- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03676920
Feasibility and Utilization of an Application-based Question Prompt List
April 17, 2024 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
This trial studies how well an application-based question prompt list works in improving treatment cost discussion between patients with breast, prostate, lung, or colorectal cancer and their oncologists.
An application-based question prompt list, called Discussion of Cost Application (DISCO App), may help to improve how patients and oncologists discuss cancer treatment costs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 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
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-
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
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: Other
- 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:
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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
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During the treatment discussions and observed via video recordings of those discussions.
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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
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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
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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.
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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
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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)
April 18, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-129
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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