Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Median Score on the Feasibility of Intervention Measure (FIM) Survey
研究概览
简要总结
This clinical trial studies whether the use of a grocery delivery service (Instacart) and nutrition navigation improves food insecurity in cancer survivors. The American Cancer Society recommends a normal body mass index, regular physical activity, and a healthy diet for cancer patients. Following these guidelines may help prevent deaths among cancer patients, but few cancer patients follow them. One reason for not following the guidelines could be due to the lack of consistent access to sufficient quantities of affordable, nutritious food for an active, healthy life (food insecurity). Instacart provides users access to foods that fall under the nutrition plan for cancer survivors that can be purchased and delivered to the user's home from many different grocery stores. Nutrition navigation provides support to cancer survivors via weekly check ins to help with following nutrition guidelines and assist with ordering groceries on the Instacart platform. Using a grocery delivery service, such as Instacart, and nutrition navigation may help improve food insecurity in cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To determine the intervention's feasibility and acceptability.
SECONDARY OBJECTIVES:
I. To estimate the effect of the intervention on adherence to American Cancer society nutrition guidelines.
II. To estimate the effect of the intervention on self-reported food insecurity.
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
- 否
入选标准
- •Age > 18 years
- •Diagnosis of a malignant cancer (except non-melanoma skin cancer).
- •Not on active treatment at the time of screening and not expected to receive active anticancer therapy (e.g., surgery, radiation, chemotherapy, immunotherapy, targeted therapies) during the study period. Hormonal therapies are allowed for patients with breast or prostate cancer
- •At least 6 weeks since a major surgery and fully recovered.
- •Have access to the internet and able to send and receive text messages.
- •Able to speak/read English.
- •Based on the United States Department of Agriculture (USDA) United States (U.S.) Household Food Security Survey, identify as experiencing food insecurity and/or belong to a population that the National Institutes of Health (NIH) has identified as being at risk for health disparities:
- •Identify as a racial or ethnic minoritized group, as defined by the NIH (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, Latino or Hispanic)
- •Identify with a sexual or gender minoritized group.
- •Annual household income < 200% of the federal poverty definition and/or education < bachelor's degree.
- •Live in a rural and/or a persistent poverty area (based on zip code).
排除标准
- •Contraindication to any study-related procedure or assessment.
- •Planned major surgery or cancer-directed therapy during the study period.
- •Living outside of the US or Canada during screening and/or the study period (outside the geographic areas that Instacart covers).
研究组 & 干预措施
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.
干预措施: Nutritional Intervention (Other)
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.
干预措施: Instacart Voucher (Other)
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.
干预措施: Telephone-Based Intervention (Behavioral)
结局指标
主要结局
Median Score on the Feasibility of Intervention Measure (FIM) Survey
时间窗: 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.
Median Score on the Acceptability of Intervention Measure (AIM) Survey
时间窗: 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.
Median Score on the Appropriateness of Intervention Measure (IAM) Survey
时间窗: 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.
次要结局
- Change in Median Score on the Red Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time(Up to 4 weeks)
- Change in Median Score on the Processed Meat Category of the Dietary Screener Questionnaire (DSQ) Over Time(Up to 4 weeks)
- Change in Median Score on the Whole Grains Category of the Dietary Screener Questionnaire (DSQ) Over Time(Up to 4 weeks)
- Change in Median Score on the Sugar-Sweetened Beverages Category of the Dietary Screener Questionnaire (DSQ) Over Time(Up to 4 weeks)
- Change in Median Score on the Frut and Vegetable Category of the Dietary Screener Questionnaire (DSQ) Over Time(Up to 4 weeks)
- Change in Mean Score on Participant Reported United States Department of Agriculture Food Insecurity Questionnaire(Up to 4 weeks)
- Proportion of Participants Who Participated in Navigation Calls(Up to 4 weeks)
- Proportion of Participants Using Instacart Vouchers(Up to 4 weeks)