DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Group 3: The DISCO App + Booster
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.
干预措施: Group 3: The DISCO App + Booster (Behavioral)
Group 2: The DISCO App
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.
干预措施: Group 2: The DISCO App (Behavioral)
Group 1: Usual Care
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.
干预措施: Group 1: Usual Care (Behavioral)
结局指标
主要结局
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.
时间窗: 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
时间窗: During the video-recorded patient-physician interaction
Observation of the quality of patient-physician communication.
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.
时间窗: 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.
时间窗: 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
时间窗: Immediately after video-recorded patient-physician interaction
Patient perception that treatment cost discussed with the physician
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.
时间窗: 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.
时间窗: 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.
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.
时间窗: 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.
Referral to social work/financial navigator
时间窗: 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.
次要结局
- 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)
- Follow up with social work/financial navigator(1, 3, 6, and 12 months after video-recorded patient-physician interaction)
- 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)
- 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)
- 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)
- Treatment-cost related adherence(1, 3, 6, and 12 months after video-recorded patient-physician interaction)
研究者
Lauren Hamel
Principal Investigator
Barbara Ann Karmanos Cancer Institute