SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders

OTHER

Non-Interventional Study

Non-interventional study

Engagement (Aim 1) - daily and weekly response rates

Time frame: Up to 3 months

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.

Engagement (Aim 1) - uninterrupted participation

Time frame: Up to 3 months

Engagement will be evaluated by the duration (number of days) of uninterrupted participation (e.g., consecutive response to daily prompts with missed days).

Engagement (Aim 1) - complete symptom data

Time frame: Up to 3 months

Engagement will be evaluated by the proportion of days with complete symptom data entered by participants.

Acceptability (Aim 1) - CSQ-8

Time frame: Up to 3 months

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.

System-generated alerts (Aim 2)

Time frame: Up to 3 months

Will determine the proportion of alerts that prompt documented clinical actions (e.g., triage calls, provider outreach, medication adjustments, referrals, and/or unplanned visits). Alerts will be considered effective if ≥30% of alerts prompt clinical actions.

Symptom and Quality of Life (QOL) trajectories (Aim 3) - PROMIS-29

Time frame: Baseline to 3 months

Daily symptom and quality of life (QOL) trajectories will be modeled across treatment cycles. The Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) is used to assess patient-reported outcomes over the past 7 days across seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles participation, and pain interference. Scores are scaled so that an average person would have a score of 50. Higher scores indicate more of the item being measured. Raw scores are converted to T-scores, with higher scores indicating better quality of life (QOL). Changes in PROMIS-29 scores will be evaluated using established minimal clinically important differences (MCIDs). Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.

Symptom and QOL trajectories (Aim 3) - SF-36

Time frame: Baseline to 3 months

Daily symptom trajectories will be modeled across treatment cycles. The 36-Item Short Form Survey (SF-36) is used to measure patient health and disability. Participants rate items on a scale of 1 (all of the time) to 6 (none of the time) or 1 (not at all) to 5 (extremely) with higher scores indicating greater quality of life. Changes in SF-36 scores will be evaluated using established MCIDs. Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.

Change in Frailty status (Aim 4) - IMWG-FI

Time frame: Baseline to 3 months

Frailty will be assessed using the International Myeloma Working Group-Frailty Index (IMWG-FI). The IMWG-FI will be analyzed as a continuous and categorical variable; patients will be classified into 3 categories (fit, intermediate fit, or frail). Total scores range from 0-5, with a score of 0 indicating fit, a score of 1 indicating intermediate fitness, and a score of ≥2 indicating frailty.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.