This clinical trial evaluates the effect of Cost Communication and Financial Navigation (CostCOM) intervention on adherence to care and financial burden in cancer patients. Many cancer patients experience financial hardship due to high medical out of pocket costs (OOPC), changes in employment, income and insurance. Financial hardship can lead to a delay or a stop in cancer care, and is linked to poor quality of life. Financial navigation programs, such as CostCOM, provide financial counseling, education and connections to appropriate resources to reduce financial barriers to healthcare and minimize financial stress and burden. CostCOM may improve adherence to care and decrease financial burden in patients with cancer.
NON-PATIENTS PARTICIPANTS: Participant must speak English
NON-PATIENTS PARTICIPANTS: Participant must be employed at National Cancer Institute Community Oncology Research Program (NCORP) site for at least six months
NON-PATIENTS PARTICIPANTS: Participant must be able to provide informed consent to participate in this study
A study coordinator with a role involving use of CostCOM intervention price transparency and financial navigation platform
None
Parallel
Best Practice
Other interventionReceive PAF brochure describing financial navigation services
Financial Navigation
Other interventionReceive CostCOM financial counseling
Interview
Other interventionParticipate in a 1 on 1 in-depth interview
Survey Administration
Other interventionAncillary studies
Cost-related cancer care non-adherence
Cost-related cancer care non-adherence is defined as a positive response to any of the following due to costs: Delayed, forewent, stopped, or changed prescribed cancer medication; or delayed, forewent, or refused recommended cancer tests, or cancer office visits. Will be calculated as a report of non-adherence at any point up through the 12mo follow-up survey.
Rate of Material Financial Hardship
Rate of material hardship at each time point is a binary (yes/no) composite measure defined as a positive response to any of the following: (1) home sale, refinance or move to affordable rental, (2) loans, (3) reaching credit limits, and (4) bankruptcy because of your cancer care, or its treatment (adapted from Medical Expenditure Panel Survey).Material hardship at 12 months is measured as report of material hardship at any of the 3, 6 and 12 follow-ups.
Patient-reported financial worry
Measured by 12-item Comprehensive Score for Financial Toxicity (de Souza COST measure). Composite Scores range between 0-44 with higher the scores reflecting better the Financial Well-Being. Item 12 , an unscored summary item, will be used separately as a single item measure of financial worry. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.
Patient-reported Quality of life - mental and physical health
Measured using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS-10) version 1.2 Global Health. A T-score will be calculated for each of the global mental health and global physical health sections with a higher PROMIS T-score representing more of the concept being measured (mental/physical health). T-scores for the general population have a mean of 50 and a standard deviation (SD) of 10.Thus, a person who has T- scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.
Patient-reported satisfaction with care at 12 months
Satisfaction with the care will be measured using Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care Survey questions. Composite items are rated on a scale of 0 to 10, with 0 being the worst and 10 being the best. Mean score and changes in mean scores from baseline at each time point between the arms will be compared using two-sample t-tests.
Out of pocket cost (OOPC) accuracy
Mean absolute difference between OOPC estimates for the first cycle of therapy (as estimated by TailorMed Medical Incorporated) and the actual billed out of pocket (OOP) costs (as reported by patients based on their co-pays or medical bills).
Proportion of study patient participants that are of minority racial/ethnic background, and with public insurance will be measured and compared with that of practice patient population.
Proportion of patients with specific characteristics, including racial, ethnic, payer mix, and neighborhood deprivation indices. Proportions will be compared between study participants and practice patient population.
Patient reported satisfaction with intervention
Qualitative interviews utilizing the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework was used to guide the evaluation questions and examine the effectiveness of the intervention and implementation outcomes. Participants describe their experience with various components of the CostCOM intervention: price transparency, financial navigation, and financial counseling, barriers and facilitators to participation, and feedback on what they liked and disliked about CostCOM, how it impacted their care, satisfaction with care, and what they would change to make it more helpful or engaging. The outcome measures are the proportion of subjects in the top 10 categories identified (5 for each like and dislike)
Receipt of financial navigation via internal practice or external resources
Proportion of subjects receiving (at least 1 session) of financial navigation via study intervention, internal practice, or external resources. Receipt of financial counseling or financial assistance will be documented via treating clinic as extracted from medical records and intervention participants via reports from TailorMed Medical Incorporated
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ECOG-ACRIN Cancer Research Group
Lead sponsor
National Cancer Institute (NCI)
Collaborator
