Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer

NCT ID: NCT06963723

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2029-04-01

Brief Summary

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The study aims to determine whether monthly remote digital financial hardship screening among adults with advanced/metastatic cancer, undergoing outpatient systemic therapy with non-curative intent, improves patient-centered outcomes, including financial worry, health-related quality of life (HRQoL), symptom burden, patient-reported cancer treatment adherence, and exploratory outcomes of overall survival, patient-reported economic burden, patient-reported support received, patient-reported financial coping strategies, and health insurance literacy.

Detailed Description

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Financial hardship is a common problem that affects patients treated for advanced cancer and leads to poor outcomes related to financial worry, health related quality of life (HRQoL), symptom burden, treatment adherence, and overall survival. Prior studies have shown that financial navigation may be an effective strategy to attenuate the impact of financial hardship. However, patients and clinicians have identified communication as a key barrier that prevents patients from being connected to sources of financial assistance. To address this critical gap in patient care, and based on strong preliminary data that financial hardship screening may improve patient outcomes, this financial hardship screening intervention will help connect patients to financial navigation resources. It is hypothesized that by connecting patients experiencing financial hardship with financial navigation resources, this intervention will lead to improved patient-centered outcomes.

Conditions

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Advanced Cancer Metastatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 Type EXPERIMENTAL

Financial Hardship Screening

Intervention Type OTHER

Financial Hardship Screening and Financial Needs Assessment

Enhanced Usual Care

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

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type OTHER

Enhanced Usual Care

Interventions

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Financial Hardship Screening

Financial Hardship Screening and Financial Needs Assessment

Intervention Type OTHER

Enhanced Usual Care

Enhanced Usual Care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Minimum age of 21
2. Understands English and/or Spanish
3. Has a diagnosis of advanced/metastatic cancer
4. Currently undergoing systemic therapy (enteral or parenteral) with non-curative intent
5. Has been receiving treatment for at least 2 months
6. Life expectancy of at least 6 months, in the opinion of the treating oncologist
7. Cognitively able to give informed consent

Exclusion Criteria

1. Under the age of 21
2. Does not understand English or Spanish
3. Has cognitive deficits that would preclude understanding of consent form and/or questionnaires
4. Undergoing treatment with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer, primary curative therapy for testis cancer or lymphoma)
5. Not undergoing systemic therapy (enteral or parenteral) with non-curative intent
6. Receiving treatment for fewer than 2 months
7. Life expectancy is less than 6 months, in the opinion of the treating oncologist
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

Alliance Foundation Trials, LLC.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria Blinder, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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New Hampshire Oncology-Hematology, PA

Concord, New Hampshire, United States

Site Status RECRUITING

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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AFT Quality Management Group Inbox

Role: CONTACT

617-732-8727

Other Identifiers

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A232403

Identifier Type: -

Identifier Source: org_study_id

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