Food Insecurity in Oncology

Study Overview
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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.

Official Title
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Food Insecurity in Oncology (FIOnc)

Conditions
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Food Insecurity, Cancer

Intervention / Treatment
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* Behavioral: Unconditional Cash Transfer (UCT)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |