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Digital Life Coaching for Myeloma Patients Undergoing Transplantation

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

Multiple Myeloma

Treatments

Behavioral: Pack Health's digital life coaching (DLC)

Study type

Interventional

Funder types

Other

Identifiers

NCT04432818
NCI-2020-04166 (Other Identifier)
20252

Details and patient eligibility

About

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).

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

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

17 participants in 1 patient group

Pack Health's digital life coaching (DLC)
Experimental group
Description:
Access to the DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up
Treatment:
Behavioral: Pack Health's digital life coaching (DLC)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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