DISCO Application for the Improvement of Financial Outcomes in Patients With Hematologic Cancer

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase 2 Trial of the Discussion of Cost (DISCO) App as an Intervention to Improve Financial Outcomes in Hematologic Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04282343
• Other study ID #: 2019-131
• Status: Completed
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: October 21, 2022

Study information

• Verified date: May 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies how well the DIScussion of COst (DISCO) application (app) works in improving financial outcomes in patients with hematologic cancer. The DISCO app is an electronic, highly scalable and tailorable education and communication intervention that may help researchers learn more about improving how patients and oncologists discuss cancer treatment costs

Description:

PRIMARY OBJECTIVE: I. To assess the effectiveness of the DISCO app on prompting patient-oncologist treatment cost discussions during patient-physician interactions (as observed in video recordings), patient outcomes related to financial toxicity immediately after the patient-oncologist interaction, and at a 3-month follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ONCOLOGISTS: Eligible if they treat patients with chronic lymphocytic leukemia (CLL), chronic myelogenous leukemia (CML), or multiple myeloma (MM) cancers
• PATIENTS: Able to read and write in English
• PATIENTS: Have a confirmed diagnosis of CLL, CML, or MM cancers
• PATIENTS: Are scheduled to see an oncologist at Karmanos Cancer Institute (KCI) Detroit or KCI Farmington Hills/Weisberg for an initial or change in treatment discussion

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Hematologic Neoplasms
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Multiple Myeloma
• Plasma Cell Myeloma

Intervention

Behavioral:
• The DISCO App
Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist.
• Usual Care
Patients randomized to this arm will receive usual care.

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	Presence of cost discussion observed via video recordings of patient-physician treatment discussions.	Number of participates who have a treatment cost discussion will be evaluated with a validated observational scale. This is an investigator-developed scale and its called the Discussion of Cost (DISCO) scale. A higher score means a better outcome.	Observed during the video-recorded patient-physician interaction.
Secondary	Referrals for financial or psychological support	Number of participants who receive a referral for financial or psychological support will be evaluated with a self-report item. This an investigator-developed yes/no one-item response. A "yes" response is a better outcome than a "no" response.	Immediately after the patient-physician interaction
Secondary	Self-efficacy in managing treatment cost	How efficacious each participant feels about managing treatment costs will be evaluated with an adapted validated self-report scale and its title is: Managing Treatment Cost Self-Efficacy scale. This an investigator-adapted scale, and a higher score means a better outcome (max =7; min = 1).	Immediately after the patient-physician interaction
Secondary	Self-efficacy in patient-physician interactions	How efficacious each participant feels about interacting with physicians will be evaluated with a validated self-report scale, and its title is: Perceived efficacy in patient-physician interactions (PEPPI). A higher score means a better outcome.(max =50; min = 10)	Immediately after the patient-physician interaction
Secondary	Treatment cost distress	How distress each participant feels about how much their treatment will cost them will be evaluated with an investigator-developed validated self-report scale, and its title is: Treatment Cost Distress Scale. A higher score means a worse outcome. (max =7; min = 1)	Immediately after the patient-physician interaction
Secondary	Anticipated material hardship	How much anticipated material hardship each participant feels they may experienced due to treatment costs will be evaluated with a validated self-report scale, and its title is: Economic Hardship Scale. A higher score means a worse outcome. (max =7; min = 1)	Immediately after the patient-physician interaction
Secondary	Financial toxicity	How much material and psychological hardship the patients experiences due to treatment cost will be evaluated with a validated self-report scale, and its title is: Comprehensive Score for Financial Toxicity (COST). A higher score means a worse outcomes. (max=7; min=1)	3 months after the patient-physician interaction