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Active, Not Recruiting

NCT Number: NCT04766190

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Financial Toxicity Behavior Behavioral Symptoms Breast Cancer Breast Diseases Breast Neoplasms Cancer Financial Stress Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Question Prompt List Skin Diseases Skin and Connective Tissue Diseases Stress, Psychological Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Group 2: The DISCO App

Behavioral

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 Care

Behavioral

Patients randomized to this arm will receive usual care.

Group 3: The DISCO App + Booster

Behavioral

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 outcomes

  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.

    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.

  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.

    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.

  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.

    Time frame: Immediately after video-recorded patient-physician interaction

    If patients know the types of cost associated with cancer treatment

  4. 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.

  5. Perceived presence of treatment cost discussion

    Time frame: Immediately after video-recorded patient-physician interaction

    Patient perception that treatment cost discussed with the physician

  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.

    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.

  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.

    Time frame: During the video-recorded patient-physician interaction

    Observation of the frequency of a cost discussion. Minimum = 0; Maximum = undefined.

  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

    Time frame: During the video-recorded patient-physician interaction

    Observation of the quality of patient-physician communication.

  9. Referral to social work/financial navigator

    Time frame: Immediately after video-recorded patient-physician interaction

    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 outcomes

  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.

    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.

  2. 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.

  3. Financial toxicity

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

    The experience of financial harm due to treatment cost. Rate of patients who indicate they are experiencing financial burden due to cancer treatment costs.

  4. Follow up with social work/financial navigator

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

    If the patient followed up with social work/financial navigator if referred.

    Data will be aggregated using frequency counts.

  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.

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

    If the patient adhered to the recommended treatment

  6. Treatment-cost related adherence

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

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

  7. 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

    If the patient adhered to clinical appointments

Other outcomes

  1. 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.

  2. 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

    Patient perceptions of the intervention booster's usefulness

  3. Intervention presence in video-recorded patient-physician interaction

    Time frame: During the video-recorded patient-physician interaction

    If the interaction is visible in the video-recorded patient-physician interaction

Sponsors and collaborators

Lead sponsor

Lauren Hamel

Other

Registry information

Acronym: DISCO

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2021
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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