Food Insecurity in Oncology

NCT05176743 | Completed DMC

• 2 other identifiers: INST UNM 21045UG1CA189824-07
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will examine the feasibility and preliminary effectiveness of providing unconditional cash transfers to food insecure female breast and gynecologic cancer patients. Approximately one-third of cancer survivors report food insecurity, characterized by limited access to adequate food for active, healthy living because of a lack of money and other resources. Unconditional cash transfers offer direct monetary assistance that can be used to meet immediate food or other financial needs and may positively impact health care resource utilization and health-related quality of life.

Conditions

Food Insecurity; Cancer

Outcome Measures

Primary Outcomes (3)

• Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so

  3 months

• Determine the percentage of patients who complete both the baseline and 3 month follow-up survey

  3 months

• Determine the number of participants who complete the surveys

  3 months

Secondary Outcomes (9)

• Assess healthcare resource utilization using the PhenX-Access to Health Services toolkit

  3 months

• Healthcare costs

  3 months

• Assess health-related quality of life using the PROMIS Global Health 10 item questionnaire

  3 months

• Assess the number of participants who are food insecure using the Hunger VitalSign food insecurity screening tool

  3 months

• Determine the number of patients who use the Emergency Department during the 3 month follow-up period as well as how many visits they have

  3 months

Study Arms (2)

Usual Care

OTHER

* Referral to services * Nutrition pamphlets * One-time payment of $300 paid 4 months after baseline

Behavioral: Unconditional Cash Transfer (UCT)

Unconditional Cash Transfer Intervention

EXPERIMENTAL

* Three monthly payments of $100 * Referral to services * Nutrition pamphlets

Behavioral: Unconditional Cash Transfer (UCT)

Interventions

Unconditional Cash Transfer (UCT) BEHAVIORAL

The UCT consists of three $100 VISA merchandise cards provided monthly via mail to participants randomized to the intervention arm. Merchandise cards can be used anywhere that VISA is accepted. Participants in the UCT arm will also receive Usual Care, including referral to the patient support services team and nutritional pamphlets.

Unconditional Cash Transfer Intervention; Usual Care

Eligibility Criteria

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

You may qualify if:

• Diagnosis of female breast (ICD-10 C50), ovarian (ICD-10 C56), endometrial (ICD-10 C54), cervical (ICD-10 C53), vulvar cancer (ICD-10 C51)
• Diagnosed within 24-months of identification
• Stage I-III
• Completed initial course of cancer directed therapy (surgery, radiation, chemotherapy).
• Age ≥18
• Able to speak English or Spanish
• Food insecure

You may not qualify if:

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners

Sponsors & Collaborators

• New Mexico Cancer Research Alliance: lead
• University of New Mexico Cancer Center: collaborator
• Wake Forest University Health Sciences: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jean A McDougall, PhD, MPH

  University of New Mexico, Internal Medicine/Epidemiology, Biostatistics & Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No blinding will be used in this pilot trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized pilot trial. Eligible individuals will be identified from breast and gynecologic clinics in the New Mexico Cancer Care Alliance. Participants will be screened for food insecurity and asked to complete a baseline survey. Participants will then be randomized to either Usual Care or to the UCT intervention. All participants will complete a 3-month follow-up, survey and a qualitative exit interview.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: January 4, 2022
• Study Start: August 30, 2021
• Primary Completion: March 2, 2022
• Study Completion: June 20, 2022
• Last Updated: October 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)