Clinical trial NCT04282343: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Plasma Cell Myeloma
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of cost discussion observed via video recordings of patient-physician treatment discussions.
timeFrame: Observed during the video-recorded patient-physician interaction.
Secondary outcomes:
measure: Referrals for financial or psychological support
timeFrame: Immediately after the patient-physician interaction
measure: Self-efficacy in managing treatment cost
timeFrame: Immediately after the patient-physician interaction
measure: Self-efficacy in patient-physician interactions
timeFrame: Immediately after the patient-physician interaction
measure: Treatment cost distress
timeFrame: Immediately after the patient-physician interaction
measure: Anticipated material hardship
timeFrame: Immediately after the patient-physician interaction
measure: Financial toxicity
timeFrame: 3 months after the patient-physician interaction
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Institute
name: Lauren Hamel, PhD
role: PRINCIPAL_INVESTIGATOR
References: