Back to resultsDISCO: A Patient Intervention to Reduce the Financial Burden of Cancer (DISCO)
Primary Purpose
Financial Toxicity, Cancer, Question Prompt List
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group 2: The DISCO App
Group 1: Usual Care
Group 3: The DISCO App + Booster
Sponsored by
About this trial
This is an interventional health services research trial for Financial Toxicity focused on measuring Financial Toxicity, Cancer, Treatment cost, Patient-provider communication
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:
-
Sites / Locations
- Barbara Ann Karmanos Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Group 1: Usual Care
Group 2: The DISCO App
Group 3: The DISCO App + Booster
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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
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.
Perceived presence of treatment cost discussion
Patient perception that treatment cost discussed with the physician
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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
Treatment-cost related adherence
If the patient was unable to adhere to treatment due to cost
Clinical appointment adherence. The rate of appointments a patient is scheduled for and attends.
If the patient adhered to clinical appointments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04766190
Brief Title
DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
Acronym
DISCO
Official Title
DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lauren Hamel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Financial Toxicity, Cancer, Question Prompt List, Breast Cancer, Prostate Cancer
Keywords
Financial Toxicity, Cancer, Treatment cost, Patient-provider communication
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Usual Care
Arm Type
Other
Arm Description
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.
Arm Title
Group 2: The DISCO App
Arm Type
Other
Arm Description
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.
Arm Title
Group 3: The DISCO App + Booster
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group 2: The DISCO App
Intervention Description
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
Intervention Name(s)
Group 1: Usual Care
Intervention Description
Patients randomized to this arm will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Group 3: The DISCO App + Booster
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Immediately after the video-recorded patient-physician interaction
Title
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.
Description
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.
Time Frame
Immediately after video-recorded patient-physician interaction
Title
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.
Description
If patients know the types of cost associated with cancer treatment
Time Frame
Immediately after video-recorded patient-physician interaction
Title
Perceived financial toxicity; Scale title: Adapted Comprehensive score for financial toxicity (COST) measure.
Description
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.
Time Frame
Immediately after video-recorded patient-physician interaction
Title
Perceived presence of treatment cost discussion
Description
Patient perception that treatment cost discussed with the physician
Time Frame
Immediately after video-recorded patient-physician interaction
Title
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.
Description
Scale title: Satisfaction with any treatment cost discussed with the physician that occurred. Minimum = 1; Maximum = 5; higher is a better outcome.
Time Frame
Immediately after video-recorded patient-physician interaction
Title
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.
Description
Observation of the frequency of a cost discussion. Minimum = 0; Maximum = undefined.
Time Frame
During the video-recorded patient-physician interaction
Title
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
Description
Observation of the quality of patient-physician communication.
Time Frame
During the video-recorded patient-physician interaction
Title
Referral to social work/financial navigator
Description
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.
Time Frame
Immediately after video-recorded patient-physician interaction
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Title
Self-efficacy in managing treatment costs
Description
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.
Time Frame
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Title
Financial toxicity
Description
The experience of financial harm due to treatment cost. Rate of patients who indicate they are experiencing financial burden due to cancer treatment costs.
Time Frame
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Title
Follow up with social work/financial navigator
Description
If the patient followed up with social work/financial navigator if referred.
Data will be aggregated using frequency counts.
Time Frame
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Title
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.
Description
If the patient adhered to the recommended treatment
Time Frame
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Title
Treatment-cost related adherence
Description
If the patient was unable to adhere to treatment due to cost
Time Frame
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Title
Clinical appointment adherence. The rate of appointments a patient is scheduled for and attends.
Description
If the patient adhered to clinical appointments
Time Frame
1, 3, 6, and 12 months after video-recorded patient-physician interaction
Other Pre-specified Outcome Measures:
Title
Assessment of the intervention.
Description
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.
Time Frame
Immediately after video-recorded patient-physician interaction
Title
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.
Description
Patient perceptions of the intervention booster's usefulness
Time Frame
1 month after the video-recorded patient-physician interaction
Title
Intervention presence in video-recorded patient-physician interaction
Description
If the interaction is visible in the video-recorded patient-physician interaction
Time Frame
During the video-recorded patient-physician interaction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Hamel, PhD
Phone
313-576-9672
Email
hamell@karmanos.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Hamel, PhD
Organizational Affiliation
Barbara Ann Karmanos Cancer Insitute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Hamel, PhD
Phone
313-576-9672
Email
hamell@karmanos.org
First Name & Middle Initial & Last Name & Degree
Susan Eggly, PhD
First Name & Middle Initial & Last Name & Degree
Seongho Kim, PhD
First Name & Middle Initial & Last Name & Degree
Elisabeth Heath, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
34535162
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.
Results Reference
derived
Learn more about this trial
DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
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