Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

• ClinicalTrials.gov Identifier: NCT04314284
• Recruitment Status: Completed
• First Posted: March 19, 2020
• Results First Posted: June 13, 2022
• Last Update Posted: August 1, 2022
• Sponsor: Washington University School of Medicine
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Washington University School of Medicine

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.

Condition or disease	Intervention/treatment	Phase
Gynecologic Cancer; Colorectal Cancer; Lung Cancer	Behavioral: I Can PIC; Other: Historical control survey; Other: Post-intervention survey (I Can PIC participants); Other: Follow-Up survey (I Can PIC participants)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementing a Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity
• Actual Study Start Date: May 26, 2020
• Actual Primary Completion Date: August 27, 2021
• Actual Study Completion Date: November 4, 2021

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Difference in Health Insurance Knowledge Between Historical Control Arm and I Can PIC Arm [ Time Frame: 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
2. Difference in Health Insurance Literacy Between Historical Control Arm and I Can PIC Arm [ Time Frame: 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
3. Difference in the Number of Clinicians That Discussed Health Care Cost Topics With Participants Between the Historical Control Arm and I Can PIC Arm [ Time Frame: 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
4. Difference in the Number of Cost-related Topics Discussed With Participants Between the Historical Control Arm and I Can PIC Arm [ Time Frame: 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
5. Difference in the Number of Clinicians That Discussed Health Care Cost Strategies Between the Historical Control Arm and I Can PIC Arm [ Time Frame: 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
6. Difference in the Number of Cost Strategies Discussed Between the Historical Control Arm and I Can PIC Arm [ Time Frame: 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
7. Difference in Confidence Communicating About Health Care Costs With Physician Between Historical Control Arm and I Can PIC Arm [ Time Frame: 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
8. Difference in Financial Toxicity Between Historical Control Arm and I Can PIC Arm [ 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) ]
   • 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
9. Difference in Number of Clinicians Who Referred Patients to Resources to Discuss Costs [ Time Frame: 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

Secondary Outcome Measures :

1. Health Insurance Knowledge Sustained Over Time (I Can PIC Arm) [ Time Frame: 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
2. Health Insurance Literacy Sustained Over Time (I Can PIC Arm) [ Time Frame: 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
3. Confidence Communicating About Health Care Costs With Physician (I Can PIC Arm) [ Time Frame: 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
4. Sustained Financial Toxicity (I Can PIC Arm) [ Time Frame: 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

Other Outcome Measures:

1. Delayed or Forgone Care Due to Costs (I Can PIC Arm) [ Time Frame: 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 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
2. Delayed or Forgone Care Due to Costs (Historical Control Arm and I Can PIC Arm) [ Time Frame: Completion of survey (estimated to be approximately 1-14 days after enrollment) ]
   • 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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mary Politi, Ph.D.; Washington University School of Medicine

  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

Study Protocol and Statistical Analysis Plan  [PDF] September 7, 2021

Informed Consent Form  [PDF] October 27, 2020

More Information

Additional Information:

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

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04314284
• Other Study ID Numbers: 202003033; 1P50CA244431-01 ( U.S. NIH Grant/Contract )
• First Posted: March 19, 2020
• Results First Posted: June 13, 2022
• Last Update Posted: August 1, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Financial Stress; Stress, Psychological; Behavioral Symptoms