Multiple Myeloma Clinical Trial
Official title:
Evaluating Patient-Reported Outcomes and Wearable Data Among Individuals With Relapsed/Refractory Multiple Myeloma
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 or older 2. Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible. 3. 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). Exclusion Criteria: 1. 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) 2. Individuals who have previously participated in Pack Health digital health coaching 3. Physician-assessed lack of sufficient English proficiency 4. Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application 5. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures 6. Concurrent enrollment on a therapeutic study in R/R MM that precludes simultaneous enrollment onto our non-therapeutic study |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Pack Health | GlaxoSmithKline, University of Washington |
United States,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Change in baseline perception of treatment experience at 3 months | |
Other | Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) | A 30-item measure of quality of life across 5 domains, including physical, emotional, social, role and cognitive), 8 symptoms, and items assessing global health and financial toxicity. Recall over the past week is scored primarily on a 4-point scale ranging from "not at all" to "very much". The instrument may be administered either on paper or electronically. | Change in baseline perception of treatment experience at 3 months | |
Other | 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 a >.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). | Change in baseline perception of treatment experience at 3 months | |
Other | Change in Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20) | A 20-item measure of quality of life among individuals with multiple myeloma. It assesses a series of symptoms on a 4-point Likert scale ranging from 1 (Not at All) to 4 (Very Much). | Change in baseline perception of treatment experience at 3 months | |
Other | 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. | Change in baseline perception of treatment experience at 3 months | |
Other | 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. | Change in baseline perception of treatment experience at 3 months | |
Other | Physical Activity | Minutes of physical activity will be collected via Fitbits provided to study participants | From date of enrollment up to 3 months | |
Other | Physical Activity | Daily step count will be collected via Fitbits provided to study participants | From date of enrollment up to 3 months | |
Other | Digital Engagement | Duration of engagement with the digital health coaching platform | From date of enrollment up to 3 months | |
Other | Digital Engagement | Frequency of engagement with the digital health coaching platform | From date of enrollment up to 3 months | |
Other | Digital Engagement | Methods of engagement with the digital health coaching platform | From date of enrollment up to 3 months | |
Primary | 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 | At 3 months following the start of the coaching intervention | |
Secondary | 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". | Change in baseline perception of treatment experience at 3 months |
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