Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity

NCT06602999 | Completed

• 3 other identifiers: 24806NCI-2024-07163U54CA280811
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Keywords

Nutrition

Outcome Measures

Primary Outcomes (3)

• Median score on the Feasibility of Intervention Measure (FIM) score

  The FIM 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 scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4. The median and (interquartile range (IQR) of the FIM score.

  4 weeks

• Median score on the Acceptability of Intervention Measure (AIM) score

  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 scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4. The median and (IQR) of the AIM score.

  4 weeks

• Appropriateness of intervention measure (IAM) score

  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 scaled score is calculated by averaging responses. Scale values range from 1 to 5. The intervention will be determined acceptable if the overall median score is \>= 4. The median and (IQR) of the AIM score.

  4 weeks

Secondary Outcomes (4)

• Change in intake of fruit and vegetables, whole grains, sugar sweetened beverages, red meat, and processed meat

  Up to 4 weeks

• Mean change in participant reported United States Department of Agriculture Food Insecurity score

  Up to 4 weeks

• Proportion of participants who completed navigation calls

  Up to 4 weeks

• Proportion of participants using Instacart vouchers

  Up to 4 weeks

Study Arms (1)

Supportive Care (Instacart voucher, nutrition navigation)

EXPERIMENTAL

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

Other: Nutritional Intervention; Other: Instacart Voucher; Behavioral: Telephone-Based Intervention

Interventions

Nutritional Intervention OTHER

Receive a booklet on nutrition and physical activity for cancer survivors

Supportive Care (Instacart voucher, nutrition navigation)

Instacart Voucher OTHER

Receive Instacart grocery delivery voucher

Also known as: Nutritional Intervention

Supportive Care (Instacart voucher, nutrition navigation)

Telephone-Based Intervention BEHAVIORAL

Receive nutrition navigation phone calls

Supportive Care (Instacart voucher, nutrition navigation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator
• Stanford University: collaborator

Study Sites (2)

Zuckerberg San Francisco General

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Study Officials

• Sorbarikor Piawah, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: February 4, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (2)