Feasibility and Utilization of an Application-based Question Prompt List

October 1, 2020 updated by: Lauren Hamel, Barbara Ann Karmanos Cancer Institute

Improving Treatment Cost Discussions Between Cancer Patients and Their Oncologists: Feasibility and Utilization of an Application-based Question Prompt List

The overall goal of this research is to reduce financial toxicity related to the cost of cancer treatment in a diverse patient population. The research tests the feasibility of an application-based ("app") communication intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions during clinical interactions, which, in turn, should improve other short- and longer-term patient outcomes, including referrals to economic support (e.g., social work); efficacy in managing treatment cost; treatment cost distress; financial toxicity; and treatment adherence. If successful, this study will result in an evidence-based tool that can reduce financial toxicity and improve medical outcomes for a diverse patient population.

Study Overview

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • 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

    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical oncologists or radiation oncologists at KCI McLaren Detroit, McLaren Flint, McLaren Macomb and McLaren Port Huron oncology centers
  • Oncologists will be eligible if they treat patients with prostate, breast, lung or colorectal cancers.
  • Oncologists will be consented
  • Patients must be 18 yrs. old or older
  • Patients will be consented
  • Patients must be able to read and write in English
  • Patients must have a confirmed diagnosis of breast, prostate, lung or colorectal cancer and are scheduled to see an oncologist for an initial treatment discussion.

Exclusion Criteria:

  • N/A

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
This feasibility study includes only one arm. All enrolled patients will be asked to use the intervention.
The DISCO App is an app-based and patient-focused intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions. The DISCO App allows patients to provide basic demographic information (e.g., employment status, insurance status, etc), and uses that information to provide patients with an individually-tailored list of treatment cost questions they can ask their provider.
Other Names:
  • DISCO App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oncologist treatment cost discussions
Time Frame: During the treatment discussions and observed via video recordings of those discussions.
Observational measures using video-recorded patient-oncologist treatment discussions
During the treatment discussions and observed via video recordings of those discussions.
Patient-oncologist treatment cost discussions
Time Frame: Collected immediately after the interaction with the oncologist
Self-report measures of if and how patients and oncologists discuss treatment cost.
Collected immediately after the interaction with the oncologist

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient financial demographics
Time Frame: Collected immediately prior to the interaction with the oncologist
Patient financial situation (e.g., income, perceived economic burden, etc.)
Collected immediately prior to the interaction with the oncologist
Change in patient treatment cost information desired and gained
Time Frame: Collected immediately prior to and immediately after the interaction with the oncologist
What cost treatment information patients want before the interaction and if they gained it during the interaction with their oncologist.
Collected immediately prior to and immediately after the interaction with the oncologist
Change in patient efficacy in managing treatment cost (10-item scale). This measure will assess any change in the patients' efficacy in paying for the cost of their cancer treatment before and after the intervention.
Time Frame: Collected immediately prior to and immediately after the interaction with the oncologist
If patients think they will be able to pay for the cost of their cancer treatment. This is adapted from a validated 10-item scale (Peterson AM, Harper FW, Albrecht TL, et al. Parent caregiver self-efficacy and child reactions to pediatric cancer treatment procedures. J Pediatr Oncol Nurs. 2014;31(1):18-27.) An example item is: "I am confident I can pay for the costs of my treatment." Patients will respond to a scale from Strongly Disagree (1) to Strongly Agree (5) with higher values representing a better outcome.
Collected immediately prior to and immediately after the interaction with the oncologist
Satisfaction with treatment cost discussions (3-item scale). This will assess the extent to which patients are satisfied with any discussions of treatment cost they had with their oncologist.
Time Frame: Collected immediately after the interaction with the oncologist
The extent to which patients are satisfied with any treatment cost discussion they had with their oncologist. This is an investigator-developed 3-item scale. An example item is: "I am satisfied with how my oncologist and I discussed treatment cost today." Patients will respond to a scale from Strongly Disagree (1) to Strongly Agree (5) with higher values representing a better outcome.
Collected immediately after the interaction with the oncologist
Length of the interaction
Time Frame: During the patient-oncologist interaction and observed via video recordings of the treatment discussions
Observer measure of the length of the patient-oncologist collected using video recordings.
During the patient-oncologist interaction and observed via video recordings of the treatment discussions
DISCO App use (observer measure)
Time Frame: Prior to and during the patient-oncologist interaction
Observer measure of how patients use the DISCO App collected using video recordings
Prior to and during the patient-oncologist interaction

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Lauren Hamel, Ph.D., Barbara Ann Karmanos Cancer Institute

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)

August 21, 2018

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

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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