Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04432818
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2020-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Life Coaching for Myeloma Patients Undergoing Transplantation
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Digital Life Coaching in Multiple Myeloma Patients Undergoing Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the first study of digital life coaching (DLC) to engage patients during the peri-HCT period that is punctuated by intensive life changes. DLC may circumvent these limitations by combining the integrative cross-dimensional nature of life coaching with the advantages of mobile health technology. The purpose of this study is to evaluate whether ongoing participant engagement with a DLC platform is feasible for multiple myeloma (MM) patients actively undergoing hematopoietic stem cell transplantation (HCT).
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-04166 | OTHER | NCI Clinical Trials Reporting Program (CTRP) | View |