Clinical trial NCT04766190: DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
Official title: DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Financial Toxicity
Cancer
Question Prompt List
Breast Cancer
Prostate Cancer
Keywords: Financial Toxicity
Cancer
Treatment cost
Patient-provider communication
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: 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.
timeFrame: Immediately after the video-recorded patient-physician interaction
measure: 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.
timeFrame: Immediately after video-recorded patient-physician interaction
measure: 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.
timeFrame: Immediately after video-recorded patient-physician interaction
measure: Perceived financial toxicity; Scale title: Adapted Comprehensive score for financial toxicity (COST) measure.
timeFrame: Immediately after video-recorded patient-physician interaction
measure: Perceived presence of treatment cost discussion
timeFrame: Immediately after video-recorded patient-physician interaction
measure: 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.
timeFrame: Immediately after video-recorded patient-physician interaction
measure: 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.
timeFrame: During the video-recorded patient-physician interaction
measure: 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
timeFrame: During the video-recorded patient-physician interaction
measure: Referral to social work/financial navigator
timeFrame: Immediately after video-recorded patient-physician interaction
Secondary outcomes:
measure: 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.
timeFrame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
measure: Self-efficacy in managing treatment costs
timeFrame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
measure: Financial toxicity
timeFrame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
measure: Follow up with social work/financial navigator
timeFrame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
measure: 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.
timeFrame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
measure: Treatment-cost related adherence
timeFrame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
measure: Clinical appointment adherence. The rate of appointments a patient is scheduled for and attends.
timeFrame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
Other outcomes:
measure: Assessment of the intervention.
timeFrame: Immediately after video-recorded patient-physician interaction
measure: 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.
timeFrame: 1 month after the video-recorded patient-physician interaction
measure: Intervention presence in video-recorded patient-physician interaction
timeFrame: During the video-recorded patient-physician interaction
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Insitute
name: Lauren Hamel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.