Clinical trial NCT05176743: Food Insecurity in Oncology
Official title: Food Insecurity in Oncology (FIOnc)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Cancer
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: University of New Mexico Cancer Center
name: Wake Forest University Health Sciences
name: National Cancer Institute (NCI)
First posted: 2022-01-04
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so
timeFrame: 3 months
measure: Determine the percentage of patients who complete both the baseline and 3 month follow-up survey
timeFrame: 3 months
measure: Determine the number of participants who complete the surveys
timeFrame: 3 months
Secondary outcomes:
measure: Assess healthcare resource utilization using the PhenX-Access to Health Services toolkit
timeFrame: 3 months
measure: Healthcare costs
timeFrame: 3 months
measure: Assess health-related quality of life using the PROMIS Global Health 10 item questionnaire
timeFrame: 3 months
measure: Assess the number of participants who are food insecure using the Hunger VitalSign food insecurity screening tool
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Assess number of participants experiencing depression using the Patient Health Questionnaire (PHQ-9) screener tool
timeFrame: 3 months
measure: Assess participants perceived self-efficacy using the PROMIS Self-Efficacy for Managing Medications and Treatments 4a questionnaire
timeFrame: 3 months
measure: Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)
timeFrame: 3 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico, Internal Medicine/Epidemiology, Biostatistics & Preventive Medicine
name: Jean A McDougall, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: