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.
Brief Title
Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-732-8727
Central Contact Email
clinicaltrials.queries@alliancefoundationtrials.org
Completion Date
Completion Date Type
Estimated
Conditions
ADVANCED CANCER
METASTATIC CANCER
Eligibility Criteria
Inclusion Criteria:
1. 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:
1. 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
1. 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:
1. 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
Inclusion Criteria
Inclusion Criteria:
1. 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
1. 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
Gender
All
Gender Based
false
Keywords
Financial Toxicity
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT06963723
Org Class
Other
Org Full Name
Alliance Foundation Trials, LLC.
Org Study Id
A232403
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Longitudinal Screening for Financial Hardship to Improve Outcomes in Patients With Advanced Cancer
Primary Outcomes
Outcome Description
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
Possible score range: 0 to 44, with higher scores indicating better outcomes
Outcome Measure
Financial Worry
Outcome Time Frame
6 months
Secondary Outcomes
Outcome Description
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
Possible score range: 0 to 108, with higher scores indicating better outcomes
Outcome Time Frame
6 months
Outcome Measure
Health-related quality of life
Outcome Description
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
Possible score range: 0 to 28, with higher scores indicating better outcomes
Outcome Time Frame
6 months
Outcome Measure
Symptom burden
Outcome Description
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
Outcome Time Frame
6 months
Outcome Measure
Cancer treatment adherence
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Cancer --- NEOPLASMS
Mental Health & Behavioral Research --- BEHAVIORAL SYMPTOMS
Psychiatry & Behavioral Sciences --- BEHAVIORAL SYMPTOMS
MeSH Terms
NEOPLASM METASTASIS
FINANCIAL STRESS
NEOPLASTIC PROCESSES
NEOPLASMS
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
STRESS, PSYCHOLOGICAL
BEHAVIORAL SYMPTOMS
BEHAVIOR