Food Insecurity in Oncology (FIOnc)

New Mexico Cancer Care Alliance

Status: Completed

Conditions: Food Insecurity; Cancer

Treatments: Behavioral: Unconditional Cash Transfer (UCT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05176743

5UG1CA189824-07 (U.S. NIH Grant/Contract)

INST UNM 2104

Details and patient eligibility

About

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.

Full description

In this delayed intervention trial, 44 female breast and gynecologic cancer patients experiencing food insecurity will be randomized in a 1:1 ratio to receive unconditional cash transfers (UCT) for 3 months or an equivalent one-time UCT at the end of the study.

Quantitative surveys will be administered at baseline and after 3-months. Survey measures will include questions about health care resource utilization, health-related quality of life, food security, hospitalization use, emergency department use, and mental health. The main objective for this pilot trial is to assess feasibility. The investigators will measure whether the investigators can: recruit 44 food insecure participants meeting the eligibility criteria over a 3-month recruitment window and describe the barriers and facilitators of the recruitment process. The investigators will also monitor retention and survey completion. At the end of the 3 month follow-up period, all participants will complete a semi-structured exit interview.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Usual Care

Other group

Description:

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

Treatment:

Behavioral: Unconditional Cash Transfer (UCT)

Unconditional Cash Transfer Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Unconditional Cash Transfer (UCT)