Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

Malignant Solid Neoplasm Clinical Trial

Official title:

Effectiveness of Out-of-Pocket Cost COMmunication and Financial Navigation (CostCOM) in Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295367
• Other study ID #: EAQ222CD
• Secondary ID: NCI-2023-09944EA
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: August 1, 2029

Study information

• Verified date: March 2024
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVE: I. To compare patient-reported cost-related cancer care non-adherence at 12 months after completion of baseline survey between the enhanced usual care (EUC) and CostCOM study arms. SECONDARY OBJECTIVES: I. To compare patient-reported material financial hardship at 12 months after completion of baseline survey between the EUC and CostCOM study arms. II. To compare patient-reported financial worry at 12 months after completion of baseline survey between the EUC and CostCOM study arms. III. To compare patient-reported quality of life at 12 months after completion of baseline survey between the EUC and CostCOM study arms. IV. To compare patient satisfaction with care at 12 months after completion of baseline survey between the EUC and CostCOM study arms. EXPLORATORY OBJECTIVES: I. To describe CostCOM (Arm B) patients and their provider experience with various implementation outcomes. II. To assess accuracy of out-of-pocket estimates communicated with the CostCOM (Arm B) patients at part of the intervention with their reported actual out-of-pocket cost. III. To compare neighborhood characteristics of patient participants versus (vs.) practice patient population. IV. To assess patients' satisfaction with CostCOM in patients with Arm B. V. To assess patients' receipt of financial navigation via internal practice or external resources. VI. To evaluate longitudinal changes in cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care. OUTLINE: Non-patient participants: Participants complete surveys and participant in 1 on 1 in depth semi-structured interview over 20-30 minutes at 15-39 months after first patient enrollment. Patients are randomized to 1 of 2 arms. ARM A: Patients receive Patient Advocate Foundation (PAF) brochure describing financial navigation services. ARM B: Patients receive usual financial care per practice standard of care and CostCOM financial counseling sessions over 1 hour within 30 days after enrollment and at 3, 6 and 12 months. Patients are followed up within 12 months of study intervention completion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: August 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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
• NON-PATIENTS PARTICIPANTS: Participant must be one of the following:
• A study coordinator with a role involving use of CostCOM intervention price transparency and financial navigation platform
• A practice oncology provider (i.e., physician or mid-level), or
• A practice financial counselor, social workers, financial navigators, or pharmacist who have provided care or been in contact (in the last 3 months) to a patient who was assigned to the CostCOM arm, and who completed the at least 6 month study follow-up
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be = 18 years of age
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be fluent in written and spoken English OR patient must be fluent in written and spoken Spanish
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must be within 120 days of a new diagnosis of any solid cancer of any stage at the time of Step 0
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have had their first medical oncology visit at the time of Step 0
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have initiated oral or intravenous (IV) cancer systemic therapy or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not have indolent cancer undergoing observation alone (i.e., active surveillance)
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patients must not be receiving palliative or hospice care alone
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be undergoing curative surgery alone or radiation therapy alone. (Must be receiving systemic therapy), unless they are receiving systemic therapy
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must confirm that they intend to receive their care or monitoring at one of the participating NCORP practices
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must have the ability to understand and the willingness to sign a written informed consent document.
• Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not have an Eastern Cooperative Oncology Group (ECOG) performance status = 3, OR
• Patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice)
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in treatment clinical trials where cancer systemic therapy is provided at no cost to the patient
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in EAQ221CD or S1912CD given financial navigation is offered as part of these two trials.
• NOTE: If S1912CD is activated in a participating practice, S1912CD should be offered first to patients with metastatic cancer meeting eligibility criteria for S1912CD. Only if a patient is not eligible or not interested in participating in S1912CD, the EAQ222CD can be offered. For early stage cancer, EAQ222CD can be offered first given S1912CD does not enroll patients with early stage cancer
• PATIENT ELIGIBILITY CRITERIA FOR STEP 0 (OPEN SCREENING REGISTRATION): Patient must not be enrolled in other clinical trials where OOPC communication or financial navigation (i.e., professional guidance to identify financial assistance programs to alleviate cost of care) is being offered as part of the trial
• NOTE: If a trial is offering financial counseling alone without financial navigation patients are allowed to co-enroll
• NOTE: Gift cards for survey completion, or parking passes are not considered financial navigation
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must meet all the eligibility criteria for step 0
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have signed a written informed consent form
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patient must have a completed baseline survey in ECOG American College of Radiology Imaging Network Systems for Easy Entry of Patient Reported Outcomes (EASEE-PRO) within 30 days of the date of OPEN registration and consent (step 0)
• PATIENT ELIGIBILITY CRITERIA FOR STEP 1 (OPEN RANDOMIZATION): Patients must have initiated their cancer treatment (i.e., IV or oral systemic therapy) either before or within 30 days of the date of OPEN registration and consent (step 0)

Related Conditions & MeSH terms

• Malignant Solid Neoplasm

Intervention

Other:
• Best Practice
Receive PAF brochure describing financial navigation services
• Financial Navigation
Receive CostCOM financial counseling
• Interview
Participate in a 1 on 1 in-depth interview
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Saint Anthony's Health	Alton	Illinois
United States	Saint Louis Cancer and Breast Institute-Ballwin	Ballwin	Missouri
United States	Strecker Cancer Center-Belpre	Belpre	Ohio
United States	Central Care Cancer Center - Bolivar	Bolivar	Missouri
United States	Cox Cancer Center Branson	Branson	Missouri
United States	Saint Mary's Hospital	Centralia	Illinois
United States	Adena Regional Medical Center	Chillicothe	Ohio
United States	Mount Carmel East Hospital	Columbus	Ohio
United States	Mount Carmel Health Center West	Columbus	Ohio
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	Central Ohio Breast and Endocrine Surgery	Gahanna	Ohio
United States	Central Care Cancer Center - Garden City	Garden City	Kansas
United States	Central Care Cancer Center - Great Bend	Great Bend	Kansas
United States	Mount Carmel Grove City Hospital	Grove City	Ohio
United States	Zangmeister Center Grove City	Grove City	Ohio
United States	Freeman Health System	Joplin	Missouri
United States	Mercy Hospital Joplin	Joplin	Missouri
United States	Fairfield Medical Center	Lancaster	Ohio
United States	Saint Rita's Medical Center	Lima	Ohio
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	Marietta Memorial Hospital	Marietta	Ohio
United States	Memorial Hospital	Marysville	Ohio
United States	Good Samaritan Regional Health Center	Mount Vernon	Illinois
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Mount Carmel New Albany Surgical Hospital	New Albany	Ohio
United States	Licking Memorial Hospital	Newark	Ohio
United States	Newark Radiation Oncology	Newark	Ohio
United States	Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma
United States	Lake Regional Hospital	Osage Beach	Missouri
United States	Mercy Health Perrysburg Cancer Center	Perrysburg	Ohio
United States	Southern Ohio Medical Center	Portsmouth	Ohio
United States	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri
United States	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Mercy Hospital Saint Louis	Saint Louis	Missouri
United States	Mercy Hospital South	Saint Louis	Missouri
United States	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Mercy Hospital Springfield	Springfield	Missouri
United States	Springfield Regional Cancer Center	Springfield	Ohio
United States	Springfield Regional Medical Center	Springfield	Ohio
United States	Mercy Health - Saint Anne Hospital	Toledo	Ohio
United States	Saint Vincent Mercy Medical Center	Toledo	Ohio
United States	Mercy Hospital Washington	Washington	Missouri
United States	Saint Ann's Hospital	Westerville	Ohio
United States	Clinton Memorial Hospital	Wilmington	Ohio
United States	Genesis Healthcare System Cancer Care Center	Zanesville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	At 3, 6 and 12 months
Other	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.	Up to 12 months
Other	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)	39 months after enrollment of first study participant
Other	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	12 months
Other	Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care	Cost-related cancer care outcomes of non-adherence, material hardship, financial worry, quality of life and satisfaction with care (reported above) are included in a Regression Model (GEE)	At baseline and at 3, 6 and 12 months
Other	longitudinal changes in cost-related cancer care non-adherence	The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.; 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	At baseline, 3, 6 and 12 months
Other	longitudinal changes in cost-related cancer care material hardship	The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.; Material hardship 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).	At baseline, 3, 6 and 12 months
Other	longitudinal changes in cost-related cancer care financial worry	The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.; Financial Worry measured by the 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.	At baseline, 3, 6 and 12 months
Other	longitudinal changes in cost-related cancer care quality of life	The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcomes non-adherence, material hardship, financial worry, quality of life, and satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.; Quality of life is measured using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS-10) ver 1.2 Global Health. A T-score will be calculated for each 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 base	At baseline, 3, 6 and 12 months
Other	longitudinal changes in cost-related cancer care satisfaction with care	The effect of time (unitless Betas (slope)) will be estimated using a regression model (stage-stratified GEE analyses) for the Cost-related Outcome Satisfaction with care Regression intervention parameter (COSTCOM v EUC) will use EUC as the reference category.; Satisfaction with the care is measured using the 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.	At baseline, 3, 6 and 12 months
Primary	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.	12 months
Secondary	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.	at 12 months
Secondary	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.	At baseline and at 3, 6 and 12 months
Secondary	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.	At baseline and at 3, 6 and 12 months
Secondary	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.	At baseline and at 3, 6 and 12 months