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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

The DISCO App

Usual Care

About this trial

This is an interventional health services research trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Arm I- Usual care

Arm II - DISCO app

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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)

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)

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)

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)

Full Information

NCT ID

NCT04282343

First Posted

February 9, 2020

Last Updated

May 1, 2023

Sponsor

Barbara Ann Karmanos Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04282343

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 25, 2020 (Actual)

Primary Completion Date

October 21, 2022 (Actual)

Study Completion Date

October 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Barbara Ann Karmanos Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

Care ProviderOutcomes Assessor

Masking Description

Trained research assistants and oncologists

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I- Usual care

Arm Type

Other

Arm Description

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.

Arm Title

Arm II - DISCO app

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

The DISCO App

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Usual Care

Intervention Description

Patients randomized to this arm will receive usual care.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Observed during the video-recorded patient-physician interaction.

Secondary Outcome Measure Information:

Title

Referrals for financial or psychological support

Description

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.

Time Frame