Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

Colorectal Cancer Clinical Trial

Official title:

Implementing a Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314284
• Other study ID #: 202003033
• Secondary ID: 1P50CA244431-01
• Status: Completed
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: November 4, 2021

Study information

• Verified date: May 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to incorporate feedback from cancer patients and providers to adapt, implement, and test an intervention. The intervention aims to prompt screening for financial distress, facilitate discussions about care costs with cancer patients, support health insurance selection, and ultimately reduce cancer patients' financial toxicity associated with cancer care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 4, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligibility criteria for I Can Pic Arm only:

Inclusion Criteria:

• 18 years of age or older

• Must have been diagnosed with colorectal cancer, lung cancer, or gynecologic cancer < 5 months ago and be patients of one of the 15 providers

• This cancer diagnosis must be the first and primary diagnosis

Exclusion Criteria:

• Not able to read and understand English

• Cannot give informed consent due to cognitive or emotional barriers

Related Conditions & MeSH terms

• Colorectal Cancer
• Financial Stress
• Gynecologic Cancer
• Lung Cancer

Intervention

Behavioral:
• I Can PIC
-Online decision tool that explains health insurance terms and health insurance terms, provides tips on lowering health care costs, advises patient to discuss costs with provider and insurance, and provides financial resources for patient.

Other:
• Historical control survey
-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data.
• Post-intervention survey (I Can PIC participants)
-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data.
• Follow-Up survey (I Can PIC participants)
-19 questions including overall experience with cancer care provider, discussion with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, and confidence in health care choices and health insurance choices.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delayed or Forgone Care Due to Costs (I Can PIC Arm)	Delayed or forgone care due to costs will be collected on the post-intervention survey and the 3-6 month follow-up survey; Score from 0 (best) to 8 (worst). Higher scores indicate more frequent delayed and forgone care due to costs	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Other	Delayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)	Delayed or forgone care due to costs will be collected on the historical control survey and the I Can PIC post-intervention survey; Score from 0 (best) to 8 (worst). Higher scores indicate more frequent delayed and forgone care due to costs	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm	Health insurance knowledge will be collected on the historical control survey and the I Can PIC post-intervention survey; Score from 0% (worst) to 100% (best). Higher scores indicate greater health insurance knowledge	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm	Health insurance literacy will be collected on the historical control survey and the I Can PIC post-intervention survey; Score from 12 (worst) to 48 (best). Higher scores indicate greater health insurance literacy	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm	Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey; Score either no (did not discuss health care costs with clinician) or yes (discussed one more cost-related topics with clinicians); Also score the number of cost-related topics discussed, if yes	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm	-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm	-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm	-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm	Confidence communicating about health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey; Score from 4 (worst) to 16 (best). Higher scores indicate greater confidence communicating about care costs	Completion of survey (estimated to be approximately 1-14 days after enrollment)
Primary	Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm	Financial toxicity will be collected on the historical control survey and the I Can PIC post-intervention survey; Score from 0 (best) to 44 (worst). Higher scores indicate greater financial toxicity	Completion of survey (estimated to be Day 1 for historical control participants and estimated to be Day 14 for I Can PIC participants)
Primary	Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs	Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey; Score either no (did not refer to resources) or yes (referred to resources); Also score the number of cost-related topics discussed, if yes	Completion of survey (estimated to be approximately 1-14 days after enrollment)]
Secondary	Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)	Sustained Health insurance knowledge will be collected on the post-intervention survey and the 3-6 month follow-up survey; Score from 0% (worst) to 100% (best). Higher scores indicate greater health insurance knowledge	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Secondary	Health Insurance Literacy Sustained Over Time (I Can PIC Arm)	Sustained Health insurance literacy will be collected on the post-intervention survey and the 3-6 month follow-up survey; Score from 12 (worst) to 48 (best). Higher scores indicate greater health insurance literacy	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Secondary	Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)	Confidence communicating about health care costs will be collected on the post-intervention survey and the 3-6 month follow-up survey; Score from 4 (worst) to 16 (best). Higher scores indicate greater confidence communicating about care costs	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Secondary	Sustained Financial Toxicity (I Can PIC Arm)	Sustained Financial toxicity will be collected on the post-intervention survey and the 3-6 month follow-up survey; Score from 0 (best) to 44 (worst). Higher scores indicate greater financial toxicity	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine