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

Breast Cancer Clinical Trial

— DISCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04766190
• Other study ID #: 2020-117
• Secondary ID: RSG-20-026-01 -
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: Lauren Hamel, PhD
• Phone: 313-576-9672
• Email: hamell[@]karmanos.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Breast Cancer
• Cancer
• Financial Stress
• Financial Toxicity
• Prostate Cancer
• Question Prompt List

Intervention

Behavioral:
• 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.
• Group 1: Usual Care
Patients randomized to this arm will receive usual care.
• 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.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Lauren Hamel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of the intervention.	Patient perceptions of the intervention's usefulness using an original scale.; An example item from the original measure: The DISCO App helped me ask my doctor my cost questions. Minimum = 1; Maximum = 5; higher is a better outcome.	Immediately after video-recorded patient-physician interaction
Other	Assessment of the intervention booster An example item from the original measure: The reminder email or text message was helpful with my cost questions and concerns.	Patient perceptions of the intervention booster's usefulness	1 month after the video-recorded patient-physician interaction
Other	Intervention presence in video-recorded patient-physician interaction	If the interaction is visible in the video-recorded patient-physician interaction	During the video-recorded patient-physician interaction
Primary	Self-efficacy in patient-physician interactions. An example item from the PEPPI scale: How confident are you in your ability to know what questions to ask your doctor? Data will be aggregated using means and standard deviations.	How efficacious patients feel about communicating with physicians. Scale title: Self-efficacy in patient-physician interactions. Minimum = 1; Maximum = 5; higher is a better outcome.	Immediately after the video-recorded patient-physician interaction
Primary	Self-efficacy in managing treatment costs An example item from adapted scale: I am confident I can pay for the direct costs of my treatment. Data will be aggregated using means and standard deviations.	How efficacious patients feel about managing their treatment costs. Scale title: Self-efficacy in managing treatment costs. Minimum = 1; Maximum = 5; higher is a better outcome.	Immediately after video-recorded patient-physician interaction
Primary	Knowledge of types of treatment cost An example item from the original measure: Cancer treatment may cost me in the following ways? Data will be aggregated using frequency counts.	If patients know the types of cost associated with cancer treatment	Immediately after video-recorded patient-physician interaction
Primary	Perceived financial toxicity; Scale title: Adapted Comprehensive score for financial toxicity (COST) measure.	Anticipated financial harm due to treatment cost. Scale title: Adapted Comprehensive score for financial toxicity (COST) measure. Minimum = 0; Maximum = 4; lower is a better outcome.	Immediately after video-recorded patient-physician interaction
Primary	Perceived presence of treatment cost discussion	Patient perception that treatment cost discussed with the physician	Immediately after video-recorded patient-physician interaction
Primary	Patient self-report of level of satisfaction with any treatment cost discussions with physician assessed via an original scale: satisfaction with any treatment cost discussed with the physician that occurred.	Scale title: Satisfaction with any treatment cost discussed with the physician that occurred. Minimum = 1; Maximum = 5; higher is a better outcome.	Immediately after video-recorded patient-physician interaction
Primary	The observed frequency of a cost discussion assessed via an original coding system. Frequency is assessed as the number of distinct cost discussions that occur in each recorded interaction. Higher is a better outcome.	Observation of the frequency of a cost discussion. Minimum = 0; Maximum = undefined.	During the video-recorded patient-physician interaction
Primary	Patient-Centered Communication scale. The observed quality of patient-physician communication assessed a validated coding system. Minimum = 1; Maximum =5; higher is a better outcome	Observation of the quality of patient-physician communication.	During the video-recorded patient-physician interaction
Primary	Referral to social work/financial navigator	If the patient was referred to a social worker or financial navigator. The number of patients who receive a referral to a social worker or a financial navigator.	Immediately after video-recorded patient-physician interaction
Secondary	Self-efficacy in patient-physician interactions. An example item from the PEPPI scale: How confident are you in your ability to know what questions to ask your doctor? Data will be aggregated using means and standard deviations.	How efficacious patients feel about communicating with physicians. Scale title: Self-efficacy in patient-physician interactions. Minimum = 1; Maximum = 5; higher is a better outcome.	1, 3, 6, and 12 months after video-recorded patient-physician interaction
Secondary	Self-efficacy in managing treatment costs	How efficacious patients feel about managing their treatment costs. Scale title: Self-efficacy in managing treatment costs. Minimum = 1; Maximum = 5; higher is a better outcome.; An example item from the adapted scale: I am confident I can pay for the direct costs of my treatment.; Data will be aggregated using means and standard deviations.	1, 3, 6, and 12 months after video-recorded patient-physician interaction
Secondary	Financial toxicity	The experience of financial harm due to treatment cost. Rate of patients who indicate they are experiencing financial burden due to cancer treatment costs.	1, 3, 6, and 12 months after video-recorded patient-physician interaction
Secondary	Follow up with social work/financial navigator	If the patient followed up with social work/financial navigator if referred.; Data will be aggregated using frequency counts.	1, 3, 6, and 12 months after video-recorded patient-physician interaction
Secondary	Treatment adherence An example item from the Medical Outcomes Study General Adherence measure: I had a hard time doing what the doctor suggested I do for treating my cancer.	If the patient adhered to the recommended treatment	1, 3, 6, and 12 months after video-recorded patient-physician interaction
Secondary	Treatment-cost related adherence	If the patient was unable to adhere to treatment due to cost	1, 3, 6, and 12 months after video-recorded patient-physician interaction
Secondary	Clinical appointment adherence. The rate of appointments a patient is scheduled for and attends.	If the patient adhered to clinical appointments	1, 3, 6, and 12 months after video-recorded patient-physician interaction