Food InsecurityFIOncNCT05176743
Food Insecurity in Oncology
A study testing Unconditional Cash Transfer (UCT) in people with Food Insecurity and Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Food Insecurity, Cancer
- What is being tested?
- Unconditional Cash Transfer (UCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87102
About this study
Official title: Food Insecurity in Oncology (FIOnc)
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.
Read the detailed 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.
- Conditions
- Food Insecurity, Cancer
- Being tested
- Unconditional Cash Transfer (UCT)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconditional Cash Transfer (UCT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | * Referral to services
* Nutrition pamphlets
* One-time payment of $300 paid 4 months after baseline Receives: Behavioral: Unconditional Cash Transfer (UCT) |
| Unconditional Cash Transfer Intervention | Experimental | * Three monthly payments of $100
* Referral to services
* Nutrition pamphlets Receives: Behavioral: Unconditional Cash Transfer (UCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so
Measured: 3 months
Determine the percentage of patients who complete both the baseline and 3 month follow-up survey
Measured: 3 months
Determine the number of participants who complete the surveys
Measured: 3 months
Secondary outcomes (9)
Assess healthcare resource utilization using the PhenX-Access to Health Services toolkit
Measured: 3 months
Healthcare costs
Measured: 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.
Measured: 3 months
Assess the number of participants who are food insecure using the Hunger VitalSign food insecurity screening tool
Measured: 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
Measured: 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
Measured: 3 months
Assess number of participants experiencing depression using the Patient Health Questionnaire (PHQ-9) screener tool
Measured: 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.
Measured: 3 months
Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start30 Aug 2021
- Primary completion2 Mar 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico Cancer Center, Wake Forest University Health Sciences, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jean A McDougall, PhD, MPH, Principal investigator, University of New Mexico, Internal Medicine/Epidemiology, Biostatistics & Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176743
- Sponsor's protocol ID
- INST UNM 2104
- Other IDs
- 5UG1CA189824-07
- Acronym
- FIOnc
- Status last verified
- Dec 2021
- First submitted
- 26 Aug 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Insecurity in Oncology (FIOnc)
- ClinicalTrials.gov ID
- NCT05176743
- Acronym / sponsor ID
- FIOnc / INST UNM 2104
- Conditions
- Food Insecurity, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Collaborators
- University of New Mexico Cancer Center, Wake Forest University Health Sciences, National Cancer Institute (NCI)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Behavioral: Unconditional Cash Transfer (UCT)* Referral to services * Nutrition pamphlets * One-time payment of $300 paid 4 months after baseline |
| Unconditional Cash Transfer Intervention | Experimental | Behavioral: Unconditional Cash Transfer (UCT)* Three monthly payments of $100 * Referral to services * Nutrition pamphlets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Unconditional Cash Transfer Intervention, Usual Care |
Primary outcome
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
9 secondary outcomes
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
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
Time frame: 3 months
Assess incidence of participant stress using the Perceived Stress Scale (PSS-10)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean A McDougall, PhD, MPH principal investigator
University of New Mexico, Internal Medicine/Epidemiology, Biostatistics & Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unconditional Cash Transfer (UCT) in people with Food Insecurity and Cancer, run by New Mexico Cancer Research Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the percentage of referred patients who are eligible to enroll in the study and choose to do so (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.