None listed
Conditions
Brief 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.
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 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 com
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 120 No limit
Healthy volunteers
No
Inclusion criteria
Patients are eligible for this trial if: 1. Aged equal to or more than 18 years of age 2. Diagnosis of RMM 3. Patients must have commenced or be commencing a D, R or K based treatment, eligible for PBS reimbursement, as a second or later line of treatment 4. Patient must be consented to and registered on the Myeloma and Related Diseases Registry (MRDR) 5. Life expectancy > 12 months 6. Able to give informed consent for the trial, and willing and able to comply with each of the trial arms
Exclusion criteria
Patients will not be eligible for this trial if they fulfil any of the following criteria: 1. Patients who would not be able to complete the questionnaires for any reason 2. Treating team deems enrolment in the study is not in the best interests of the patient 3. Previous participation in this trial
Outcome results
None listed