CancerGIFTNCT06611982
Guaranteed Income and Financial Treatment
A study testing Unconditional cash transfer and Contact information for social worker and financial counselor in people with Cancer and Financial Hardship, run by Meredith Doherty, PhD, LCSW at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Financial Hardship, Quality of Life
- What is being tested?
- Unconditional cash transfer and Contact information for social worker and financial counselor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Apr 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennsylvania Hospital
Philadelphia, New York, 19107
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Jefferson Health
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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
Read the 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.
- Conditions
- Cancer, Financial Hardship, Quality of Life
- Being tested
- Unconditional cash transfer, Contact information for social worker and financial counselor
- Medical subject headings
- Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unconditional cash transferOther
$1000/month for 12 months
Contact information for social worker and financial counselorOther
Information on financial toxicity and contact information for social worker and financial counselor
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants assigned to the intervention arm receive $1000/month for 12 months Receives: Other: Unconditional cash transfer |
| Control arm | Other | Participants assigned to the control arm receive information on financial toxicity and the contact information for their social workers and financial counselors Receives: Other: Contact information for social worker and financial counselor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Financial Toxicity
COmprehensive Score for Financial Toxicity (COST)
Measured: 6 and 12 months from enrollment
Treatment adherence
Number of missed appointments in last 30 days
Measured: 6 and 12 months from enrollment
Secondary outcomes (3)
Health-related quality of life
Short Form Health Survey (SF-36)
Measured: 6 and 12 months from enrollment
Anxiety and Depression
HADS
Measured: 6 and 12 months from enrollment
Health-related quality of life
The Functional Assessment of Cancer Therapy (FACT-G)
Measured: 6 and 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Apr 2023
- Primary completion30 Jul 2025
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meredith Doherty, PhD, LCSW
- Sponsor type
- University, hospital or other
- Collaborators
- Mathematica Policy Research, Inc.
- Responsible party
- Sponsor-investigator, Meredith Doherty, PhD, LCSW, Abramson Cancer Center at Penn Medicine
- Investigators
- Meredith Doherty, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611982
- Sponsor's protocol ID
- UPCC # 31921
- Acronym
- GIFT
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guaranteed Income and Financial Treatment Trial
- ClinicalTrials.gov ID
- NCT06611982
- Acronym / sponsor ID
- GIFT / UPCC # 31921
- Conditions
- Cancer, Financial Hardship, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Meredith Doherty, PhD, LCSWUniversity, hospital or other
- Collaborators
- Mathematica Policy Research, Inc.
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 25 Sep 2024 (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.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Unconditional cash transferParticipants assigned to the intervention arm receive $1000/month for 12 months |
| Control arm | Other | Other: Contact information for social worker and financial counselorParticipants assigned to the control arm receive information on financial toxicity and the contact information for their social workers and financial counselors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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$1000/month for 12 months | Other | Intervention arm |
| Contact information for social worker and financial counselorInformation on financial toxicity and contact information for social worker and financial counselor | Other | Control arm |
Primary outcome
Financial Toxicity
Time frame: 6 and 12 months from enrollment
COmprehensive Score for Financial Toxicity (COST)
Treatment adherence
Time frame: 6 and 12 months from enrollment
Number of missed appointments in last 30 days
3 secondary outcomes
Health-related quality of life
Time frame: 6 and 12 months from enrollment
Anxiety and Depression
Time frame: 6 and 12 months from enrollment
Health-related quality of life
Time frame: 6 and 12 months from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- 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.
Meredith Doherty principal investigator
University of Pennsylvania
3 sites 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 and Contact information for social worker and financial counselor in people with Cancer and Financial Hardship, run by Meredith Doherty, PhD, LCSW at 3 sites 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 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Financial Toxicity (time frame: 6 and 12 months from enrollment). The study lists 2 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 25 Mar 2026.