- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04766190
DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer (DISCO)
Study Overview
Status
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lauren Hamel, PhD
- Phone Number: 313-576-9672
- Email: hamell@karmanos.org
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48201
- Recruiting
- Barbara Ann Karmanos Cancer Institute
-
Contact:
- Lauren Hamel, PhD
- Phone Number: 313-576-9672
- Email: hamell@karmanos.org
-
Sub-Investigator:
- Susan Eggly, PhD
-
Sub-Investigator:
- Seongho Kim, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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. |
Patients randomized to this arm will receive usual care.
|
Other: 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. |
Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist.
|
Other: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: Immediately after the video-recorded patient-physician interaction
|
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.
Time Frame: Immediately after video-recorded patient-physician interaction
|
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.
Time Frame: Immediately after video-recorded patient-physician interaction
|
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.
Time Frame: Immediately after video-recorded patient-physician interaction
|
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
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Perceived presence of treatment cost discussion
Time Frame: Immediately after video-recorded patient-physician interaction
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Patient perception that treatment cost discussed with the physician
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Immediately after video-recorded patient-physician interaction
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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.
Time Frame: Immediately after video-recorded patient-physician interaction
|
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.
Time Frame: During the video-recorded patient-physician interaction
|
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
Time Frame: During the video-recorded patient-physician interaction
|
Observation of the quality of patient-physician communication.
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During the video-recorded patient-physician interaction
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Referral to social work/financial navigator
Time Frame: Immediately after video-recorded patient-physician interaction
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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.
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Immediately after video-recorded patient-physician interaction
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
|
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
|
Self-efficacy in managing treatment costs
Time Frame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
|
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
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Financial toxicity
Time Frame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
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The experience of financial harm due to treatment cost.
Rate of patients who indicate they are experiencing financial burden due to cancer treatment costs.
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1, 3, 6, and 12 months after video-recorded patient-physician interaction
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Follow up with social work/financial navigator
Time Frame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
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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
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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.
Time Frame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
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If the patient adhered to the recommended treatment
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1, 3, 6, and 12 months after video-recorded patient-physician interaction
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Treatment-cost related adherence
Time Frame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
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If the patient was unable to adhere to treatment due to cost
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1, 3, 6, and 12 months after video-recorded patient-physician interaction
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Clinical appointment adherence. The rate of appointments a patient is scheduled for and attends.
Time Frame: 1, 3, 6, and 12 months after video-recorded patient-physician interaction
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If the patient adhered to clinical appointments
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1, 3, 6, and 12 months after video-recorded patient-physician interaction
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the intervention.
Time Frame: Immediately after video-recorded patient-physician interaction
|
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
|
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.
Time Frame: 1 month after the video-recorded patient-physician interaction
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Patient perceptions of the intervention booster's usefulness
|
1 month after the video-recorded patient-physician interaction
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Intervention presence in video-recorded patient-physician interaction
Time Frame: During the video-recorded patient-physician interaction
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If the interaction is visible in the video-recorded patient-physician interaction
|
During the video-recorded patient-physician interaction
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lauren Hamel, PhD, Barbara Ann Karmanos Cancer Insitute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-117
- RSG-20-026-01 - CPHPS (Other Grant/Funding Number: American Cancer Society)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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