Clinical trial NCT06602999: Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity
Official title: Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Keywords: Nutrition
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Stanford University
First posted: 2024-09-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

III. To evaluate the feasibility of patient navigation calls. IV. To evaluate the feasibility of Instacart vouchers.

EXPLORATORY OBJECTIVE:

I. To evaluate the feasibility of the intervention through an end-of-study semi-structured interview.

OUTLINE:

Patients receive a booklet on nutrition and physical activity for cancer survivors and 1 Instacart grocery delivery voucher to use over 4 weeks on study. Patients also receive nutrition navigation phone calls for assistance with following nutrition guidelines and ordering groceries on Instacart once a week (QW) for 4 weeks.

After completion of study intervention, patients are followed up at 28 days.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Median score on the Feasibility of Intervention Measure (FIM) score
timeFrame: 4 weeks
measure: Median score on the Acceptability of Intervention Measure (AIM) score
timeFrame: 4 weeks
measure: Appropriateness of intervention measure (IAM) score
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in intake of fruit and vegetables, whole grains, sugar sweetened beverages, red meat, and processed meat
timeFrame: Up to 4 weeks
measure: Mean change in participant reported United States Department of Agriculture Food Insecurity score
timeFrame: Up to 4 weeks
measure: Proportion of participants who completed navigation calls
timeFrame: Up to 4 weeks
measure: Proportion of participants using Instacart vouchers
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sorbarikor Piawah, MD
role: PRINCIPAL_INVESTIGATOR
References: