Health TrialsbyHealthPanel

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

ConditionsAdvanced CancerMetastatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAlliance Foundation Trials, LLC.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Financial Hardship Screening

    Other intervention

    Financial Hardship Screening and Financial Needs Assessment

  • Enhanced Usual Care

    Other intervention

    Enhanced Usual Care

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention

Trial outcomes

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

Time frame
6 months

Secondary outcomes

1

Health-related quality of life

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

Time frame
6 months
2

Symptom burden

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

Time frame
6 months
3

Cancer treatment adherence

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

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alliance Foundation Trials, LLC.

Lead sponsor

Memorial Sloan Kettering Cancer Center

Collaborator

Source ClinicalTrials.gov
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