NCT04432818

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable multiple-myeloma

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

9 months

First QC Date

June 11, 2020

Last Update Submit

June 1, 2021

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaDigital life coachingHematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Number of participants displaying ongoing engagement with DLC

    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 Outcomes (4)

  • Median PRO Measurement Information System (PROMIS) Global Health (GH) Score

    Up to 16 weeks

  • Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score

    Up to 16 weeks

  • Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score

    Up to 16 weeks

  • Median Participant Satisfaction Score

    Up to 16 weeks

Study Arms (1)

Pack Health's digital life coaching (DLC)

EXPERIMENTAL

Access to the DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up

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

Interventions

Pack Health's digital life coaching (DLC)BEHAVIORAL

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

Pack Health's digital life coaching (DLC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Banerjee R, Huang CY, Dunn L, Knoche J, Ryan C, Brassil K, Jackson L, Patel D, Lo M, Arora S, Wong SW, Wolf J, Martin Iii T, Dhruva A, Shah N. Digital Life Coaching During Stem Cell Transplantation: Development and Usability Study. JMIR Form Res. 2022 Mar 4;6(3):e33701. doi: 10.2196/33701.

    PMID: 35039279DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Rahul Banerjee, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 16, 2020

Study Start

May 20, 2020

Primary Completion

February 25, 2021

Study Completion

February 25, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)