RecruitingACTRN12622001199707

Using real-time feedback of patient-reported outcome measures to direct delivery of standard-of-care therapies in relapsed multiple myeloma

A parallel, non-blinded, multicentre, Bayesian randomised controlled trial to evaluate the effect of real-time feedback of patient reported outcome measures (PROMs) to treating clinicians on event free survival in patients with relapsed multiple myeloma (RMM).

Sponsor

Monash University

Enrollment

200 participants

Start Date

Jun 13, 2023

Study Type

Interventional

Conditions

Relapsed Multiple Myeloma

Summary

The aim of this study is to determine whether real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians improves duration on treatment in patients with relapsed multiple myeloma receiving standard of care treatment, when compared to standard of care treatment alone. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of relapsed multiple myeloma, and have or are commencing a lenalidomide, carfilzomib, or daratumumab based treatment regimen. Study details Participants will be randomised (i.e. allocated by chance) to receive standard of care treatment plus real-time feedback of PROMs, or to receive standard of care treatment alone. Participants in the intervention group will be asked to complete a multiple myeloma-specific quality of life questionnaire (myPOS) within the week before each clinical visit using an online PROM collection system. Participants receiving daratumumab or carfilzomib based regimens will also complete additional questions regarding treatment-specific side effects at this time. The questionnaires will take approximately 10 minutes to complete, and will be completed prior to a total of 13 visits over a period of 12 months. A summary of the completed questionnaires with results of concern will be provided to your treating clinician before clinical visits, so that the results may be considered in your care. Participants in the standard of care alone group will not complete the MyPOS questionnaire prior to clinic visits. All participants will be asked to complete a quality of life questionnaire and a treatment satisfaction questionnaire every three months. Participants in the standard of care alone group, receiving daratumumab or carfilzomib based regimens, will also be asked to complete the additional questions regarding treatment-specific side effects every 3 months. After a period of 12 months, all participants will have data collected from their medical records on time to discontinuation of treatment, disease progression, and survival, and will complete questionnaires regarding quality of life, side effects, and treatment satisfaction. It is hoped that this study may show that real-time feedback of patient-reported outcome measures (PROMs) to treating clinicians at clinic visits improves duration on treatment and survival when compared to patients on standard of care alone.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When people with multiple myeloma are on treatment, small day-to-day symptoms — fatigue, pain, nausea, or anxiety — can significantly affect how long they stay on their medication. If doctors know about these concerns in real time rather than only learning about them at a clinic visit, they can address them earlier and potentially help patients tolerate treatment longer. This study tests whether giving treating doctors a real-time summary of how patients are actually feeling (using validated questionnaires completed at home before each visit) leads to better outcomes. Participants are randomly assigned to either complete a myeloma-specific quality of life questionnaire (called myPOS) before each clinic visit — with a summary automatically sent to their doctor — or to receive standard care only. After 12 months, the researchers will look at how long people stayed on their treatment, how their disease progressed, and their overall survival. You may be eligible if you are 18 or older, have relapsed multiple myeloma, and are starting or already on a treatment regimen containing lenalidomide, carfilzomib, or daratumumab. You must also be registered on the Australian Myeloma and Related Diseases Registry. Patients who cannot complete questionnaires for any reason would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention Arm: Standard of Care (SoC) treatment plus real-time feedback of patient reported outcome measures (PROMs), including the MyPOS questionnaire and regimen specific questions, to clinicia

Intervention Arm: Standard of Care (SoC) treatment plus real-time feedback of patient reported outcome measures (PROMs), including the MyPOS questionnaire and regimen specific questions, to clinicians. Eligible SoC regimens are Lenalidomide (R), Carfilzomib (K) or Daratumumab (D) based regimens. Participants will complete a multiple myeloma (MM)-specific PROM (MyPOS) within the week before each clinical visit using an online PROM collection system, which takes approximately 10 minutes to complete; completion in the clinic will also be possible if needed. Additional questions (no more than 5) will be added to ensure symptoms for common side effects of specific regimens (D or K based regimens) are covered, no more than 10 minutes to complete. Questionnaire access will be sent to participants via email each month, through a secure link. A summary of the completed MyPOS (plus/minus additional items) with results of concern only (set according to agreed parameters) and any free text will be provided to clinicians before clinical visits, to be incorporated in the patient’s care at their discretion. Questionnaire completion will be assessed by audit of the trial database. A reminder to complete the PROMS will be sent to participants the day before their visit, if not yet completed. There will be a total of 13 standard of care visits over a 12 month period (day 1, months 1 to 12) where trial data will be collected, with the questionnaires being completed ahead of visits 13 times.