Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611982
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-17
Brief Title:
Guaranteed Income and Financial Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Guaranteed Income and Financial Treatment Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GIFT
Brief Summary:
The goal of this clinical trial is to learn if providing advanced cancer patients with 1000month for 12 months will improve cancer outcomes The main questions it aims to answer are
To what extent does receiving 1000month additional income reduce financial hardship To what extent does receiving 1000month additional income improve quality of life Does receiving 1000month additional income improve survival outcomes
Participants will
Receive 1000month for 12 months Complete a survey every 3 months for 12 months If selected participate in semi-structured interviews about their financial behaviors
To what extent does receiving 1000month additional income reduce financial hardship To what extent does receiving 1000month additional income improve quality of life Does receiving 1000month additional income improve survival outcomes
Participants will
Receive 1000month 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 ie 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 1000month 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 1000month 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 ie financial toxicity health-related quality of life and treatment adherence and secondary outcomes ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None