DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
DISCO
2 other identifiers
interventional
260
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2021
CompletedStudy Start
First participant enrolled
February 10, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
May 25, 2025
May 1, 2025
6.6 years
February 10, 2021
May 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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
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
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
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
Perceived presence of treatment cost discussion
Patient perception that treatment cost discussed with the physician
Immediately after video-recorded patient-physician interaction
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
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
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
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 Outcomes (7)
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.
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Self-efficacy in managing treatment costs
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Financial toxicity
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Follow up with social work/financial navigator
1, 3, 6, and 12 months after video-recorded patient-physician interaction
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.
1, 3, 6, and 12 months after video-recorded patient-physician interaction
- +2 more secondary outcomes
Other Outcomes (3)
Assessment of the intervention.
Immediately after video-recorded patient-physician interaction
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.
1 month after the video-recorded patient-physician interaction
Intervention presence in video-recorded patient-physician interaction
During the video-recorded patient-physician interaction
Study Arms (3)
Group 1: Usual Care
OTHERThe 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 2: The DISCO App
OTHERThe 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 3: The DISCO App + Booster
OTHERThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lauren Hamellead
Study Sites (1)
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Related Publications (1)
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.
PMID: 34535162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren Hamel, PhD
Barbara Ann Karmanos Cancer Insitute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2021
First Posted
February 23, 2021
Study Start
February 10, 2021
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
May 25, 2025
Record last verified: 2025-05