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NCT Number: NCT04282343

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

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

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Key information

Conditions

Chronic Lymphocytic Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Chronic Disease Chronic Myelogenous Leukemia, BCR-ABL1 Positive Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Lymphatic Diseases Lymphoproliferative Disorders Multiple Myeloma Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Plasma Cell Myeloma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Behavioral

Patients randomized to this arm will receive usual care.

Primary outcomes

  1. Presence of cost discussion observed via video recordings of patient-physician treatment discussions.

    Time frame: Observed during the video-recorded patient-physician interaction.

    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.

Secondary outcomes

  1. Referrals for financial or psychological support

    Time frame: Immediately after the patient-physician interaction

    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.

  2. Self-efficacy in managing treatment cost

    Time frame: Immediately after the patient-physician interaction

    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).

  3. Self-efficacy in patient-physician interactions

    Time frame: Immediately after the patient-physician interaction

    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)

  4. Treatment cost distress

    Time frame: Immediately after the patient-physician interaction

    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)

  5. Anticipated material hardship

    Time frame: Immediately after the patient-physician interaction

    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)

  6. Financial toxicity

    Time frame: 3 months after the patient-physician interaction

    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)

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2020
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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