An interventional study of Unconditional Cash Transfer (UCT) in Food Insecurity and Cancer, sponsored by New Mexico Cancer Research Alliance. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by New Mexico Cancer Research Alliance · Not applicable, Interventional, and Supportive care
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.
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.
9,617 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 44 is below the median of 50 across 7,432 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
* Referral to services * Nutrition pamphlets * One-time payment of $300 paid 4 months after baseline
Behavioral: Unconditional Cash Transfer (UCT)
* 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.
Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so
Time frame: 3 months
Determine the percentage of patients who complete both the baseline and 3 month follow-up survey
Time frame: 3 months
Determine the number of participants who complete the surveys
Time frame: 3 months
Assess healthcare resource utilization using the PhenX-Access to Health Services toolkit
Time frame: 3 months
Healthcare costs
Time frame: 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.
Time frame: 3 months
Assess the number of participants who are food insecure using the Hunger VitalSign food insecurity screening tool
Time frame: 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
Time frame: 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
Time frame: 3 months
Assess number of participants experiencing depression using the Patient Health Questionnaire (PHQ-9) screener tool
Time frame: 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.
Time frame: 3 months
Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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New Mexico Cancer Research Alliance