Skip to main content
OpenTrials
Completed

NCT Number: NCT04314284

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gynecologic Cancer Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I Can PIC

Behavioral

-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.

Historical control survey

Other

-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.

Post-intervention survey (I Can PIC participants)

Other

-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.

Follow-Up survey (I Can PIC participants)

Other

-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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2020
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.