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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03676920
Other study ID # 2017-129
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 21, 2018
Est. completion date December 31, 2019

Study information

Verified date April 2024
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Discussions of Cost App (DISCO App)
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.

Locations

Country Name City State
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Barbara Ann Karmanos Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient-oncologist treatment cost discussions Observational measures using video-recorded patient-oncologist treatment discussions During the treatment discussions and observed via video recordings of those discussions.
Primary Patient-oncologist treatment cost discussions Self-report measures of if and how patients and oncologists discuss treatment cost. Collected immediately after the interaction with the oncologist
Secondary Patient financial demographics Patient financial situation (e.g., income, perceived economic burden, etc.) Collected immediately prior to the interaction with the oncologist
Secondary 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. Collected immediately prior to and immediately after the interaction with the oncologist
Secondary 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. Collected immediately prior to and immediately after the interaction with the oncologist
Secondary 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. Collected immediately after the interaction with the oncologist
Secondary Length of the interaction 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
Secondary DISCO App use (observer measure) 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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