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Trial Title:
Addressing the Nutritional Needs of Cancer Survivors With Nutrition Insecurity
NCT ID:
NCT06602999
Condition:
Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Nutrition
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Nutritional Intervention
Description:
Receive a booklet on nutrition and physical activity for cancer survivors
Arm group label:
Supportive Care (Instacart voucher, nutrition navigation)
Intervention type:
Other
Intervention name:
Instacart Voucher
Description:
Receive Instacart grocery delivery voucher
Arm group label:
Supportive Care (Instacart voucher, nutrition navigation)
Other name:
Nutritional Intervention
Intervention type:
Behavioral
Intervention name:
Telephone-Based Intervention
Description:
Receive nutrition navigation phone calls
Arm group label:
Supportive Care (Instacart voucher, nutrition navigation)
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.
Criteria for 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.
- Owns a mobile phone and is willing and able to receive and send 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zuckerberg San Francisco General
Address:
City:
San Francisco
Zip:
94110
Country:
United States
Contact:
Last name:
Paul Couey
Phone:
415-514-8889
Email:
paul.couey@ucsf.edu
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Contact:
Last name:
Paige Steiding
Phone:
415-502-3310
Email:
paige.steiding@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Sorbarikor Piawah, MD
Email:
Principal Investigator
Investigator:
Last name:
Erin Van Blarigan, ScD
Email:
Sub-Investigator
Start date:
January 2, 2025
Completion date:
May 31, 2027
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Stanford University
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06602999
