Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity

NCT04314284 | Completed Results

• 2 other identifiers: 2020030331P50CA244431-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Colorectal Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (9)

• 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

  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

  * 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

  * 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

  -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

  -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

  -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

  * 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

  * 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

  * 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 Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (2)

• Delayed or Forgone Care Due to Costs (I Can PIC Arm)

  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)

  Completion of survey (estimated to be approximately 1-14 days after enrollment)

Study Arms (2)

Historical Control Survey

OTHER

-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

I Can PIC

EXPERIMENTAL

-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; Other: Post-intervention survey (I Can PIC participants); Other: Follow-Up survey (I Can PIC participants)

Interventions

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.

I Can PIC

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.

Historical Control Survey

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.

I Can PIC

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.

I Can PIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mary Politi, Ph.D.
• Organization: Washington University School of Medicine

mpoliti@wustl.edu

314-747-1967

Study Officials

• Mary Politi, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 19, 2020
• Study Start: May 26, 2020
• Primary Completion: August 27, 2021
• Study Completion: November 4, 2021
• Last Updated: May 9, 2023
• Results First Posted: June 13, 2022

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)