and "some months but not every month" are coded as affirmative. The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1 = High or marginal food security (raw score=1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score of 0 on the six-item scale), Raw scores of 2-4=Low food security, Raw scores 5-6=Very low food security. The mean change in raw score over time will be reported along with the standard deviation.
Up to 4 weeks
Proportion of Participants Who Participated in Navigation Calls
Tidsramme: Up to 4 weeks
The proportion of participants who participated in the weekly navigation calls by total number of calls completed will be reported.
Up to 4 weeks
Proportion of Participants Using Instacart Vouchers
Tidsramme: Up to 4 weeks
The proportion of participants who utilized the Instacart vouchers during the course of the study will be reported.
Up to 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

National Cancer Institute (NCI)
Stanford University

Efterforskere

  • Ledende efterforsker: Erin Van Blarigan, ScD, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. februar 2025

Primær færdiggørelse (Faktiske)

30. april 2025

Studieafslutning (Faktiske)

30. april 2025

Datoer for studieregistrering

Først indsendt

16. september 2024

Først indsendt, der opfyldte QC-kriterier

16. september 2024

Først opslået (Faktiske)

19. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 24806
  • NCI-2024-07163 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
  • U54CA280811 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Afidentificerede datasæt vil blive delt med forskningssamarbejdspartnere

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner