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

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04282343
Collaborator
(none)
68
1
2
47.2
1.4

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: The DISCO App
  • Behavioral: Usual Care
N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Double (Care Provider, Outcomes Assessor)
Masking Description:
Trained research assistants and oncologists
Primary Purpose:
Health Services Research
Official Title:
A Phase 2 Trial of the Discussion of Cost (DISCO) App as an Intervention to Improve Financial Outcomes in Hematologic Cancer Patients
Actual Study Start Date :
Feb 25, 2020
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Arm I- Usual care

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 randomized to this arm will receive usual care.

Other: Arm II - DISCO app

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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).

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201

Sponsors and Collaborators

  • Barbara Ann Karmanos Cancer Institute

Investigators

  • Principal Investigator: Lauren Hamel, PhD, Barbara Ann Karmanos Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lauren Hamel, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT04282343
Other Study ID Numbers:
  • 2019-131
First Posted:
Feb 24, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2022