Food Insecurity in Oncology

Cancer Clinical Trial

— FIOnc  

Official title:

Food Insecurity in Oncology (FIOnc)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05176743
• Other study ID #: INST UNM 2104
• Secondary ID: 5UG1CA189824-07
• Status: Completed
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: June 20, 2022

Study information

• Verified date: December 2021
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 20, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Food Insecurity

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico

Sponsors (4)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance	National Cancer Institute (NCI), University of New Mexico Cancer Center, Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so		3 months
Primary	Determine the percentage of patients who complete both the baseline and 3 month follow-up survey		3 months
Primary	Determine the number of participants who complete the surveys		3 months
Secondary	Assess healthcare resource utilization using the PhenX-Access to Health Services toolkit		3 months
Secondary	Healthcare costs		3 months
Secondary	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
Secondary	Assess the number of participants who are food insecure using the Hunger VitalSign food insecurity screening tool		3 months
Secondary	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
Secondary	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
Secondary	Assess number of participants experiencing depression using the Patient Health Questionnaire (PHQ-9) screener tool		3 months
Secondary	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
Secondary	Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)		3 months