Food Insecurity in Oncology (FIOnc)

Food Insecurity in Oncology (FIOnc)

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Food Insecurity
• Intervention / Treatment: Behavioral: Unconditional Cash Transfer (UCT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care; Referral to services; Nutrition pamphlets; One-time payment of $300 paid 4 months after baseline	Behavioral: 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.
Experimental: Unconditional Cash Transfer Intervention; Three monthly payments of $100; Referral to services; Nutrition pamphlets	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Nine of the Global Health PROMIS measures items are scored on a Likert scale, with 1 representing the worst health situation and 5 representing the best health situation. Pain is scored from 0 to 10 with 0 indicating no pain and 10 representing the worst pain ever experienced. Two sub-scores can also be derived from the 10 item questionnaire to assess physical and mental health separately. Raw scores must be converted to a standardized T-score for interpretation. A higher PROMIS T-score indicates a person whose health is better than the average respondent.	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
Determine the number of patients who report being hospitalized during the 3 month follow-up period as well as the number of times they are hospitalized		3 months
Assess number of participants experiencing depression using the Patient Health Questionnaire (PHQ-9) screener tool		3 months
Assess participants perceived self-efficacy using the PROMIS Self-Efficacy for Managing Medications and Treatments 4a questionnaire	The 4 questions that comprise this measure are measured on a Likert scale with 1 representing that the respondent is "not at all confident" completing the described task and 5 representing that the respondent is "very confident" completing the task. Raw scores range from 4-20, but T-score conversions are needed for interpretation. A higher PROMIS T-score indicates a person whose health is better than the average respondent.	3 months
Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)		3 months

Collaborators and Investigators

• Sponsor: New Mexico Cancer Care Alliance
• Collaborators: National Cancer Institute (NCI); Wake Forest University Health Sciences; University of New Mexico Cancer Center
• Investigators: Principal Investigator: Jean A McDougall, PhD, MPH, University of New Mexico, Internal Medicine/Epidemiology, Biostatistics & Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: INST UNM 2104; 5UG1CA189824-07 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No