NCT04766190

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Feb 2021Aug 2028

First Submitted

Initial submission to the registry

February 10, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

6.6 years

First QC Date

February 10, 2021

Last Update Submit

May 21, 2025

Conditions

Keywords

Financial ToxicityCancerTreatment costPatient-provider communication

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

OTHER

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.

Behavioral: Group 1: Usual Care

Group 2: The DISCO App

OTHER

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.

Behavioral: Group 2: The DISCO App

Group 3: The DISCO App + Booster

OTHER

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.

Behavioral: Group 3: The DISCO App + Booster

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.

Group 2: The DISCO App

Patients randomized to this arm will receive usual care.

Group 1: 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.

Group 3: The DISCO App + Booster

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

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.

MeSH Terms

Conditions

Financial StressNeoplasmsBreast NeoplasmsProstatic Neoplasms

Interventions

Immunization, Secondary

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Lauren Hamel, PhD

    Barbara Ann Karmanos Cancer Insitute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Hamel, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
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

Locations