Guaranteed Income and Financial Treatment (GIFT)
March 21, 2026 updated by: Meredith Doherty, PhD, LCSW
Guaranteed Income and Financial Treatment Trial
The goal of this clinical trial is to learn if providing advanced cancer patients with $1000/month for 12 months will improve cancer outcomes. The main questions it aims to answer are:
To what extent does receiving $1000/month additional income reduce financial hardship? To what extent does receiving $1000/month additional income improve quality of life? Does receiving $1000/month additional income improve survival outcomes?
Participants will:
Receive $1000/month for 12 months Complete a survey every 3 months for 12 months If selected, participate in semi-structured interviews about their financial behaviors
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Cancer-related financial hardship (i.e., financial toxicity) has been associated with anxiety and depression, greater pain and symptom burden, treatment nonadherence, and mortality.
Out-of-pocket healthcare costs and lost income are primary drivers of financial toxicity, however, income loss is a pronounced risk factor for cancer patients with low incomes.
There has been little progress in developing an income intervention to alleviate financial toxicity cancer patients with low incomes.
Unconditional cash transfers (UCT), or guaranteed income, have produced positive health effects in experiments with general low-income populations, but have not yet been evaluated in people with cancer.
The Guaranteed Income and Financial Treatment (GIFT) Trial will use a two-arm randomized controlled trial to compare the efficacy of a 12-month UCT intervention providing $1000/month to treatment as usual on financial toxicity, health-related quality of life and treatment adherence in people with cancer who have low-incomes.
The study will recruit 250 Medicaid beneficiaries with advanced cancer from two comprehensive cancer centers in Philadelphia, obtain informed consent, and randomize patients to one of two conditions: (1) $1,000/month UCT or (2) treatment as usual.
Both arms will receive information on financial toxicity and the contact information for their hospital social worker or financial advocate upon enrollment.
Participants will complete online surveys at baseline, 3, 6, 9, and 12 months from enrollment to collect patient-reported data on primary (i.e., financial toxicity, health-related quality of life, and treatment adherence) and secondary outcomes (i.e., anxiety, depression, food insecurity, housing stability).
Social security records will be used to explore the effect on mortality at 2, 3, and 5 years post-enrollment.
Linear mixed-models will be used to analyze all primary and secondary continuous outcomes over time and general estimating equations with a logit link and binary distribution for all binary outcomes over time.
Differences between treatment and control groups and treatment effects will be determined using models that control for age, gender, race, baseline food security, baseline housing stability, and baseline ECOG.
Findings from this study will have significant implications for the development and implementation of programs and policies that address the financial burden of cancer and other serious illnesses.
Study Type
Interventional
Enrollment (Estimated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Philadelphia, New York, United States, 19107
- Pennsylvania Hospital
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
-
Philadelphia, Pennsylvania, United States, 19107
- Jefferson Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age = 18 or older
- Newly diagnosed or recurrent advanced cancer (Stage 3 or 4)
- Receiving chemotherapy or immunotherapy (with or without radiation) at one of the recruitment sites
- Within 12 months of receiving systemic therapy and on surveillance at one of the recruitment sites
- ECOG performance status of 1 - 2
- A Pennsylvania Medicaid beneficiary
- A Pennsylvania resident
Exclusion Criteria:
- Eligible for hospice (i.e. determined by provider to have a prognosis of 6 months or less) at time of randomization
- Unable to communicate in English, Spanish, or Mandarin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention arm
Participants assigned to the intervention arm receive $1000/month for 12 months
|
$1000/month for 12 months
|
|
Other: Control arm
Participants assigned to the control arm receive information on financial toxicity and the contact information for their social workers and financial counselors
|
Information on financial toxicity and contact information for social worker and financial counselor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Financial Toxicity
Time Frame: 6 and 12 months from enrollment
|
COmprehensive Score for Financial Toxicity (COST)
|
6 and 12 months from enrollment
|
|
Treatment adherence
Time Frame: 6 and 12 months from enrollment
|
Number of missed appointments in last 30 days
|
6 and 12 months from enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life
Time Frame: 6 and 12 months from enrollment
|
Short Form Health Survey (SF-36)
|
6 and 12 months from enrollment
|
|
Anxiety and Depression
Time Frame: 6 and 12 months from enrollment
|
HADS
|
6 and 12 months from enrollment
|
|
Health-related quality of life
Time Frame: 6 and 12 months from enrollment
|
The Functional Assessment of Cancer Therapy (FACT-G)
|
6 and 12 months from enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 2, 3, and 5 years from enrollment
|
survival time from enrollment
|
2, 3, and 5 years from enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Meredith Doherty, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Actual)
July 30, 2025
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
April 17, 2024
First Submitted That Met QC Criteria
September 20, 2024
First Posted (Actual)
September 25, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2026
Last Update Submitted That Met QC Criteria
March 21, 2026
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC # 31921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.