Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

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

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Colorectal Cancer; Lung Cancer
• Intervention / Treatment: Other: Historical control survey; Behavioral: I Can PIC; Other: Post-intervention survey (I Can PIC participants); Other: Follow-Up survey (I Can PIC participants)

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Historical Control Survey; -The investigators will conduct a historic control survey of 80-100 recently diagnosed gynecologic, colorectal, and lung cancer patients. They can complete the survey in-person, over the phone, or online. The survey will take approximately 15 minutes to complete. It will ask about their knowledge of health insurance and confidence communicating about care costs.	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.
Experimental: I Can PIC; -Approximately 80-100 participants will use I Can PIC. This will take approximately 10-15 minutes. After their next appointment with their provider, they will complete a brief survey about their knowledge of health insurance and confidence communicating about care costs. This will take about 10 mins. Patient participants who choose to complete the study in person may view I Can PIC on a tablet provided in the clinic or at the office. Then after their appointment, they can complete the survey on a tablet provided in the clinic or at the office. If they choose to complete it over the phone, the investigators will email them the link to I Can PIC and then call them when it is time to complete the survey. If they wish to complete it online, the investigators will email them the link to I Can PIC, and then the survey after their appointment. After 3-6 months, participants will receive a 5-10 minute follow-up survey which they can complete in-person, online, or over the phone.	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: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mary Politi, Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Actual): August 27, 2021
• Study Completion (Actual): November 4, 2021

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress
• Other Study ID Numbers: 202003033; 1P50CA244431-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No