Clinical trial NCT04314284: Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity
Official title: Implementing a Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Colorectal Cancer
Lung Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
measure: Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
measure: Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
measure: Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
measure: Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
measure: Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
measure: Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
measure: Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm
timeFrame: Completion of survey (estimated to be Day 1 for historical control participants and estimated to be Day 14 for I Can PIC participants)
measure: Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)]
Secondary outcomes:
measure: Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)
timeFrame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
measure: Health Insurance Literacy Sustained Over Time (I Can PIC Arm)
timeFrame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
measure: Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)
timeFrame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
measure: Sustained Financial Toxicity (I Can PIC Arm)
timeFrame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Other outcomes:
measure: Delayed or Forgone Care Due to Costs (I Can PIC Arm)
timeFrame: Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
measure: Delayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)
timeFrame: Completion of survey (estimated to be approximately 1-14 days after enrollment)
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary Politi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: