Food Insecurity in Oncology

NCT ID: NCT05176743

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-30

Study Completion Date

2022-06-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Food Insecurity Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

No blinding will be used in this pilot trial.

Study Groups

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Usual Care

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

Group Type OTHER

Unconditional Cash Transfer (UCT)

Intervention Type 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

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

Group Type EXPERIMENTAL

Unconditional Cash Transfer (UCT)

Intervention Type 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.

Interventions

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Unconditional Cash Transfer (UCT)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico Cancer Center

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

New Mexico Cancer Research Alliance

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean A McDougall, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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5UG1CA189824-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

INST UNM 2104

Identifier Type: -

Identifier Source: org_study_id

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