Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
Purpose
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
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Concord, New Hampshire 03301
Manchester, New Hampshire 03103
New York, New York 10004
Fargo, North Dakota 58102
Spartanburg, South Carolina 29303
San Juan, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Alliance Foundation Trials, LLC.
Study Contact
AFT Quality Management Group Inbox617-732-8727
clinicaltrials.queries@alliancefoundationtrials.org
Detailed Description
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.