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

NCT04282343 | Completed

• 1 other identifier: 2019-131
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Referrals for financial or psychological support

  Immediately after the patient-physician interaction

• Self-efficacy in managing treatment cost

  Immediately after the patient-physician interaction

• Self-efficacy in patient-physician interactions

  Immediately after the patient-physician interaction

• Treatment cost distress

  Immediately after the patient-physician interaction

• Anticipated material hardship

  Immediately after the patient-physician interaction

Study Arms (2)

Arm I- Usual care

OTHER

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

Arm II - DISCO app

OTHER

Patients use the DISCO education and communication app before attending video-recorded meetings with their oncologist to discuss treatment plans.

Behavioral: The DISCO App

Interventions

The DISCO App BEHAVIORAL

Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist.

Arm II - DISCO app

Usual Care BEHAVIORAL

Patients randomized to this arm will receive usual care.

Arm I- Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Multiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Lauren Hamel, PhD

  Barbara Ann Karmanos Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Trained research assistants and oncologists
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients are randomized to 1 of 2 arms: ARM I: 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 plan; or ARM II: Patients use the DISCO education and communication app before attending video-recorded meetings with their oncologist to discuss treatment plans. After completion of study, patients are followed up at 3 months.

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 24, 2020
• Study Start: February 25, 2020
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)