DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer

NCT ID: NCT04766190

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-10

Study Completion Date

2028-08-31

Brief Summary

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The DISCO App is designed to improve, during the interaction, patient active participation and patient-initiated oncologist treatment cost discussions, and, in the short term, patient's treatment cost knowledge, self-efficacy for managing both cost and physician interactions, referrals, perceived financial toxicity (i.e., distress and material hardship); in turn, these will affect longer-term outcomes of financial toxicity and adherence.

Detailed Description

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This work is based on the core scientific premise - that increasing patient active participation and the frequency and quality of treatment cost discussions will decrease the short- and longer-term burdens of financial toxicity through their influence on self-efficacy for managing treatment cost. The focus is on patient self-efficacy for managing treatment cost because it is expected that improved treatment cost education and patient-oncologist treatment cost discussions prompted by the DISCO App will directly improve the self-efficacy needed for patients to proactively manage treatment costs, thus reducing the material and psychological burden of financial toxicity. The DISCO App is not designed to increase patients' ability to pay or reduce the cost of treatment, but it may benefit patients by increasing: their knowledge of treatment costs, their self-efficacy for managing cost, and the likelihood they receive financial and psychological assistance and support. This research is significant because, if successful, reducing the material and psychological burden of financial toxicity will improve the quality of care and work toward achieving health equity. The DISCO App has already been tested for its feasibility and acceptability. The DISCO App will now be tested for its effectiveness in a diverse population of people with solid tumors treated with IV and oral chemotherapies.

Conditions

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Financial Toxicity Cancer Question Prompt List Breast Cancer Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The research tests the effectiveness of an application-based ("app") communication intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions during clinical interactions, and associated measures.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group 1: Usual Care

The patient will be asked to arrive 30 minutes early to their next scheduled appointment with their oncologist so they can complete a survey.

The patient will be video recorded at their appointment. The oncologist has agreed to be video recorded. Immediately after this appointment, the patient will be asked to complete another brief survey that takes about 20 minutes. The questions will ask about how the meeting went. The patient's meeting with the oncologist will not be delayed or changed in any way because of this study.

Group Type OTHER

Group 1: Usual Care

Intervention Type BEHAVIORAL

Patients randomized to this arm will receive usual care.

Group 2: The DISCO App

The patient will be asked to arrive 30 minutes early to their next scheduled appointment with their oncologist so they can complete a survey.

The patient will be shown an iPad with an "app" while waiting to see their oncologist. The app includes a short video and asks questions about the patient's financial concerns. The app will give the patient a list of questions the patient may want to ask their oncologist during their appointment. The patient will then meet with their oncologist. The meeting with the patient's oncologist will be video recorded. The oncologist has agreed to be video recorded. Immediately after meeting the oncologist, the patient will complete another brief survey. The questions will ask about how the meeting went and what the patient thought of the app. The meeting with the oncologist will not be delayed or changed in any way because of this study.

Group Type OTHER

Group 2: The DISCO App

Intervention Type BEHAVIORAL

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

Group 3: The DISCO App + Booster

The patient will be asked to arrive 30 minutes early to their next scheduled appointment with their oncologist so they can complete a survey.

The patient will be shown an iPad with an "app" while waiting to see your oncologist. The app includes a short video and asks questions about your financial concerns. The app will give the patient a list of questions they may want to ask their oncologist during their appointment. The patient will then meet with their oncologist. The meeting with their oncologist will be video recorded. The oncologist has agreed to be video recorded. Immediately after meeting their oncologist, they will complete another brief survey. The questions will ask about how the meeting went and what they thought of the app. The patient's meeting with the oncologist will not be delayed or changed in any way because of this study. Two months after that appointment, the patient will be sent a reminder of the information that was presented on the app.

Group Type OTHER

Group 3: The DISCO App + Booster

Intervention Type BEHAVIORAL

Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist. Then, 2 months later they will receive an intervention booster in the form of an individually-tailored email to remind patients of the contents of the intervention.

Interventions

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Group 2: 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.

Intervention Type BEHAVIORAL

Group 1: Usual Care

Patients randomized to this arm will receive usual care.

Intervention Type BEHAVIORAL

Group 3: The DISCO App + Booster

Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist. Then, 2 months later they will receive an intervention booster in the form of an individually-tailored email to remind patients of the contents of the intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Oncologists are eligible if they treat patients with breast, prostate, lung, or colorectal cancers at Karmanos Cancer Institute. Data from oncologists will include their self-report data and video-recorded treatment discussions with participating patients.
* Patients: Must be able to read and write in English; have an email account; and are newly diagnosed with breast, prostate, lung or colorectal cancer (stage I-IV) for which systemic therapy is a likely recommended treatment. Data from patients will include their self-report data, video-recorded treatment discussions with participating oncologists, and medical record data

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lauren Hamel

OTHER

Sponsor Role lead

Responsible Party

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Lauren Hamel

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lauren Hamel, PhD

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Insitute

Locations

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Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren Hamel, PhD

Role: CONTACT

313-576-9672

Facility Contacts

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Lauren Hamel, PhD

Role: primary

313-576-9672

References

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Hamel LM, Dougherty DW, Kim S, Heath EI, Mabunda L, Tadesse E, Hill R, Eggly S. DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population. Trials. 2021 Sep 17;22(1):636. doi: 10.1186/s13063-021-05593-y.

Reference Type DERIVED
PMID: 34535162 (View on PubMed)

Other Identifiers

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RSG-20-026-01 - CPHPS

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2020-117

Identifier Type: -

Identifier Source: org_study_id

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