None listed
Conditions
Brief summary
This study will test whether it is feasible to collect information on quality of life in patients living with myeloma and provide this to treating clinicians in real-time at clinical visits. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have newly diagnosed multiple myeloma for which you have not received any prior treatment or are within 7 days of day 1 of treatment. Study details Participants will be randomly allocated (by chance) to one of two groups. Participants in one group will complete a quality of life questionnaire before 4 clinical visits and a summary of results of concern are provided to the treating clinician before the first 3 visits. The clinician is made aware that results from the questionnaire summary are to be taken into account in the patient's care. Participants in the other group will complete the same questionnaire before visits 1 and 4 only, and results are not provided to the treating clinician. Feasibility of the intervention will be assessed by patient and clinician evaluation surveys, clinician interviews and site study coordinator observations. Quality of life scores will also be compared between groups. The theory is that increasing clinicians' awareness of issues affecting patients quality of life could help to improve patient care.
Interventions
This is a feasibility study. The patient completes the MyPOS quality of life questionnaire, which should take 7 to 8 minutes to complete, either by tablet whilst in the waiting room for their appointment, online (by emailed link) within a week of their visit, or by hard copy, before 4 clinical visits. The patient indicates whether they completed the questionnaire on their own or with help from a friend/relative or a staff member. A summary of results of concern is generated from the Myeloma and
This is a feasibility study. The patient completes the MyPOS quality of life questionnaire, which should take 7 to 8 minutes to complete, either by tablet whilst in the waiting room for their appointment, online (by emailed link) within a week of their visit, or by hard copy, before 4 clinical visits. The patient indicates whether they completed the questionnaire on their own or with help from a friend/relative or a staff member. A summary of results of concern is generated from the Myeloma and Related Diseases Registry electronic database by clicking a button and printing the summary. It is provided to the treating clinician by the study coordinator or clinic staff before the first 3 visits. The clinician is made aware that results from the questionnaire summary are to be taken into account in the patient's care by the study coordinator or by an explanatory statement left with the questionnaire summary for the clinician. Visits are: T1: close to diagnosis, T2: T1 + 1 month, T3: T1 + 6 months, T4: T1 + 10 months. After each of the first 3 visits the clinician completes an evaluation questionnaire to assess the feasibility of the intervention and after T3 the patient completes an evaluation questionnaire to assess the feasibility of the intervention.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with newly diagnosed multiple myeloma who have not received any prior treatment or they are within 7 days of day 1 of treatment.
Exclusion criteria
Patients who are not registered on the Myeloma and Related Diseases Registry
Outcome results
None listed