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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Lymphocytic Leukemia; Plasma Cell Myeloma; Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: The DISCO App

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Hamel, PhD; Phone Number: (313) 576-9672; Email: hamell@karmanos.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm I- Usual care; Patients receive usual care consisting of general cancer treatment information on a sheet of paper before attending video-recorded meetings with their oncologist to discuss treatment plans.	Behavioral: Usual Care; Patients randomized to this arm will receive usual care.
Other: Arm II - DISCO app; Patients use the DISCO education and communication app before attending video-recorded meetings with their oncologist to discuss treatment plans.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute
• Investigators: Principal Investigator: Lauren Hamel, PhD, Barbara Ann Karmanos Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2020
• Primary Completion (Actual): October 21, 2022
• Study Completion (Actual): October 21, 2022

Study Registration Dates

• First Submitted: February 9, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Leukemia, Lymphoid; Leukemia, B-Cell; Hematologic Neoplasms; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: 2019-131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No