Study Assessing the All4Cure Health Technology Intervention on Patient Activation in Multiple Myeloma

BACKGROUND

Over the past 2 decades, outcomes have improved markedly in patients with multiple myeloma, a result attributable to the development of highly effective agents such as immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies. However, multiple myeloma remains incurable despite these advances. Furthermore, with each successive relapse, the disease becomes increasingly resistant to treatment. Therefore, patients need methods to best identify those regimens most likely to benefit them.

All4Cure has built a myeloma-focused knowledge-sharing platform for patients, clinicians, and researchers. Patients register and sign HIPAA (Health Insurance Portability and Accountability Act) release forms allowing All4Cure to access all medical records from all institutions from which they have received care. A team of myeloma-dedicated medical data specialists then extracts information from the medical records and displays it on each patient's deidentified, personalized dashboard. Patient dashboards display results of monthly patient-reported outcome (PRO) surveys and feature a graph depicting all treatments and responses, from diagnosis to present. A summary is also provided, containing a narrative of the patient's relevant past medical history. This allows a community of >2000 participating patients, clinicians, and researchers to post comments, questions, or suggestions in a discussion panel. With >800 participating patients with multiple myeloma, All4Cure can help inform the treatment decisions of a patient and their oncologist by providing insight into the treatment choices and outcomes of hundreds of other patients.

Patient activation levels predict a broad range of health-related behaviors and outcomes and can be assessed using the 13-item Patient Activation Measure (PAM-13) instrument. Here we report an ongoing prospective cohort study to evaluate the impact of All4Cure enrollment on patient activation levels.

METHODS

The trial is enrolling 200 adults aged ≥18 years with a diagnosis of multiple myeloma. Patients unable to engage with the platform or who have previously enrolled in All4Cure are excluded. After providing informed consent, patients will complete quarterly PAM-13 surveys, monthly PRO assessments, and surveys to assess their attitudes regarding All4Cure at baseline and on completion of the 12-month study. Oncologists also consent to answer surveys to assess their attitudes regarding All4Cure at baseline and on study completion.

The primary objective of the trial is to assess the effect of All4Cure enrollment on patient activation as assessed using PAM-13. Secondary objectives include evaluation of the associations between patient activation and symptom burden and patient and physician expectations of the utility of the platform. The trial is registered at ClinicalTrials.gov (NCT05673083) and sponsored by the GSK Patient Empowerment Alliance, a program created to help test, measure, and validate tools that show potential to empower patients as core members of their oncology care team, with the goal of improving care outcomes.