Vegetable Garden Feasibility Trial to Promote Function in Older Cancer Survivors
5 février 2016 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Réel)
46
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- University of Alabama at Birmingham
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
60 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
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receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
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|
Autre: 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.
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receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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feasibility
Délai: baseline to 12 months
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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
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baseline to 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
physical function
Délai: baseline to 12 months
|
assessed via the SF 36 physical function subscale and the senior fitness battery
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baseline to 12 months
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diet quality
Délai: baseline to 12 months
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assessed via the Diet History Questionnaire
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baseline to 12 months
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physical activity
Délai: baseline to 12 months
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assessed via the CHAMPS questionnaire with accelerometry confirmation
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baseline to 12 months
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quality of life
Délai: baseline to 12 months
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assessed via the SF-36
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baseline to 12 months
|
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biomarkers of successful aging
Délai: baseline to 12 months
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assessed via blood (serum) levels of IL-6, VCAM, d-dimer and telomerase and finger/toenail and saliva measures of cortisol
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baseline to 12 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Blair CK, Madan-Swain A, Locher JL, Desmond RA, de Los Santos J, Affuso O, Glover T, Smith K, Carley J, Lipsitz M, Sharma A, Krontiras H, Cantor A, Demark-Wahnefried W. Harvest for health gardening intervention feasibility study in cancer survivors. Acta Oncol. 2013 Aug;52(6):1110-8. doi: 10.3109/0284186X.2013.770165. Epub 2013 Feb 26.
- Cases MG, Blair CK, Hendricks PS, Smith K, Snyder S, Demark-Wahnefried W. Sustainability capacity of a vegetable gardening intervention for cancer survivors. BMC Public Health. 2022 Jun 22;22(1):1238. doi: 10.1186/s12889-022-13644-5.
- Demark-Wahnefried W, Cases MG, Cantor AB, Fruge AD, Smith KP, Locher J, Cohen HJ, Tsuruta Y, Daniel M, Kala R, De Los Santos JF. Pilot Randomized Controlled Trial of a Home Vegetable Gardening Intervention among Older Cancer Survivors Shows Feasibility, Satisfaction, and Promise in Improving Vegetable and Fruit Consumption, Reassurance of Worth, and the Trajectory of Central Adiposity. J Acad Nutr Diet. 2018 Apr;118(4):689-704. doi: 10.1016/j.jand.2017.11.001. Epub 2018 Jan 2.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2014
Achèvement primaire (Réel)
1 décembre 2015
Achèvement de l'étude (Réel)
1 décembre 2015
Dates d'inscription aux études
Première soumission
24 mai 2014
Première soumission répondant aux critères de contrôle qualité
24 mai 2014
Première publication (Estimation)
29 mai 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
9 février 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 février 2016
Dernière vérification
1 novembre 2015
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- CA182508
- R21CA182508-01 (Subvention/contrat des NIH des États-Unis)
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