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Completed

NCT Number: NCT05176743

Food Insecurity in Oncology

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.

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Key information

Conditions

Food Insecurity Cancer Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, 87102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unconditional Cash Transfer (UCT)

Behavioral

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.

Primary outcomes

  1. Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so

    Time frame: 3 months

  2. Determine the percentage of patients who complete both the baseline and 3 month follow-up survey

    Time frame: 3 months

  3. Determine the number of participants who complete the surveys

    Time frame: 3 months

Secondary outcomes

  1. Assess healthcare resource utilization using the PhenX-Access to Health Services toolkit

    Time frame: 3 months

  2. Healthcare costs

    Time frame: 3 months

  3. Assess health-related quality of life using the PROMIS Global Health 10 item questionnaire

    Time frame: 3 months

    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.

  4. Assess the number of participants who are food insecure using the Hunger VitalSign food insecurity screening tool

    Time frame: 3 months

  5. 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

  6. 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

  7. Assess number of participants experiencing depression using the Patient Health Questionnaire (PHQ-9) screener tool

    Time frame: 3 months

  8. Assess participants perceived self-efficacy using the PROMIS Self-Efficacy for Managing Medications and Treatments 4a questionnaire

    Time frame: 3 months

    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.

  9. Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

New Mexico Cancer Research Alliance

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of New Mexico Cancer Center
  • Wake Forest University Health Sciences

Registry information

Official study title

Food Insecurity in Oncology (FIOnc)

Acronym: FIOnc

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 4, 2022
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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