Breast Cancer, Cancer, Financial Toxicity, Prostate Cancer, Question Prompt List
Conditions
Keywords
Financial Toxicity, Cancer, Treatment cost, Patient-provider communication
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.
Interventions
BEHAVIORALGroup 2: The DISCO 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.
BEHAVIORALGroup 1: Usual Care
Patients randomized to this arm will receive usual care.
BEHAVIORALGroup 3: The DISCO App + Booster
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.
Sponsors
Lauren Hamel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | Immediately after video-recorded patient-physician interaction | If patients know the types of cost associated with cancer treatment |
| Perceived financial toxicity; Scale title: Adapted Comprehensive score for financial toxicity (COST) measure. | 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. |
| Perceived presence of treatment cost discussion | Immediately after video-recorded patient-physician interaction | 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. | 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. |
| 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. | During the video-recorded patient-physician interaction | 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 | During the video-recorded patient-physician interaction | Observation of the quality of patient-physician communication. |
| Referral to social work/financial navigator | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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. |
| Financial toxicity | 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. |
| Follow up with social work/financial navigator | 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. |
| 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 | If the patient adhered to the recommended treatment |
| Treatment-cost related adherence | 1, 3, 6, and 12 months after video-recorded patient-physician interaction | 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. | 1, 3, 6, and 12 months after video-recorded patient-physician interaction | If the patient adhered to clinical appointments |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren Hamel, PhD
Barbara Ann Karmanos Cancer Insitute
Outcome results
None listed