Cost Communication and Financial Navigation in Cancer Patients (COSTCOM)

March 12, 2024 updated by: ECOG-ACRIN Cancer Research Group

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

760

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • Saint Anthony's Health
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Saint Mary's Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • Good Samaritan Regional Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-242-4600
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Saint Louis Cancer and Breast Institute-Ballwin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7058
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63109
        • Recruiting
        • Saint Louis Cancer and Breast Institute-South City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-353-1870
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Recruiting
        • Strecker Cancer Center-Belpre
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Chillicothe, Ohio, United States, 45601
        • Recruiting
        • Adena Regional Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel East Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43222
        • Recruiting
        • Mount Carmel Health Center West
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Gahanna, Ohio, United States, 43230
        • Recruiting
        • Central Ohio Breast and Endocrine Surgery
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Grove City, Ohio, United States, 43123
        • Recruiting
        • Mount Carmel Grove City Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Grove City, Ohio, United States, 43123
        • Recruiting
        • Zangmeister Center Grove City
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Lancaster, Ohio, United States, 43130
        • Recruiting
        • Fairfield Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Lima, Ohio, United States, 45801
        • Recruiting
        • Saint Rita's Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
          • Site Public Contact
          • Phone Number: 419-226-9617
      • Marietta, Ohio, United States, 45750
        • Recruiting
        • Marietta Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Marysville, Ohio, United States, 43040
        • Recruiting
        • Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Mount Vernon, Ohio, United States, 43050
        • Recruiting
        • Knox Community Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • New Albany, Ohio, United States, 43054
        • Recruiting
        • Mount Carmel New Albany Surgical Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Licking Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Newark Radiation Oncology
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Perrysburg, Ohio, United States, 43551
        • Recruiting
        • Mercy Health Perrysburg Cancer Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Portsmouth, Ohio, United States, 45662
        • Recruiting
        • Southern Ohio Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Springfield, Ohio, United States, 45504
        • Recruiting
        • Springfield Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Springfield, Ohio, United States, 45505
        • Recruiting
        • Springfield Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Saint Vincent Mercy Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Mercy Health - Saint Anne Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • Saint Ann's Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Wilmington, Ohio, United States, 45177
        • Recruiting
        • Clinton Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
          • Site Public Contact
          • Phone Number: 937-283-2273
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ARM A (Enhanced usual care)
Patients receive PAF brochure describing financial navigation services.
Other: Survey Administration
Ancillary studies
Other: Best Practice
Receive PAF brochure describing financial navigation services
Other Names:
  • standard of care
  • standard therapy
Experimental: ARM B (CostCOM)
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.
Other: Survey Administration
Ancillary studies
Other: Best Practice
Receive PAF brochure describing financial navigation services
Other Names:
  • standard of care
  • standard therapy
Other: Financial Navigation
Receive CostCOM financial counseling
Other Names:
  • Financial Navigation Program
Experimental: Non-patient participants: (interview)
Non-patient 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.
Other: Survey Administration
Ancillary studies
Other: Interview
Participate in a 1 on 1 in-depth interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-related cancer care non-adherence
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Material Financial Hardship
Time Frame: at 12 months
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
Patient-reported financial worry
Time Frame: At baseline and at 3, 6 and 12 months
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
Patient-reported satisfaction with care at 12 months
Time Frame: At baseline and at 3, 6 and 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
Patient-reported Quality of life - mental and physical health
Time Frame: At baseline and at 3, 6 and 12 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Out of pocket cost (OOPC) accuracy
Time Frame: At 3, 6 and 12 months
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
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.
Time Frame: Up to 12 months
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
Patient reported satisfaction with intervention
Time Frame: 39 months after enrollment of first study participant

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
Receipt of financial navigation via internal practice or external resources
Time Frame: 12 months

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
Evaluate longitudinal changes in Cost-related cancer care non-adherence, material hardship, financial worry, quality of life and satisfaction with care
Time Frame: At baseline and at 3, 6 and 12 months
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
longitudinal changes in cost-related cancer care non-adherence
Time Frame: At baseline, 3, 6 and 12 months

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
longitudinal changes in cost-related cancer care material hardship
Time Frame: At baseline, 3, 6 and 12 months

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
longitudinal changes in cost-related cancer care financial worry
Time Frame: At baseline, 3, 6 and 12 months

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
longitudinal changes in cost-related cancer care quality of life
Time Frame: At baseline, 3, 6 and 12 months

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
longitudinal changes in cost-related cancer care satisfaction with care
Time Frame: At baseline, 3, 6 and 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Gelareh Sadigh, ECOG-ACRIN Cancer Research Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • EAQ222CD (Other Identifier: CTEP)
  • UG1CA189828 (U.S. NIH Grant/Contract)
  • NCI-2023-09944 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • ECOG-ACRIN-EAQ222CD (Other Identifier: DCP)
  • R01CA272680 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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CROs in Tunisia

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