Feasibility and Utilization of an Application-based Question Prompt List
Primary Purpose
Financial Toxicity, Cancer, Question Prompt List
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discussions of Cost App (DISCO App)
Sponsored by
About this trial
This is an interventional treatment trial for Financial Toxicity focused on measuring financial toxicity, cancer, treatment cost, patient-provider communication
Eligibility Criteria
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
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Arm
Arm Description
This feasibility study includes only one arm. All enrolled patients will be asked to use the intervention.
Outcomes
Primary Outcome Measures
Patient-oncologist treatment cost discussions
Observational measures using video-recorded patient-oncologist treatment discussions
Patient-oncologist treatment cost discussions
Self-report measures of if and how patients and oncologists discuss treatment cost.
Secondary Outcome Measures
Patient financial demographics
Patient financial situation (e.g., income, perceived economic burden, etc.)
Change in patient treatment cost information desired and gained
What cost treatment information patients want before the interaction and if they gained it during the interaction with their 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.
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.
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.
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.
Length of the interaction
Observer measure of the length of the patient-oncologist collected using video recordings.
DISCO App use (observer measure)
Observer measure of how patients use the DISCO App collected using video recordings
Full Information
NCT ID
NCT03676920
First Posted
September 12, 2018
Last Updated
October 1, 2020
Sponsor
Barbara Ann Karmanos Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03676920
Brief Title
Feasibility and Utilization of an Application-based Question Prompt List
Official Title
Improving Treatment Cost Discussions Between Cancer Patients and Their Oncologists: Feasibility and Utilization of an Application-based Question Prompt List
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 21, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Financial Toxicity, Cancer, Question Prompt List
Keywords
financial toxicity, cancer, treatment cost, patient-provider communication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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, and associated measures.
Masking
None (Open Label)
Masking Description
There is only one arm and patients will know they are testing the intervention. Physicians will not be told explicitly which of their patients are enrolled in the study but they may see patients with the intervention (either on an iPad or in a printed version).
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
This feasibility study includes only one arm. All enrolled patients will be asked to use the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Discussions of Cost App (DISCO App)
Other Intervention Name(s)
DISCO App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-oncologist treatment cost discussions
Description
Observational measures using video-recorded patient-oncologist treatment discussions
Time Frame
During the treatment discussions and observed via video recordings of those discussions.
Title
Patient-oncologist treatment cost discussions
Description
Self-report measures of if and how patients and oncologists discuss treatment cost.
Time Frame
Collected immediately after the interaction with the oncologist
Secondary Outcome Measure Information:
Title
Patient financial demographics
Description
Patient financial situation (e.g., income, perceived economic burden, etc.)
Time Frame
Collected immediately prior to the interaction with the oncologist
Title
Change in patient treatment cost information desired and gained
Description
What cost treatment information patients want before the interaction and if they gained it during the interaction with their oncologist.
Time Frame
Collected immediately prior to and immediately after the interaction with the oncologist
Title
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.
Description
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.
Time Frame
Collected immediately prior to and immediately after the interaction with the oncologist
Title
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.
Description
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.
Time Frame
Collected immediately after the interaction with the oncologist
Title
Length of the interaction
Description
Observer measure of the length of the patient-oncologist collected using video recordings.
Time Frame
During the patient-oncologist interaction and observed via video recordings of the treatment discussions
Title
DISCO App use (observer measure)
Description
Observer measure of how patients use the DISCO App collected using video recordings
Time Frame
Prior to and during the patient-oncologist interaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Hamel, Ph.D.
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
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Feasibility and Utilization of an Application-based Question Prompt List
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