SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This study evaluates whether daily SMS-based (text messages) symptom monitoring is feasible and acceptable in patients who are undergoing treatment for multiple myeloma (MM) or systemic light chain amyloidosis (AL), and whether it can help in early identification of symptoms that may require clinical attention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years
Diagnosis of MM or AL based on IMWG diagnostic criteria
Planned to start a new treatment within 14 days (+/-7 days)
Able to provide written informed consent
Disqualifiers
Not able to give informed consent
Trial population
Patients age ≥ 18 years who have a diagnosis of MM and/or AL amyloidosis and are planned to start treatment at Mayo Clinic or another treatment facility
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Engagement (Aim 1) - daily and weekly response rates
Engagement will be evaluated by daily and weekly response rates. A response rate of ≥60% to daily prompts (e.g., ≥4 days per week) will be considered acceptable engagement.
Time frame
Up to 3 months2
Engagement (Aim 1) - uninterrupted participation
Engagement will be evaluated by the duration (number of days) of uninterrupted participation (e.g., consecutive response to daily prompts with missed days).
Time frame
Up to 3 months3
Engagement (Aim 1) - complete symptom data
Engagement will be evaluated by the proportion of days with complete symptom data entered by participants.
Time frame
Up to 3 months4
Acceptability (Aim 1) - CSQ-8
Acceptability will be measured using a post study survey: Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is a self-report questionnaire used to measure general client satisfaction. It consists of 8 questions answered on a 4-point scale (e.g., quite dissatisfied, mildly dissatisfied, mostly satisfied, very satisfied). Total scores range from 8 to 32 with higher scores indicating higher satisfaction.
Time frame
Up to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov