Guaranteed Income for Cancer Patients

(GIFT Trial)

Recruiting at 2 trial locations

Overseen By Meredith Doherty, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Meredith Doherty

Must be taking: Chemotherapy, Immunotherapy

Disqualifiers: Hospice eligible, Language barrier

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on financial support rather than medication changes.

What data supports the effectiveness of the treatment Guaranteed Income for Cancer Patients?

The Guaranteed Income and Financial Treatment (GIFT) trial is studying if giving $1,000 a month to low-income cancer patients can reduce financial stress and improve their quality of life. Similar programs have shown positive health effects in general low-income populations, suggesting potential benefits for cancer patients. ^{1 2 3 4 5}

Is guaranteed income safe for cancer patients?

The research on guaranteed income, also known as unconditional cash transfers, has shown positive health effects in general low-income populations, but it has not yet been specifically evaluated for safety in people with cancer. ^{1 3 6 7 8}

How does the Guaranteed Income treatment differ from other treatments for cancer patients?

The Guaranteed Income treatment is unique because it provides monthly unconditional cash payments to cancer patients with low incomes to reduce financial stress, unlike traditional treatments that focus on medical or pharmaceutical interventions. ^{1 3 9 10 11}

What is the purpose of this 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

Research Team

Meredith Doherty

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for advanced cancer patients experiencing financial hardship. Participants will receive $1000 monthly for a year and complete surveys every 3 months. Some may also be interviewed about their finances.

Inclusion Criteria

1. Age = 18 or older

2. Newly diagnosed or recurrent advanced cancer (Stage 3 or 4)

3. Receiving chemotherapy or immunotherapy (with or without radiation) at one of the recruitment sites

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive $1000/month for 12 months

12 months

Surveys at baseline, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for financial toxicity, quality of life, and treatment adherence

12 months

Surveys at 6 and 12 months

Long-term Follow-up

Social security records used to explore mortality effects

5 years

Treatment Details

Interventions

• Guaranteed Income

Trial Overview The study tests if an extra $1000 per month can reduce financial stress, improve quality of life, and potentially enhance survival outcomes in advanced cancer patients.

Participant Groups

Group I: Intervention arm Experimental Treatment 1 Intervention

Participants assigned to the intervention arm receive $1000/month for 12 months

Group II: Control arm Experimental Treatment 1 Intervention

Participants assigned to the control arm receive information on financial toxicity and the contact information for their social workers and financial counselors

Guaranteed Income is already approved in United States for the following indications:

Approved in United States as Guaranteed Income for:

• Homelessness prevention
• Housing stability support
• Financial assistance for low-income families

Who Is Running the Clinical Trial?

Meredith Doherty

Lead Sponsor

Trials

1

Recruited

250+

Mathematica Policy Research, Inc.

Collaborator

Trials

68

Recruited

31,130,000+

Findings from Research

The Guaranteed Income and Financial Treatment (GIFT) Trial will evaluate the impact of a 12-month unconditional cash transfer of $1,000 per month on financial toxicity and health-related quality of life in 250 low-income cancer patients, aiming to address the financial burdens associated with cancer treatment.

This study is significant as it explores a novel intervention—unconditional cash transfers—specifically for cancer patients, which has shown positive health effects in other low-income populations but has not been previously tested in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guaranteed Income and Financial Treatment (G.I.F.T.): a 12-month, randomized controlled trial to compare the effectiveness of monthly unconditional cash transfers to treatment as usual in reducing financial toxicity in people with cancer who have low incomes. Doherty, M., Heintz, J., Leader, A., et al.[2023]

A study of 664 female breast cancer patients in China revealed a median financial toxicity score of 21, indicating significant financial strain related to healthcare costs, particularly for those with stage IV cancer or lower household income.

Nearly half of the patients reported using coping strategies such as delaying treatment or not following medical advice, highlighting the need for oncologists and policymakers to address financial burdens to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial toxicity in female patients with breast cancer: a national cross-sectional study in China. Liu, M., Hu, L., Han, X., et al.[2022]

A welfare rights advice intervention for cancer patients and their carers significantly increased income, with a 96% success rate in benefit claims, resulting in a median weekly income increase of £70.30.

The intervention not only alleviated financial stress but also improved overall well-being and quality of life by helping patients manage costs associated with cancer, highlighting the importance of integrating financial support services in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the financial consequences of cancer: qualitative evaluation of a welfare rights advice service. Moffatt, S., Noble, E., White, M.[2021]

In a study of 210 breast cancer patients in a lower- to middle-income country, 81% reported significant financial toxicity, indicating a high level of financial strain due to their cancer diagnosis.

Key contributors to financial toxicity included travel costs (94%), out-of-hospital investigations (87%), and consultation fees (81), leading many patients to make daily compromises in basic needs like food and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer-Related Financial Toxicity in Sri Lanka: Insights From a Lower Middle-Income Country With Free Universal Public Healthcare. Ranawaka, S., Gunarathna, S., Gunasekera, S., et al.[2023]

The NCI and NIH have allocated $50 million over 5 years to five university-based centers to enhance cancer outcomes in low-income areas through targeted research and programs.

The initiative focuses on engaging patients in cancer prevention strategies, including lifestyle changes like smoking cessation, healthy eating, and increased physical activity, to improve health in high-poverty communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticancer Initiative Targets Areas of Poverty. [2023]

Mothers of children with cancer initially had higher total incomes compared to reference mothers, but their income dropped significantly after the diagnosis, leading to lower long-term earnings as social benefits decreased over time.

Social benefits provided crucial financial support during the cancer diagnosis period, but the long-term financial impact on mothers, especially in single-parent households, raises concerns about their future career and pension outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of income and social benefits for mothers and fathers of children with cancer: A national cohort study in Sweden. Hiyoshi, A., Montgomery, S., Bottai, M., et al.[2019]

In a study of 1,294 newly diagnosed cancer patients in Malaysia, 51% experienced financial catastrophe within a year, highlighting significant financial burdens despite universal health coverage.

Factors such as low-income status, type of hospital, and lack of health insurance were strong predictors of financial toxicity, with nonmedical costs significantly contributing to the financial hardships faced by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial Toxicity After Cancer in a Setting With Universal Health Coverage: A Call for Urgent Action. Bhoo-Pathy, N., Ng, CW., Lim, GC., et al.[2020]

Multi-disciplinary stepped psycho-social care significantly reduces financial problems at discharge for cancer patients who initially reported such issues, with an odds ratio of 0.2, indicating a strong positive effect.

However, the stepped care approach did not show a significant impact on the return-to-work rates for patients under 65 years old, suggesting that while it helps with financial issues, it may not directly improve employment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of multi-disciplinary psycho-social care on socio-economic problems in cancer patients: a cluster-randomized trial. Singer, S., Roick, J., Meixensberger, J., et al.[2019]

About 60% of cancer patients survive for more than five years, but many experience reduced performance and significant income loss, averaging 26% in Germany, which can lead to socioeconomic challenges.

The concept of 'financial toxicity' arises from the financial burdens of cancer treatment, impacting patients' quality of life and potentially their disease prognosis, highlighting the need for support measures, especially for young adults with cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Socioeconomic risks for people with cancer-possible consequences and assistance]. Seifart, U.[2022]

In France, cancer patients receive full reimbursement for medical and pharmaceutical expenses, along with income support during their treatment, which helps alleviate financial burdens during recovery.

New laws have improved job security for cancer patients, allowing civil servants to take up to 5 years off for treatment without dismissal, although the return-to-work rates are lower for poorly qualified workers due to economic challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation and social reintegration of cancer patients]. Schraub, S.[2009]

Cancer patients, especially in rural areas of Kentucky, experience significant financial toxicity due to high care costs and limited health literacy, which complicates their ability to discuss and manage these costs effectively.

There is a critical need for dedicated financial navigators and improved systems for assessing and addressing financial barriers in cancer care, as current resources are insufficient to support patients in navigating their financial challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability and Accessibility of Cancer Care Delivery Approaches to Reduce Financial Toxicity of Rural and Urban Cancer Patients in Kentucky. Edward, J., Bowling, W., Chitwood, H., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Guaranteed Income and Financial Treatment (G.I.F.T.): a 12-month, randomized controlled trial to compare the effectiveness of monthly unconditional cash transfers to treatment as usual in reducing financial toxicity in people with cancer who have low incomes. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Financial toxicity in female patients with breast cancer: a national cross-sectional study in China. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Addressing the financial consequences of cancer: qualitative evaluation of a welfare rights advice service. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Breast Cancer-Related Financial Toxicity in Sri Lanka: Insights From a Lower Middle-Income Country With Free Universal Public Healthcare. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Anticancer Initiative Targets Areas of Poverty. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Trajectories of income and social benefits for mothers and fathers of children with cancer: A national cohort study in Sweden. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Financial Toxicity After Cancer in a Setting With Universal Health Coverage: A Call for Urgent Action. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

The effects of multi-disciplinary psycho-social care on socio-economic problems in cancer patients: a cluster-randomized trial. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

[Socioeconomic risks for people with cancer-possible consequences and assistance]. [2022]

10. France pubmed.ncbi.nlm.nih.gov

[Rehabilitation and social reintegration of cancer patients]. [2009]

11. United States pubmed.ncbi.nlm.nih.gov

Availability and Accessibility of Cancer Care Delivery Approaches to Reduce Financial Toxicity of Rural and Urban Cancer Patients in Kentucky. [2023]