Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

May 8, 2023 updated by: Washington University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Completion of survey (estimated to be approximately 1-14 days after enrollment)]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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
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)
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
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)
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
Change from post-intervention survey to 3-6 month follow-up survey (estimated to be a total of 6 months)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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
Completion of survey (estimated to be approximately 1-14 days after enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mary Politi, Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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