Recruiting

Observational Study

Sponsor:

Alliance Foundation Trials, LLC.

Code:

NCT06963723

Conditions

Advanced Cancer

Metastatic Cancer

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Financial Hardship Screening

Enhanced Usual Care

Study Details

Brief summary:

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.

Conditions

Advanced Cancer

Metastatic Cancer

Study ID

NCT06963723

Start date

Jul 1, 2025

Status verified date

May, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention

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

active comparator: Enhanced Usual Care

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

Interventions

Financial Hardship Screening

Financial Hardship Screening and Financial Needs Assessment

Enhanced Usual Care

Enhanced Usual Care

Primary outcome measure

  • Financial Worry [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

AFT Quality Management Group Inbox

617-732-8727clinicaltrials.queries@alliancefoundationtrials.org

Locations

Dignity Health

Recruiting

Phoenix, Arizona, United States, 85004

Contacts

Vamsee Torri, MD

vamsee.torri@commonspirit.org

New Hampshire Oncology-Hematology, PA

Recruiting

Concord, New Hampshire, United States, 03301

Solinsky Center for Cancer Care

Recruiting

Manchester, New Hampshire, United States, 03103

New York City Health and Hospitals

Recruiting

New York, New York, United States, 10004

Contacts

Debra Ferman, MD

FERMAND@nychhc.org

Sanford Health

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Samuel Milanovitch, MD

701-234-6161samuel.milanovich@sanfordhealth.org

Gibbs Cancer Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Amarinthia Curtis, MD

864-560-6812acurtis@gibbscc.org

More Information

Sponsor

Alliance Foundation Trials, LLC.

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Financial Toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alliance Foundation Trials, LLC. on 2026-05-12.