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Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

Primary Purpose

Gynecologic Cancer, Colorectal Cancer, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I Can PIC
Historical control survey
Post-intervention survey (I Can PIC participants)
Follow-Up survey (I Can PIC participants)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gynecologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Historical Control Survey

I Can PIC

Arm Description

-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.

-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.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
March 16, 2020
Last Updated
May 8, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04314284
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Colorectal Cancer, Lung Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Historical Control Survey
Arm Type
Other
Arm Description
-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.
Arm Title
I Can PIC
Arm Type
Experimental
Arm Description
-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.
Intervention Type
Behavioral
Intervention Name(s)
I Can PIC
Intervention Description
-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.
Intervention Type
Other
Intervention Name(s)
Historical control survey
Intervention Description
-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.
Intervention Type
Other
Intervention Name(s)
Post-intervention survey (I Can PIC participants)
Intervention Description
-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.
Intervention Type
Other
Intervention Name(s)
Follow-Up survey (I Can PIC participants)
Intervention Description
-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.
Primary Outcome Measure Information:
Title
Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm
Description
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
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Title
Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm
Description
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
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Title
Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm
Description
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
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Title
Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm
Description
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Title
Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm
Description
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Title
Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm
Description
-Information regarding clinicians who discussed health care costs will be collected on the historical control survey and the I Can PIC post-intervention survey
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Title
Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm
Description
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
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)
Title
Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm
Description
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
Time Frame
Completion of survey (estimated to be Day 1 for historical control participants and estimated to be Day 14 for I Can PIC participants)
Title
Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs
Description
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
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)]
Secondary Outcome Measure Information:
Title
Health Insurance Knowledge Sustained Over Time (I Can PIC Arm)
Description
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
Time Frame
Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Title
Health Insurance Literacy Sustained Over Time (I Can PIC Arm)
Description
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
Time Frame
Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Title
Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm)
Description
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
Time Frame
Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Title
Sustained Financial Toxicity (I Can PIC Arm)
Description
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
Time Frame
Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Other Pre-specified Outcome Measures:
Title
Delayed or Forgone Care Due to Costs (I Can PIC Arm)
Description
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
Time Frame
Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)
Title
Delayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm)
Description
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
Time Frame
Completion of survey (estimated to be approximately 1-14 days after enrollment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Politi, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

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