Multiple Myeloma Clinical Trial

Digital Life Coaching for Myeloma Patients Undergoing Transplantation

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).

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Full 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

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Myeloma

Estimated Enrollment:

17

Study ID:

NCT04432818

Recruitment Status:

Completed

Sponsor:

University of California, San Francisco

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There is 1 Location for this study

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University of California, San Francisco
San Francisco California, 94143, United States

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

17

Study ID:

NCT04432818

Recruitment Status:

Completed

Sponsor:


University of California, San Francisco

How clear is this clinincal trial information?

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