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临床试验/NCT07565896
NCT07565896尚未招募不适用

Gardening for Health for Cancer Survivors (G4H-CS)

University of Vermont Medical Center0 个研究点目标入组 15 人开始时间: 2028年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
主要终点
Acceptability of the Gardening and Nutrition Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Currently significantly immunosuppressed

研究组 & 干预措施

Gardening and Nutrition Intervention for Cancer Survivors

Experimental

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.

干预措施: Gardening and Nutrition Intervention (Behavioral)

结局指标

主要结局

Acceptability of the Gardening and Nutrition Intervention

时间窗: At 6 weeks (post-intervention)

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).

Recruitment Rate

时间窗: At 6 weeks (post-intervention)

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)

Retention Rate

时间窗: At 6 weeks (post-intervention)

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 (%)

Session Attendance

时间窗: During the 6-week intervention period

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 (%)

Assessment Completion Rate

时间窗: At 6 weeks (post-intervention)

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 (%)

次要结局

  • Change in Health-Related Quality of Life (SF-36)(Baseline to 6 weeks)
  • Change in Perceived Stress (Perceived Stress Scale)(Baseline to 6 weeks)
  • Change in Sense of Belonging (General Belongingness Scale)(Baseline to 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Randall F Holcombe

Director-Faculty

University of Vermont Medical Center

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