PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPack Health
About this trial
This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM). One hundred adults with R/R MM will be enrolled at The University of Washington. Individuals who agree to take part in the study and sign an informed consent will be enrolled in a 3-month digital health coaching program. The program will provide weekly phone calls plus the delivery of learning materials to text or email. Questionnaires and data from a wrist-worn activity tracker will be collected. Outcomes include treatment and symptom experience, quality of life, financial burden, and how confident people feel to manage their health. Information about your condition and treatment will be collected, along with how often you use services like the emergency room, for care. This data will provide a better understanding of how a person experiences their R/R MM.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible.
Initiation of at least the second line of MM-directed therapy for multiple myeloma at time of study enrollment. Participants must have been exposed to at least one proteasome inhibitor (PI) and/or one immunomodulatory drug (IMiD).
Disqualifiers
Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
Individuals who have previously participated in Pack Health digital health coaching
Physician-assessed lack of sufficient English proficiency
Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application
Trial design
Design model
Single group
Treatments tested in this trial
Digital Health Coaching Program
BehavioralDigital health intervention consisting of weekly calls from a Health Advisor to a participant, accompanied by delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.
Fitbit
DeviceA wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Single Arm Cohort Receiving Digital Health CoachingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Feasibility of the Digital Health Coaching Intervention
A retention rate greater than or equal to 70%. Retention is defined as individuals who agree to participate in the digital health coaching program and complete the 3 months of engagement post-enrollment. Engagement is defined as the completion of 1 nudge (call, text, or email) per module out of 5 nudge opportunities
Time frame
At 3 months following the start of the coaching interventionSecondary outcomes
1
Change in Cancer Behavior Inventory-Brief Form (CBI-B)
This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".
Time frame
Change in baseline perception of treatment experience at 3 monthsOther outcomes
1
Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index
The Center for Adherence Support Evaluation (CASE) is a three-item questionnaire used to measure antiretroviral therapy adherence. This questionnaire was developed through the Special Projects of National Significance (SPNS) initiative called Assessing Existing Efforts to Increase Adherence to Medication. Patients take less than 5 minutes to answer the three unique questions, asking about their difficulty taking medications on time, average days per week with one dose missed, and the last time they missed a dose.
Time frame
Change in baseline perception of treatment experience at 3 months2
Change in Comprehensive Score for Financial Toxicity (COST) Instrument
The Comprehensive Score for Financial Toxicity (COST) is an 11-item instrument used to measure the financial toxicity of cancer treatment, which has been demonstrated to be highly correlated with HRQoL (de Souza et al., 2017). This instrument was validated among individuals with advanced cancer and demonstrated high internal consistency (Cronbach's α \>.90) and highly correlated to HRQol (p=.05). The instrument consists of 11 items, utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).
Time frame
Change in baseline perception of treatment experience at 3 months3
Change in Patient Health Questionnaire (PHQ) 4
The Patient Health Questionnaire-4 (PHQ-4) is a 4-item inventory rated on a 4-point Likert-type scale. Its items are drawn from the first two items of the 'Generalized Anxiety Disorder-7 scale' (GAD-7) and the 'Patient Health Questionnaire-8' (PHQ-8). Its purpose is to allow for very brief and accurate measurement of depression and anxiety.
Time frame
Change in baseline perception of treatment experience at 3 months4
Change in Patient Reported Outcomes (PRO)-Common Terminology for Clinically Adverse Events (CTCAE) Blurry Vision Severity and Interference items
The PRO-CTCAE is a validated bank of 124 items representing patient experience of frequency, severity, interference, amount, and presence/absence of 78 symptomatic toxicities from the CTCAE. Responses are scored from 0 (absent) to 4 (severe/very much). We will administer 2 PRO-CTCAE instruments for: severity and interference of blurred vision.
Time frame
Change in baseline perception of treatment experience at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov