Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Plasma Cell Myeloma
Conditions
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.
Interventions
BEHAVIORALThe 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.
BEHAVIORALUsual Care
Patients randomized to this arm will receive usual care.
Sponsors
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Trained research assistants and oncologists
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of cost discussion observed via video recordings of patient-physician treatment discussions. | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy in managing treatment cost | 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). |
| Self-efficacy in patient-physician interactions | 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) |
| Referrals for financial or psychological support | 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. |
| Anticipated material hardship | 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) |
| Financial toxicity | 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) |
| Treatment cost distress | 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) |
Countries
United States
Outcome results
None listed