- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432818
Digital Life Coaching for Myeloma Patients Undergoing Transplantation
Digital Life Coaching in Multiple Myeloma Patients Undergoing Hematopoietic Stem Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will receive unlimited access to Pack Health's DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up. Participants will engage with Pack Health's DLC platform and complete quality of life assessments for 16 weeks beginning from enrollment. At the conclusion of the treatment period, participants will be asked to rate their satisfaction with the DLC platform
Primary Objective:
To evaluate the rate of ongoing participant engagement with a DLC platform during the study period
Secondary Objectives:
- To assess quality of life among participants during the study period
- To assess psychosocial distress among participants during the study period
- To assess sleep disturbances among participants during the study period
- To assess participant satisfaction with the DLC platform at the end of the study period
Exploratory Objectives:
- To assess benzodiazepine and zolpidem-class drug usage for anxiety or insomnia among participants during the study period
- To assess communications with treatment teams among participants during the study period
- To assess 100-day clinical outcomes among participants at the end of the study period
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Confirmed diagnosis of one of the following (all referred to as MM in this protocol):
- Multiple myeloma (ICD-10 code: C90.0)
- Extramedullary plasmacytoma (ICD-10 code: C90.2)
Planned receipt of autologous HCT at our institution
- Patients undergoing outpatient HCT will be eligible
- Patients who received chemomobilization will be eligible
- Age ≥ 18, as life coaches employed by the DLC vendor are not currently trained to work with pediatric patients
Exclusion Criteria:
- Prior autologous HCT for any indication
- Physician-assessed lack of sufficient English proficiency
- Lack of ownership of a personal smartphone
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pack Health's digital life coaching (DLC)
Access to the DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up
|
Pack Health smartphone-based DLC platform will be provided for 16-week subscription which allows unlimited bidirectional communication between enrolled participants and their life coach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants displaying ongoing engagement with DLC
Time Frame: Up to 16 weeks
|
Ongoing participant engagement is defined as at least 4 or more participant-initiated interactions with the DLC platform, including at least 1 interaction in each of four 4-week study sub-periods
|
Up to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median PRO Measurement Information System (PROMIS) Global Health (GH) Score
Time Frame: Up to 16 weeks
|
The PROMIS GH instrument v1.2 will be used to assess quality of life.
This 10-item inventory with scores ranging from 1 to 5 with higher scores indicating a a greater quality of life.
Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and 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.
|
Up to 16 weeks
|
Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score
Time Frame: Up to 16 weeks
|
The NCCN DT will be used to assess psychosocial distress.
This single-item inventory uses a graphic of a thermometer to allow patients to assess their overall distress on a scale of 0=No Distress to 10= Extreme distress.
The NCCN considers a cutoff score of 4 to differentiate clinically significant distress.
|
Up to 16 weeks
|
Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score
Time Frame: Up to 16 weeks
|
The PROMIS SD SF 4a inventory will be used to measure overall sleep disturbance in past 7 days.
This assessment consists of 4 items which measure sleep quality and sleep disturbances using a 5 point likert scale ranging in value from 1 to 5 with higher scores indicating greater sleep quality.
Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and 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
|
Up to 16 weeks
|
Median Participant Satisfaction Score
Time Frame: Up to 16 weeks
|
Participants will be asked to provide a response, on a scale from 0 (not at all likely) to 10 (extremely likely), to the following single question: "How likely are you to recommend this life coaching tool to other patients undergoing stem cell transplantation?"
|
Up to 16 weeks
|
Collaborators and Investigators
Publications and helpful links
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
- 20252
- NCI-2020-04166 (Other 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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