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NCT Number: NCT06963723

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

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.

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Key information

Conditions

Advanced Cancer Behavior Behavioral Symptoms Financial Stress Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Stress, Psychological

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pan American Center for Oncology Trials, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Financial Hardship Screening

Other

Financial Hardship Screening and Financial Needs Assessment

Enhanced usual care

Other

Enhanced Usual Care

Primary outcomes

  1. Financial Worry

    Time frame: 6 months

    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

Secondary outcomes

  1. Health-related quality of life

    Time frame: 6 months

    Patient-reported health-related quality of life will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) total scale.

    Possible score range: 0 to 108, with higher scores indicating better outcomes

  2. Symptom burden

    Time frame: 6 months

    Patient-reported symptom burden will be measured by the Functional Assessment of Cancer Therapy-General (FACT-G) physical well-being scale.

    Possible score range: 0 to 28, with higher scores indicating better outcomes

  3. Cancer treatment adherence

    Time frame: 6 months

    Patient-reported cancer treatment adherence will be measured by the Domains of Subjective Extent of Nonadherence-Cancer (DOSE-Nonadherence-Cancer) extent of nonadherence scale, with patients classified as adherent (i.e., all responses of "none of the time" on the DOSE-Nonadherence-Cancer items for missing, skipping, or not taking a dose of medicine) versus nonadherent

Study contacts

Contact information is provided by the study sponsor or research team.

AFT Quality Management Group Inbox

CONTACT

[email protected]

617-732-8727

Sponsors and collaborators

Lead sponsor

Alliance Foundation Trials, LLC.

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Acronym: PROOF

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 9, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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