NCT06963723

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Jul 2025

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Jul 2025Apr 2029

First Submitted

Initial submission to the registry

April 1, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

April 1, 2025

Last Update Submit

March 2, 2026

Conditions

Advanced CancerMetastatic Cancer

Keywords

Financial Toxicity

Outcome Measures

Primary Outcomes (1)

  • Financial Worry

    Patient-reported financial worry will be measured by the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) total scale. Possible score range: 0 to 44, with higher scores indicating better outcomes

    6 months

Secondary Outcomes (3)

  • Health-related quality of life

    6 months

  • Symptom burden

    6 months

  • Cancer treatment adherence

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Financial Hardship Screening

Enhanced Usual Care

ACTIVE COMPARATOR

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

Other: Enhanced Usual Care

Interventions

Financial Hardship ScreeningOTHER

Financial Hardship Screening and Financial Needs Assessment

Intervention
Enhanced Usual CareOTHER

Enhanced Usual Care

Enhanced Usual Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dignity Health

Phoenix, Arizona, 85004, United States

RECRUITING

New Hampshire Oncology-Hematology, PA

Concord, New Hampshire, 03301, United States

RECRUITING

Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103, United States

RECRUITING

New York City Health and Hospitals

New York, New York, 10004, United States

RECRUITING

Pan American Center for Oncology Trials

San Juan, 00935, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Neoplasm MetastasisFinancial Stress

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Victoria Blinder, MD, MSc

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AFT Quality Management Group Inbox

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2025

First Posted

May 9, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

March 4, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)PR(1)