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Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors

5. februar 2016 opdateret af: University of Alabama at Birmingham
Cancer survivorship has been claimed a national priority, with a call to develop effective interventions that can prevent, delay, or mitigate the adverse effects and comorbidities in this high risk population. Strong evidence exists that a healthful diet and regular physical activity can prevent many chronic diseases and improve physical function. More research however is needed to develop interventions that can produce long-term adherence to healthful lifestyle behaviors. This pilot study is based on the hypothesis that vegetable gardening interventions will be feasible and result in improvements in diet and exercise behaviors as well as improvements in physical functioning and well-being.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The proposed feasibility study relies on the extant infra-structure of the Alabama Cooperative Extension Master Gardener Program. A total of 46 older (≥65 years) cancer survivors recently diagnosed with a loco-regionally staged cancer with a good prognosis (i.e., ≥ 80% 5-year survival) and with 2 or more physical function limitations will be recruited from select rural and urban counties in Alabama and randomized to 1-of-2 study arms: 1) an intervention group that receives a 1-year mentored vegetable gardening intervention that pairs cancer survivors with certified Master Gardeners, or 2) a usual care control group that is observed during the year, but receives the gardening supplies at study completion. Aims of this study are to: 1) explore the feasibility and acceptability of a mentored vegetable gardening intervention by assessing accrual, retention, adherence, fidelity, and possible adverse events, 2) obtain means and precision estimates, and explore between-arm differences on pre-post changes in physical function and secondary endpoints (e.g., quality of life, fruit & vegetable intake, physical activity, etc.), and 3) to explore participant factors associated with program efficacy (e.g., gender, comorbidity).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

46

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
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham

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

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • diagnosed with a loco-regionally staged cancer associated with an 60% or greater 5-year survival rate (localized and regional staged breast, Hodgkin lymphoma, prostate, ovary, endometrial, colorectal and thyroid cancers; localized cervix, kidney/renal pelvis, non-Hodgkin lymphoma, oral cavity/pharynx, small intestine, bladder and soft tissue cancers; and in situ bladder & breast cancer); and distant Hodgkin Lymphoma, and Testicular cancers.
  • resides in select counties in Alabama;
  • completed primary curative cancer treatments, i.e., surgery, chemotherapy or radiation therapy;
  • at higher risk of functional decline (≥ 1 physical function (PF) limitations as defined by the SF36 PF subscale);
  • currently eats less than 5 servings of fruits and vegetables/day;
  • exercises less than 150 minutes/ week;
  • speaks, reads and writes in English
  • reside in a location that can accommodate 4 or more Earthboxes or 1-raised bed (4'x 8'), and that get at least 4 hours of sun a day with running water;
  • willing to be randomized to either study arm and participate in the follow-up.

Exclusion Criteria

  • history of lymphedema flares and axillary node dissection of 10 or more lymph nodes on one side of the body;
  • not competent due to mental health or other very serious comorbid conditions (e.g., severe orthopedic conditions or scheduled for a hip or knee replacement with 6 months, paralysis, unstable angina or who have experienced a myocardial infarction, congestive heart failure or pulmonary conditions that require hospitalization or oxygen within 6 months, stroke, degenerative neurological conditions);
  • currently taking pharmacologic doses of warfarin (does not include doses taken to maintain a port); or
  • plants a vegetable garden at least annually

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mentored Gardening Intervention
Participants in this arm will be provided with either a raised bed garden or 4 earthboxes, gardening supplies, and plants and seeds. A master gardener from the Cooperative Extension will mentor them over the course of a year to plant three gardens (spring, summer and fall).
Adfærdsmæssigt: Experimental: Mentored Gardening Intervention
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
Andet: Wait-List
Participants in this arm will be provided with the same gardening supplies as the other group, but will receive them one year after enrollment in the study. They also will receive instruction from a master gardener from the Cooperative Extension at this time as well.
Adfærdsmæssigt: Experimental: Mentored Gardening Intervention
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
feasibility
Tidsramme: baseline to 12 months
attainment of accrual target of 46 eligible enrolled participants, retention of at least 80% of participants over the 12-month study period and the absence of any serious events attributable to the intervention
baseline to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
physical function
Tidsramme: baseline to 12 months
assessed via the SF 36 physical function subscale and the senior fitness battery
baseline to 12 months
diet quality
Tidsramme: baseline to 12 months
assessed via the Diet History Questionnaire
baseline to 12 months
physical activity
Tidsramme: baseline to 12 months
assessed via the CHAMPS questionnaire with accelerometry confirmation
baseline to 12 months
quality of life
Tidsramme: baseline to 12 months
assessed via the SF-36
baseline to 12 months
biomarkers of successful aging
Tidsramme: baseline to 12 months
assessed via blood (serum) levels of IL-6, VCAM, d-dimer and telomerase and finger/toenail and saliva measures of cortisol
baseline to 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Alabama at Birmingham

Samarbejdspartnere

National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. april 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

24. maj 2014

Først indsendt, der opfyldte QC-kriterier

24. maj 2014

Først opslået (Skøn)

29. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2016

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CA182508
  • R21CA182508-01 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Experimental: Mentored Gardening Intervention

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