- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04589286
Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation
Phase II Study of Digital Life Coaching in Multiple Myeloma Patients Undergoing Stem Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, Phase II randomized study of MM patients comparing 16 weeks of DLC access versus quasi-usual care (quasi-usual because both arms will receive generic wellness-related electronic handouts alongside requests for patient-reported outcome (PRO) assessments).
Primary Objective:
To evaluate DLC's impact on B/Z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or CINV)
Secondary Objectives:
- To evaluate DLC's impact on patient-reported general quality of life every 1-2 weeks
- To evaluate DLC's impact on patient-reported psychosocial distress every 1-2 weeks
- To evaluate DLC's impact on patient-reported insomnia every 1-2 weeks
Exploratory Objectives:
- To explore DLC's impact on rates of communications between patients and their treatment teams
- To explore DLC's impact on clinical outcomes
Participants may continue study treatment (DLC platform access) for 16 weeks from the time of initiating treatment. Participants will not be contacted by the DLC platform vendor after this point. Patients will be followed up at Day +101 after SCT, corresponding to approximately 3 months after SCT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Confirmed diagnosis of one of the following (all referred to as multiple myeloma (MM) for the purposes of this protocol):
- Multiple myeloma (ICD-10 code: C90.0)
- Extramedullary plasmacytoma (ICD-10 code: C90.2)
Planned receipt of autologous stem cell transplantation (SCT) at University of California, San Francisco (UCSF)
- Patients undergoing outpatient SCT will be eligible
- Patients who received chemomobilization will be eligible
- Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document
Exclusion Criteria:
- Age < 18 years
- SCT as salvage therapy
- Patient-assessed lack of sufficient English proficiency
- Lack of ownership of a personal smartphone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pack Health's Digital Life Coaching (DLC)
Participants will receive 16 weeks of access to a trained human life coach employed by Pack Health.
Coaches will communicate via phone calls, text messages, emails, and links to web-based Pack Health resources plus the addition of generic wellness-related electronic handouts at the time of each email reminder for participant-reported outcome (PRO) assessments
|
Pack Health smartphone-based DLC platform
Other Names:
Generic wellness-related electronic handouts
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Active Comparator: Quasi-usual care control arm
Participants will receive usual supportive care for stem cell transplantation plus the addition of generic wellness-related electronic handouts at the time of each email reminder for participant-reported outcome (PRO) assessments
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Generic wellness-related electronic handouts
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)
Time Frame: Up to 6 months
|
Proportions of patients with >=1 B/Z prescription versus <1 B/Z prescriptions will be compared between arms using chi-square analyses.
Participants will be stratified on B/Z usage over time into 3 groups arms based on B/Z-naïve status (i.e., no B/Z usage at time of study enrollment), baseline psychosocial distress, defined as an National Comprehensive Caner Network (NCCN) Distress Thermometer (DT) score of 4 or higher, and baseline insomnia, defined as a Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form (SF) 4 item (4a) standardized score of 57 or higher.
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Up to 6 months
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Estimate change in B/Z usage
Time Frame: Up to 6 months
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Estimations or differences in changes over time by study group will be performed via a post-estimation test using one-sided t-tests at each assessment.
To control the family wise error rate at alpha level of 0.05, the Bonferroni method will be used.
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Up to 6 months
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Number of participants with a missing Patient Reported Outcome Measurement Information System (PROMIS) Global Health (GH) assessment
Time Frame: Up to 6 months
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Sensitivity analyses for missing data will be performed on participants with missing PROMIS Global Health assessments
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Up to 6 months
|
Number of participants with a missing NCCN Distress Thermometer (DT) assessment
Time Frame: Up to 6 months
|
Sensitivity analyses for missing data will be performed on participants with missing NCCN DT Assessments
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Up to 6 months
|
Number of participants with a missing PROMIS Sleep Disturbance SF-4a inventory
Time Frame: Up to 6 months
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Sensitivity analyses for missing data will be performed on participants with missing PROMIS Sleep Disturbance SF-4a inventories.
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Up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PROMIS Global Health (GH) Scale Scores
Time Frame: Up to 6 months
|
This 10-item inventory is part of the PROMIS series to assess quality of life (QOL) with item scores ranging from 1 to 5. Raw PROMIS scores will be transformed to T-score metrics to reflect a population mean of 50 and a standard deviation of 10.
Among cancer patients, a T-score change of 5 points on any PROMIS inventory is generally considered to be clinically meaningful
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Up to 6 months
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Change in NCCN Distress Thermometer (DT) Scores
Time Frame: Up to 6 months
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This single-item inventory uses an analog graphic to allow patients to assess their overall distress with a score range of 0 (no distress) to 10 (extreme distress).
A score of 4 or higher to differentiate clinically significant distress.
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Up to 6 months
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Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores
Time Frame: Up to 6 months
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The PROMIS Sleep Disturbance SF-4a inventory will be used to assess quality of sleep, with item scores ranging from 1 to 5. Raw PROMIS scores will subsequently be transformed to T-score metrics to reflect a population mean of 50 and standard deviation of 10.
As validated in a previous study of cancer patients, a PROMIS Sleep Disturbance score of 57 or higher will be defined as insomnia.
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Up to 6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rahul Banerjee, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- 202511
- NCI-2020-08100 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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