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Financial ToxicityDISCONCT04766190

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

A study testing Group 2: The DISCO App and Group 3: The DISCO App + Booster in people with Financial Toxicity and Cancer, run by Lauren Hamel at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Financial Toxicity, Cancer, Question Prompt List
What is being tested?
Group 2: The DISCO App and Group 3: The DISCO App + Booster
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
1 siteUnited States
Study dates
10 Feb 2021to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

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.

Read the 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.

Being tested
Group 2: The DISCO App, Group 1: Usual Care, Group 3: The DISCO App + Booster
Keywords
Financial Toxicity, Cancer, Treatment cost, Patient-provider communication
Medical subject headings
Financial Stress, Neoplasms, Breast Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group 2: The DISCO AppBehavioural

    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 CareBehavioural

    Patients randomized to this arm will receive usual care.

  • Group 3: The DISCO App + BoosterBehavioural

    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.

Study groups in NCT04766190
Study groupRoleWhat they receive
Group 1: Usual CareOtherThe 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.
Receives: Behavioral: Group 1: Usual Care
Group 2: The DISCO AppOtherThe 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.
Receives: Behavioral: Group 2: The DISCO App
Group 3: The DISCO App + BoosterOtherThe 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.
Receives: Behavioral: Group 3: The DISCO App + Booster

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediately after the video-recorded patient-physician interaction

  2. 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.

    Measured: Immediately after video-recorded patient-physician interaction

  3. 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

    Measured: Immediately after video-recorded patient-physician interaction

  4. 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.

    Measured: Immediately after video-recorded patient-physician interaction

  5. Perceived presence of treatment cost discussion

    Patient perception that treatment cost discussed with the physician

    Measured: Immediately after video-recorded patient-physician interaction

  6. 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.

    Measured: Immediately after video-recorded patient-physician interaction

  7. 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.

    Measured: During the video-recorded patient-physician interaction

  8. 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.

    Measured: During the video-recorded patient-physician interaction

  9. 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.

    Measured: Immediately after video-recorded patient-physician interaction

Secondary outcomes (7)
  1. 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.

    Measured: 1, 3, 6, and 12 months after video-recorded patient-physician interaction

  2. 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.

    Measured: 1, 3, 6, and 12 months after video-recorded patient-physician interaction

  3. 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.

    Measured: 1, 3, 6, and 12 months after video-recorded patient-physician interaction

  4. 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.

    Measured: 1, 3, 6, and 12 months after video-recorded patient-physician interaction

  5. 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

    Measured: 1, 3, 6, and 12 months after video-recorded patient-physician interaction

  6. Treatment-cost related adherence

    If the patient was unable to adhere to treatment due to cost

    Measured: 1, 3, 6, and 12 months after video-recorded patient-physician interaction

  7. Clinical appointment adherence. The rate of appointments a patient is scheduled for and attends.

    If the patient adhered to clinical appointments

    Measured: 1, 3, 6, and 12 months after video-recorded patient-physician interaction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2021
  2. Study start10 Feb 2021
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04766190
Sponsor's protocol ID
2020-117
Other IDs
RSG-20-026-01 - CPHPS
Acronym
DISCO
Status last verified
Jul 2026
First submitted
10 Feb 2021
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34535162

Questions about this trial

What is this clinical trial studying?

A study testing Group 2: The DISCO App and Group 3: The DISCO App + Booster in people with Financial Toxicity and Cancer, run by Lauren Hamel at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Immediately after the video-recorded patient-physician interaction). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04766190, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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