- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07565896
Gardening for Health for Cancer Survivors (G4H-CS)
Gardening for Health for Cancer Survivors (G4H-CS)
This study is testing whether a gardening and nutrition program can improve well-being in people who have had cancer. Many cancer survivors continue to experience challenges after treatment, including changes in appetite, nutrition, stress, and quality of life. Programs that combine healthy eating, physical activity, and social connection may help address these issues.
In this study, participants will take part in a 6-week, in-person program called Gardening for Health. The program includes weekly group sessions held at a garden at the University of Vermont Medical Center. Each session lasts about two hours and includes hands-on gardening activities, nutrition education, cooking demonstrations, and guided wellness practices such as mindfulness and light movement. Participants will also receive educational materials to support healthy eating and gardening at home.
The main goal of the study is to determine whether this program is feasible and acceptable for cancer survivors, meaning whether people are willing to participate, attend sessions, and find the program helpful and satisfying. The study will also explore whether participation is associated with improvements in quality of life, stress, sense of belonging, and nutrition-related behaviours.
Participants will complete questionnaires before starting the program and again after the 6-week program ends. These surveys will ask about overall health, stress levels, social connection, and lifestyle habits.
The researchers hypothesize that participation in the Gardening for Health program will be feasible and well-received by cancer survivors, and that it may lead to improvements in quality of life, reduced stress, and increased feelings of connection and well-being.
This is a single-group study, all participants receive the intervention and there is no comparison group. The results will help determine whether this type of program should be studied further in larger trials.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, single-center, single-arm feasibility study designed to evaluate a structured gardening and nutrition-based intervention, among adult cancer survivors. The study will enroll approximately 15 participants at the University of Vermont Cancer Center.
Cancer survivors frequently experience persistent challenges following treatment, including nutritional deficits, altered taste and appetite, reduced physical activity, psychosocial stress, and decreased quality of life. Prior research has demonstrated that multi-component lifestyle interventions, may improve dietary intake, physical functioning, and psychosocial outcomes. Building on this evidence and prior pilot work conducted at the University of Vermont Medical Center, this study evaluates an adapted, short-duration gardening and nutrition intervention tailored specifically for cancer survivors.
The intervention consists of six weekly, in-person sessions delivered over approximately six weeks in a rooftop garden setting. Each session is approximately two hours in duration and is led by a multidisciplinary team. The intervention integrates hands-on gardening activities, nutrition education, culinary instruction, and experiential components such as mindfulness, light physical activity, and nature-based engagement.
The primary objective is to evaluate feasibility and acceptability of the intervention, assessed through recruitment, retention, attendance, and participant satisfaction. Secondary objectives include assessing pre- to post-intervention changes in psychosocial outcomes, including health-related quality of life, perceived stress, and sense of belonging, as well as exploratory changes in nutrition-related knowledge and behaviors.
Participants will complete self-report assessments at baseline (prior to intervention initiation) and immediately following completion of the intervention. Qualitative feedback collected through post-intervention surveys will be analyzed to characterize participant experience and perceived impact.
This study is not powered to detect statistically significant differences in outcomes but is intended to generate preliminary data on feasibility, acceptability, and potential signals of efficacy to inform the design of future controlled trials.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Randall F Holcombe, MD
- Número de teléfono: 1 (802) 656-2021
- Correo electrónico: Randall.holcombe@med.uvm.edu
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Self-reported current or prior diagnosis of cancer
- Self-identifies as a cancer survivor
- Ability to read, write, and speak English
Exclusion Criteria:
- Currently significantly immunosuppressed
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Gardening and Nutrition Intervention for Cancer Survivors
Participants will receive a six-week, in-person gardening and nutrition-based intervention delivered at the University of Vermont Medical Center rooftop garden.
The program consists of six weekly sessions, each approximately two hours in duration, led by a multidisciplinary team.
Participants will also receive educational materials to support gardening and healthy eating.
Outcomes will be assessed using self-report questionnaires administered at baseline prior to the intervention and immediately following completion of the program.
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The intervention is a structured, six-week, in-person gardening and nutrition-based program delivered at the University of Vermont Medical Center rooftop garden. Participants will attend one session per week, each approximately two hours in duration, for a total of six sessions. The program is led by a multidisciplinary team. Each session integrates hands-on gardening activities (e.g., planting, garden maintenance, harvesting), nutrition education (e.g., dietary fiber, hydration, anti-inflammatory foods), and culinary instruction focused on preparing healthy meals. The program also incorporates experiential components such as mindfulness practices, light physical activity, and engagement with natural outdoor environments. Participants will receive educational materials, including a gardening and nutrition curriculum packet, to support continued application of skills outside of the sessions. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability of the Gardening and Nutrition Intervention
Periodo de tiempo: At 6 weeks (post-intervention)
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Acceptability will be assessed using a post-intervention participant satisfaction survey. Measures will include participant-reported satisfaction with the program, perceived usefulness of the intervention components, and willingness to recommend the program to others. Responses will be summarized descriptively to evaluate overall participant satisfaction and perceived value of the intervention. Responses will be scored on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). |
At 6 weeks (post-intervention)
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Recruitment Rate
Periodo de tiempo: At 6 weeks (post-intervention)
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Recruitment rate will be defined as the number of participants enrolled divided by the number of eligible participants who expressed interest in the study during the recruitment period. Unit of Measure: Percentage (%) Time Frame: During study enrollment period (up to 6 weeks) |
At 6 weeks (post-intervention)
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Retention Rate
Periodo de tiempo: At 6 weeks (post-intervention)
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Retention rate will be defined as the proportion of enrolled participants who complete the full intervention and post-intervention assessments (T2). Unit of Measure: Percentage (%) |
At 6 weeks (post-intervention)
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Session Attendance
Periodo de tiempo: During the 6-week intervention period
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Session attendance will be defined as the number of intervention sessions attended by each participant out of 6 total sessions. Attendance will be summarized as both the mean number of sessions attended and the proportion of sessions attended. Unit of Measure: Number of sessions (0-6) and Percentage (%) |
During the 6-week intervention period
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Assessment Completion Rate
Periodo de tiempo: At 6 weeks (post-intervention)
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Assessment completion will be defined as the proportion of participants who complete all required baseline (T1) and post-intervention (T2) questionnaires. Unit of Measure: Percentage (%) |
At 6 weeks (post-intervention)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Health-Related Quality of Life (SF-36)
Periodo de tiempo: Baseline to 6 weeks
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Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 evaluates eight domains, including physical functioning, role limitations, emotional well-being, social functioning, pain, energy, and general health. Scores will be calculated according to standard scoring procedures, and changes from baseline to post-intervention will be analyzed. Each domain score is transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life. The outcome will be defined as the change in SF-36 domain scores from baseline (T1) to post-intervention (T2). |
Baseline to 6 weeks
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Change in Perceived Stress (Perceived Stress Scale)
Periodo de tiempo: Baseline to 6 weeks
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Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS). The PSS measures the degree to which situations in one's life are perceived as stressful over the past month. The PSS includes 10 items rated on a Likert scale from 0 (never) to 4 (very often), with total scores ranging from 0 to 40. Total scores will be calculated, and changes from baseline to post-intervention will be evaluated. Higher scores indicate greater perceived stress (worse outcome). The outcome will be defined as the change in total PSS score from baseline (T1) to post-intervention (T2). |
Baseline to 6 weeks
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Change in Sense of Belonging (General Belongingness Scale)
Periodo de tiempo: Baseline to 6 weeks
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Sense of belonging will be assessed using the General Belongingness Scale (GBS), which measures feelings of social inclusion and rejection. The GBS consists of 12 items rated on a Likert scale from 1 (strongly disagree) to 7 (strongly agree), with total scores ranging from 12 to 84. Total and subscale scores will be calculated, and changes from baseline to post-intervention will be analyzed. Higher scores indicate greater sense of belonging (better outcome). |
Baseline to 6 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00004151/UVMCC2602
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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