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满足营养不安全的癌症幸存者的营养需求

2026年5月29日 更新者:University of California, San Francisco
该临床试验研究使用杂货配送服务 (Instacart) 和营养导航是否可以改善癌症幸存者的粮食不安全状况。 美国癌症协会建议癌症患者保持正常的体重指数、定期的身体活动和健康的饮食。 遵循这些指南可能有助于预防癌症患者死亡,但很少有癌症患者遵循这些指南。 不遵守准则的原因之一可能是由于无法持续获得足够数量的负担得起的营养食品以实现积极、健康的生活(粮食不安全)。 Instacart 为用户提供了属于癌症幸存者营养计划范围内的食物,这些食物可以从许多不同的杂货店购买并运送到用户家中。 营养导航通过每周检查为癌症幸存者提供支持,帮助他们遵循营养指南并协助在 Instacart 平台上订购杂货。 使用 Instacart 等杂货配送服务和营养导航可能有助于改善癌症幸存者的粮食不安全状况。

研究概览

详细说明

主要目标:

I. 确定干预措施的可行性和可接受性。

次要目标:

I. 评估干预措施对遵守美国癌症协会营养指南的影响。

二. 评估干预措施对自我报告的粮食不安全的影响。

三. 评估患者导航呼叫的可行性。 四. 评估 Instacart 优惠券的可行性。

探索性目标:

I. 通过研究结束半结构化访谈评估干预的可行性。

大纲:

患者会收到一本关于癌症幸存者营养和身体活动的小册子和一张 Instacart 杂货配送券,可在 4 周的研究中使用。 患者还会接到营养导航电话,寻求帮助,以遵循营养指南,并每周 (QW) 一次在 Instacart 上订购杂货,持续 4 周。

研究干预完成后,患者将在 28 天后接受随访。

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Francisco、California、美国、94143
        • University of California, San Francisco
      • San Francisco、California、美国、94110
        • Zuckerberg San Francisco General

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准:

  • 年龄 > 18 岁
  • 恶性癌症的诊断(非黑色素瘤皮肤癌除外)。
  • 筛选时未接受积极治疗,并且预计在研究期间不会接受积极抗癌治疗(例如手术、放射、化疗、免疫治疗、靶向治疗)。 乳腺癌或前列腺癌患者可以接受激素疗法
  • 距离大手术并完全康复至少 6 周。
  • 拥有手机,愿意并且能够接收和发送短信。
  • 能够说/读英语。
  • 根据美国农业部 (USDA) 美国家庭粮食安全调查,确定正在经历粮食不安全和/或属于美国国立卫生研究院 (NIH) 确定存在健康风险的人群差异:

    • 被认定为 NIH 定义的种族或族裔少数群体(美洲印第安人或阿拉斯加原住民、亚洲人、黑人或非裔美国人、夏威夷原住民或太平洋岛民、拉丁裔或西班牙裔)
    • 认同性或性别少数群体。
    • 家庭年收入 < 联邦贫困定义的 200% 和/或教育程度 < 学士学位。
    • 居住在农村和/或持续贫困地区(根据邮政编码)。

排除标准:

  • 任何与研究相关的程序或评估的禁忌症。
  • 研究期间计划进行的大手术或癌症定向治疗。
  • 在筛选和/或研究期间居住在美国或加拿大境外(Instacart 覆盖的地理区域之外)。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Supportive Care (Instacart voucher, nutrition navigation)
Participants receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Participants also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart every week for 4 weeks.
收到一本关于癌症幸存者的营养和身体活动的小册子
接收 Instacart 杂货配送券
其他名称:
  • 营养干预
接听营养导航电话

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Median Score on the Feasibility of Intervention Measure (FIM) Survey
大体时间:At 4 week assessment, 1 day
The FIM is a four-item measure of implementation that assesses participants perceived feasibility of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher values representing a greater feasibility. The intervention will be determined feasible if the overall median score is >= 4. The median and full range of the FIM scores will be reported.
At 4 week assessment, 1 day
Median Score on the Acceptability of Intervention Measure (AIM) Survey
大体时间:At 4 week assessment, 1 day
The AIM is a four-item measure of implementation that assesses participants perceived acceptability of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a greater acceptability of the intervention. The intervention will be determined acceptable if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
At 4 week assessment, 1 day
Median Score on the Appropriateness of Intervention Measure (IAM) Survey
大体时间:At 4 week assessment, 1 day
The IAM is a four-item measure of implementation that assesses participants perceived appropriateness of the intervention. Each item response falls on a scale of 1 (Completely disagree) to 5 (Completely agree). A total score is calculated by averaging responses. Total score values range from 1 to 5 with higher scores indicating a higher agreement with the appropriateness of the intervention. The intervention will be determined appropriate if the overall median score is >= 4. The median and full range of the AIM scores will be reported.
At 4 week assessment, 1 day

次要结果测量

结果测量
措施说明
大体时间
Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
大体时间:Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time
大体时间:Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time
大体时间:Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time
大体时间:Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range of scores will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time
大体时间:Up to 4 weeks
The DSQ is a 19-item questionnaire which assesses intakes of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium assessment of nutritional intake from the National Health and Nutrition Examination Survey (NHANES) to assess dietary habits. This brief screener asks participants to report on dietary intake in the past month. Dietary factors assessed include fruit and vegetables, fiber, whole grains, added sugars, red meat, and processed meat. The scoring algorithms that convert DSQ data to nutrient and food-group estimates and appropriate analysis programs are available from the NCI (https://epi.grants.cancer.gov/nhanes/dietscreen/scoring/). A theoretical maximum and/or minimum value for the overall intake scores on the DSQ does not exist. Change in median overall intake values on the DSQ to assess adherence to the American Cancer Society nutrition guidelines and full range will be used to describe the change of overall adherence over time.
Up to 4 weeks
Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire
大体时间:Up to 4 weeks
The United States Department of Agriculture Food Insecurity Questionnaire consists of 6 items that address various aspect of food security. Responses of "often" or "sometimes" and "yes" are coded as affirmative. Responses of "almost every month" and "some months but not every month" are coded as affirmative. The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1 = High or marginal food security (raw score=1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score of 0 on the six-item scale), Raw scores of 2-4=Low food security, Raw scores 5-6=Very low food security. The mean change in raw score over time will be reported along with the standard deviation.
Up to 4 weeks
Proportion of Participants Who Participated in Navigation Calls
大体时间:Up to 4 weeks
The proportion of participants who participated in the weekly navigation calls by total number of calls completed will be reported.
Up to 4 weeks
Proportion of Participants Using Instacart Vouchers
大体时间:Up to 4 weeks
The proportion of participants who utilized the Instacart vouchers during the course of the study will be reported.
Up to 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Erin Van Blarigan, ScD、University of California, San Francisco

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月4日

初级完成 (实际的)

2025年4月30日

研究完成 (实际的)

2025年4月30日

研究注册日期

首次提交

2024年9月16日

首先提交符合 QC 标准的

2024年9月16日

首次发布 (实际的)

2024年9月19日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 24806
  • NCI-2024-07163 (注册表标识符:NCI Clinical Trials Reporting Program (CTRP))
  • U54CA280811 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

去识别化的数据集将与研究合作者共享

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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