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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Hardship Screening | Other | Financial Hardship Screening and Financial Needs Assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Symptom burden |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AFT Quality Management Group Inbox | Contact | 617-732-8727 | clinicaltrials.queries@alliancefoundationtrials.org |
| Name | Affiliation | Role |
|---|---|---|
| Victoria Blinder, MD, MSc | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dignity Health | Recruiting | Phoenix | Arizona | 85004 | United States |
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| Enhanced Usual Care | Other | Enhanced Usual Care |
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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 |
| 6 months |
| 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 | 6 months |
| New Hampshire Oncology-Hematology, PA | Recruiting | Concord | New Hampshire | 03301 | United States |
| Solinsky Center for Cancer Care | Recruiting | Manchester | New Hampshire | 03103 | United States |
| New York City Health and Hospitals | Recruiting | New York | New York | 10004 | United States |
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| Sanford Health | Recruiting | Fargo | North Dakota | 58102 | United States |
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| Gibbs Cancer Center | Recruiting | Spartanburg | South Carolina | 29303 | United States |
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| Pan American Center for Oncology Trials | Recruiting | San Juan | 00935 | Puerto Rico |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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