An interventional study of The DISCO App and Usual Care in Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive and Plasma Cell Myeloma, sponsored by Barbara Ann Karmanos Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Barbara Ann Karmanos Cancer Institute · Not applicable, Interventional, and Health services research
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
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.
1,648 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 245 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 1,356 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 160 studies on the registry; 18 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Patients use the DISCO education and communication app before attending video-recorded meetings with their oncologist to discuss treatment plans.
Behavioral: The 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.
Patients randomized to this arm will receive usual care.
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.
Time frame: Observed during the video-recorded patient-physician interaction.
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.
Time frame: Immediately after the patient-physician interaction
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).
Time frame: Immediately after the patient-physician interaction
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)
Time frame: Immediately after the patient-physician interaction
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)
Time frame: Immediately after the patient-physician interaction
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)
Time frame: Immediately after the patient-physician interaction
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)
Time frame: 3 months after the patient-physician interaction
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2020 to primary completion in Oct 2022, 31 months.
Of 38 interventional studies with no phase under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 128. This study's 31 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Leukemia, Lymphocytic, Chronic, B-Cell →
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