Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

Not Applicable

Completed

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

• Registration Number: NCT04314284
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-19
• Study Start: 2020-05-26
• Primary Completion: 2021-08-27
• Study Completion: 2021-11-04
• Results First Submitted: 2022-04-20
• Results First Submitted QC: 2022-05-18
• Results First Posted: 2022-06-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

• Not able to read and understand English
• Cannot give informed consent due to cognitive or emotional barriers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I Can PIC	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.
Historical Control Survey	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.
I Can PIC	Post-intervention survey (I Can PIC participants)	-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.
I Can PIC	Follow-Up survey (I Can PIC participants)	-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.

Primary Outcome Measures

Name	Time	Method
Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be approximately 1-14 days after enrollment)	* 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
Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be approximately 1-14 days after enrollment)	* 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
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be approximately 1-14 days after enrollment)	-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs	Completion of survey (estimated to be approximately 1-14 days after enrollment)]	* 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
Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be approximately 1-14 days after enrollment)	-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be Day 1 for historical control participants and estimated to be Day 14 for I Can PIC participants)	* 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
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be approximately 1-14 days after enrollment)	-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be approximately 1-14 days after enrollment)	* 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
Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm	Completion of survey (estimated to be approximately 1-14 days after enrollment)	* 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

Secondary Outcome Measures

Name	Time	Method
Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)	* 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
Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)	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 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
Health Insurance Literacy Sustained Over Time (I Can PIC Arm)	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)	* 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
Sustained Financial Toxicity (I Can PIC Arm)	Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)	* 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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States