Frankford

Researchers are evaluating the feasibility and acceptability of completing patient-reported outcomes (PROs) among adolescents and young adults (AYAs) aged 18 to 39 with various types of cancer. This pilot randomized controlled trial compares two approaches: allowing AYAs to choose five health-related quality of life (HRQOL) domains to report on (Choice PRO) versus assigning five fixed domains (Fixed PRO). The study aims to improve how PRO data is collected and used to better address patient needs in clinical and supportive care settings. Participants will be randomly assigned to either the Choice PRO group, where they select five of 15 PRO domains to complete at each assessment, or the Fixed PRO group, where they complete the same five predetermined domains at each time point. Assessments will be completed online using the EASEE-PRO platform at baseline and 1, 3, 6, and 12 months. Reminder calls and text messages will be used to encourage adherence and reduce missing data. The study will also explore how AYAs want their PRO data shared with themselves, their families, and healthcare providers. During the study, participants will complete questionnaires combining computerized adaptive tests and fixed short forms. Researchers will measure the completion rates and acceptability of the PROs at one month and baseline, respectively, and compare these between groups. The study requires participants to have internet access and the ability to provide informed consent and accurate self-reports. The total participation time includes follow-up over one year with multiple assessments to capture patient experiences and preferences.

Researchers are evaluating a connected customized treatment platform called CONCURxP to help patients with metastatic breast cancer adhere to their CDK4/6 inhibitor medication schedules. The study compares CONCURxP, which combines a WiseBag medication monitoring device with personalized text message reminders and healthcare provider follow-ups, to enhanced usual care where patients only use the WiseBag and receive educational materials. This research aims to improve medication adherence, symptom management, quality of life, and communication between patients and providers over a 12-month period. Participants are randomly assigned to one of two groups: Arm A uses the WiseBag and receives educational materials every four weeks for 12 months, while Arm B uses the WiseBag along with personalized text message reminders and healthcare provider follow-ups as part of the CONCURxP program. Patients in Arm B may also complete an interview within six months after study completion. A separate group, Arm C, includes non-patient participants who complete an interview 15 to 39 months after the first patient enrollment. After the intervention period, patients may be monitored for an additional six months. During the study, participants' medication adherence is tracked electronically using the WiseBag at 12 months after starting medication. Researchers also assess self-reported adherence, symptom burden, quality of life, patient-provider communication, self-efficacy for symptom management, financial worry, healthcare use, and survival outcomes. Patient interviews and electronic health record reviews support the collection of these data. The study involves surveys, text messaging, medication tracking, and follow-ups to understand and improve adherence and overall patient experience.

Researchers are studying patients with metastatic HER-2-positive breast cancer who are receiving trastuzumab-based treatments to understand the risk of heart problems related to their cancer therapy. The study includes two groups: one large observational group of patients already taking beta blockers, ACE inhibitors, or ARBs alongside their cancer treatment, and a smaller randomized group comparing patients who receive carvedilol, a heart medication, to those who do not. The trial aims to assess how often heart issues occur and whether carvedilol can help prevent heart damage from chemotherapy. It also investigates biomarkers and heart function measures as predictors of cardiac risk. In the randomized part, patients not already on beta blockers, ACE inhibitors, or ARBs are assigned to receive carvedilol twice daily or no additional treatment for up to 108 weeks, with treatment cycles repeated every 12 weeks if there is no disease progression or unacceptable side effects. Patients already taking these heart medications join the observational cohort and are monitored for up to 108 weeks without any change in their therapy. The study collects blood samples and performs regular heart imaging to evaluate heart function and strain. Participants will have regular echocardiograms every 12 weeks to monitor heart function, with both local and central readings compared. Blood samples are collected for biomarker analysis, and patient health status is assessed throughout the study. The main outcome measured is the time until any heart dysfunction is first detected, followed for up to 108 weeks. The study also tracks interruptions in cancer therapy due to heart problems and explores genetic and plasma markers that might predict heart risk. Participants are followed closely for safety and treatment effects during the entire study period.

Researchers are evaluating a combination therapy for adults with newly diagnosed multiple myeloma, a type of plasma cell cancer. This phase III trial compares a four-drug combination including daratumumab, bortezomib, lenalidomide, and dexamethasone to a three-drug combination without bortezomib. The study aims to determine if adding bortezomib improves overall survival, especially in patients with minimal residual disease (MRD), while also assessing side effects, progression-free survival, and patient-reported outcomes related to quality of life and neuropathy. Treatment begins with a standard induction phase where all patients receive daratumumab subcutaneously, lenalidomide orally, and dexamethasone orally over nine 28-day cycles. After induction, patients are randomized to receive consolidation therapy either with the four-drug combination including bortezomib or the three-drug combination without bortezomib for nine additional 28-day cycles. Following consolidation, maintenance therapy with daratumumab and lenalidomide is given in repeated 28-day cycles until disease progression or unacceptable side effects occur. The study also incorporates imaging and biomarker assessments to evaluate treatment response and risk. Participants undergo regular evaluations including blood tests, bone marrow biopsies, and imaging scans to monitor disease status and treatment effects. Patient-reported questionnaires assess quality of life and symptoms such as neuropathy. After treatment, follow-up visits occur every three months for up to two years, then every six months for three years, and annually thereafter for up to 15 years. The primary outcome measured is overall survival from the time of randomization to the date of death or last known alive status.