Financial Hardship Screening for Cancer

(PROOF Trial)

Recruiting at 1 trial location

Overseen By AFT Quality Management Group Inbox

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alliance Foundation Trials, LLC.

Disqualifiers: Curative treatment, Cognitive deficits, others

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

Compensation: Varies

Number of Visits: Unknown

1000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how addressing financial stress can aid individuals with advanced cancer undergoing non-curative treatment. Participants will either receive regular care or complete a monthly survey about their financial concerns. The goal is to determine if these check-ins, known as Financial Hardship Screening, can alleviate financial worries and improve overall well-being. It suits those who have had advanced cancer for at least two months and are not expecting a cure from their treatment. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance the quality of life for others facing similar challenges.

What prior data suggests that financial hardship screening is safe for cancer patients?

Research shows that financial hardship screening involves no physical treatments or medications, eliminating usual safety concerns like side effects. Instead, this screening asks patients about their financial situations related to cancer treatment. Most cancer care centers already assess financial distress, often with assistance from social workers. This process is generally straightforward for patients and does not impact physical health. It serves to understand and address financial challenges that might affect a patient's quality of life and ability to adhere to their treatment plan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover how financial hardship impacts cancer patients. Unlike standard treatments that focus solely on medical care, this approach includes a monthly financial screening, identifying those who may struggle with costs related to their treatment. By understanding this aspect, the trial could lead to new strategies that support patients financially, potentially improving their overall care and well-being.

What evidence suggests that financial hardship screening is effective for improving patient-centered outcomes in cancer patients?

Research has shown that money problems affect 30–70% of cancer patients, causing increased worry and reducing their quality of life. In this trial, participants in the intervention arm will undergo monthly financial hardship screening to identify those in need of support. Studies have found that such screening effectively identifies patients requiring assistance. Addressing financial issues may improve patients' mental well-being and adherence to cancer treatment. Overall, screening for financial hardship could be a valuable method to help patients manage both their health and financial stress. ^{3 6 7 8 9}

Who Is on the Research Team?

Victoria Blinder, MD, MSc

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 21 with advanced/metastatic cancer who are undergoing non-curative systemic therapy and have been treated for at least 2 months. Participants must be cognitively able to consent, understand English or Spanish, and expected to live at least another 6 months.

Inclusion Criteria

I understand English or Spanish.

I am at least 21 years old.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm complete monthly financial hardship screening using a single-item question

12 months

Monthly remote screenings

Follow-up

Participants are monitored for outcomes such as financial worry, symptom burden, and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Financial Hardship Screening

Trial Overview The study tests if monthly remote digital screenings for financial hardship can improve outcomes like less financial worry, better quality of life, symptom management, treatment adherence, survival rates, economic burden coping strategies, support received and insurance literacy.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will complete their monthly screening using the single-item screening question (every 4 weeks for 12 months).

Group II: Enhanced Usual Care Active Control 1 Intervention

Participants randomized to receive enhanced usual care will not be systematically screened for financial hardship through the electronic PRO Core system.

Who Is Running the Clinical Trial?

Alliance Foundation Trials, LLC.

Lead Sponsor

Trials

25

Recruited

27,200+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12671931/

Challenges in delivering financial assistance after positive ... We evaluated outcomes and barriers in a systematic financial toxicity screening and referral program at a large comprehensive cancer center.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794551

Financial Hardship in Cancer Care—The Need to Define ... In the survey study by Khera et al involving more than 400 patients with cancer, the prevalence of financial hardship was high (48%-68%).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825824001598

Dedicated financial hardship screening adds value to ... A growing body of research estimates that 30–70% of cancer patients experience financial hardship (FH), highlighting the urgency of implementing FH screening ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06963723

Longitudinal Screening for Financial Hardship to Improve ... Financial hardship is a common problem that affects patients treated for advanced cancer and leads to poor outcomes related to financial worry, health related ...

5. pcori.org pcori.org/research-results/2024/comparing-longitudinal-screening-financial-hardship-usual-care-improve-health-related-financial-worry-and-quality-life-patients-advanced-cancer

Comparing Longitudinal Screening for Financial Hardship ... This study compares the clinical effectiveness of a longitudinal screening approach for financial hardship to usual care among adults ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8026561/

Current Practices for Screening and Addressing Financial ... Cancer-related financial hardship is associated with poor care outcomes and reduced quality-of-life for patients and families.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823609

Financial Hardship Among Patients With Early-Stage ... More than 50% of cancer survivors report financial hardship, characterized by 3 domains: cost-related care nonadherence, material hardship, and ...

8. uclahealth.org uclahealth.org/news/release/housing-aid-linked-lower-medical-financial-hardship-among-us

Housing aid linked to lower medical financial hardship ... Government housing assistance was associated with a nearly seven-percentage point lower risk of experiencing financial hardship related to ...

9. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00902

Screening and Referral for Health-Related Social Needs ... Most oncology practices reported screening for financial distress (78%). Social worker evaluation was the most common method used to screen for ...