Food Insecurity in Oncology (FIOnc)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
No blinding will be used in this pilot trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
- •Able to speak English or Spanish
- •Food insecure
排除标准
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
研究组 & 干预措施
Usual Care
- Referral to services
- Nutrition pamphlets
- One-time payment of $300 paid 4 months after baseline
干预措施: Unconditional Cash Transfer (UCT) (Behavioral)
Unconditional Cash Transfer Intervention
- Three monthly payments of $100
- Referral to services
- Nutrition pamphlets
干预措施: Unconditional Cash Transfer (UCT) (Behavioral)
结局指标
主要结局
Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so
时间窗: 3 months
Determine the percentage of patients who complete both the baseline and 3 month follow-up survey
时间窗: 3 months
Determine the number of participants who complete the surveys
时间窗: 3 months
次要结局
- Healthcare costs(3 months)
- Assess healthcare resource utilization using the PhenX-Access to Health Services toolkit(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)
- Assess health-related quality of life using the PROMIS Global Health 10 item questionnaire(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(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 the number of participants who are food insecure using the Hunger VitalSign food insecurity screening tool(3 months)
- Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)(3 months)