[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04766190":3,"trial-entities:NCT04766190":133,"trial-summary:NCT04766190":141},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":47,"secondary_outcomes":78,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":14,"eligibility_criteria":102,"std_ages":108,"locations":111,"central_contacts":121,"overall_officials":122,"references":127,"see_also_links":132},"NCT04766190","2020-117","DISCO: A Patient Intervention to Reduce the Financial Burden of Cancer","ACTIVE_NOT_RECRUITING","2028-08-31","2026-07","2026-08-06","2021-02-10","Lauren Hamel","OTHER",false,"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.","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.",[18,19,20,21,22],"Financial Toxicity","Cancer","Question Prompt List","Breast Cancer","Prostate Cancer",[18,19,24,25],"Treatment cost","Patient-provider communication","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[29],"NA",{"count":31,"type":32},254,"ACTUAL",[34,39,43],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Group 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.",[36],{"type":35,"name":40,"description":41,"armGroupLabels":42},"Group 1: Usual Care","Patients randomized to this arm will receive usual care.",[40],{"type":35,"name":44,"description":45,"armGroupLabels":46},"Group 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.",[44],[48,52,56,59,62,65,68,72,75],{"measure":49,"description":50,"timeFrame":51},"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",{"measure":53,"description":54,"timeFrame":55},"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",{"measure":57,"description":58,"timeFrame":55},"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",{"measure":60,"description":61,"timeFrame":55},"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.",{"measure":63,"description":64,"timeFrame":55},"Perceived presence of treatment cost discussion","Patient perception that treatment cost discussed with the physician",{"measure":66,"description":67,"timeFrame":55},"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.",{"measure":69,"description":70,"timeFrame":71},"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",{"measure":73,"description":74,"timeFrame":71},"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.",{"measure":76,"description":77,"timeFrame":55},"Referral to social work\u002Ffinancial 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.",[79,81,84,87,90,93,96],{"measure":49,"description":50,"timeFrame":80},"1, 3, 6, and 12 months after video-recorded patient-physician interaction",{"measure":82,"description":83,"timeFrame":80},"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.\n\nAn example item from the adapted scale: I am confident I can pay for the direct costs of my treatment.\n\nData will be aggregated using means and standard deviations.",{"measure":85,"description":86,"timeFrame":80},"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.",{"measure":88,"description":89,"timeFrame":80},"Follow up with social work\u002Ffinancial navigator","If the patient followed up with social work\u002Ffinancial navigator if referred.\n\nData will be aggregated using frequency counts.",{"measure":91,"description":92,"timeFrame":80},"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",{"measure":94,"description":95,"timeFrame":80},"Treatment-cost related adherence","If the patient was unable to adhere to treatment due to cost",{"measure":97,"description":98,"timeFrame":80},"Clinical appointment adherence. The rate of appointments a patient is scheduled for and attends.","If the patient adhered to clinical appointments","ALL","18 Years",null,{"inclusion":103,"exclusion":106,"raw_text":107},[104,105],"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",[],"Inclusion Criteria:\n\n* 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.\n* 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\n\nExclusion Criteria:\n\n\\-",[109,110],"ADULT","OLDER_ADULT",[112],{"facility":113,"city":114,"state":115,"zip":116,"country":117,"geoPoint":118},"Barbara Ann Karmanos Cancer Institute","Detroit","Michigan","48201","United States",{"lat":119,"lon":120},42.33143,-83.04575,[],[123],{"name":124,"affiliation":125,"role":126},"Lauren Hamel, PhD","Barbara Ann Karmanos Cancer Insitute","PRINCIPAL_INVESTIGATOR",[128],{"pmid":129,"type":130,"citation":131},"34535162","DERIVED","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\u002Fs13063-021-05593-y.",[],{"nct_id":4,"conditions":134,"biomarkers":140},[135,136,137,138,139],"Breast Carcinoma","Colorectal Carcinoma","Lung Carcinoma","Prostate Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":142,"summary":143,"prompt_version":153},true,{"design":144,"status":145,"heading":146,"summary":147,"follow_up":148,"word_count":149,"commitments":150,"compensation":151,"drugs_mentioned":152},"This is an interventional study with 254 planned participants. Participants will be randomly assigned to one of three groups: the DISCO App, usual care, or the DISCO App plus a booster email.","completed","DISCO: Reducing Financial Burden of Cancer","This study, called DISCO, is looking at ways to help cancer patients manage the financial challenges that can come with treatment. It tests an iPad app, the DISCO App, which provides education about treatment costs and helps you talk to your doctor about them. Some participants will use the app, some will use the app with a follow-up email, and others will receive usual care. The study wants to see if using the app helps you feel more confident in discussing costs with your doctor and managing them, and if it increases your knowledge about treatment costs. You may be able to join if you are an adult with a new diagnosis of breast or prostate cancer, can read English, and have an email account. The current recruitment status is unclear.","Your confidence and knowledge will be measured immediately after your video-recorded interaction with your doctor.",131,"Participants in the DISCO App groups will use an iPad app before meeting with their oncologist. One group will also receive a follow-up email two months later.","Not stated in the trial record.",[],"v2"]