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Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors

5 februari 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Faktisk)

46

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294
        • University of Alabama at Birmingham

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Beteende: Experimental: Mentored Gardening Intervention
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
Övrig: 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.
Beteende: Experimental: Mentored Gardening Intervention
receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
feasibility
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
physical function
Tidsram: baseline to 12 months
assessed via the SF 36 physical function subscale and the senior fitness battery
baseline to 12 months
diet quality
Tidsram: baseline to 12 months
assessed via the Diet History Questionnaire
baseline to 12 months
physical activity
Tidsram: baseline to 12 months
assessed via the CHAMPS questionnaire with accelerometry confirmation
baseline to 12 months
quality of life
Tidsram: baseline to 12 months
assessed via the SF-36
baseline to 12 months
biomarkers of successful aging
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Alabama at Birmingham

Samarbetspartners

National Cancer Institute (NCI)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2014

Primärt slutförande (Faktisk)

1 december 2015

Avslutad studie (Faktisk)

1 december 2015

Studieregistreringsdatum

Först inskickad

24 maj 2014

Först inskickad som uppfyllde QC-kriterierna

24 maj 2014

Första postat (Uppskatta)

29 maj 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

9 februari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 februari 2016

Senast verifierad

1 november 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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