NCT04589286

Brief Summary

Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. We have found a 56% relative increase in the use of high-risk benzodiazepine and Z-class (B/Z) drugs for anxiety and insomnia among MM patients during this period. Digital life coaching (DLC), whereby trained coaches work longitudinally with patients through phone calls and text messages to accomplish personal goals, may be able to target anxiety and insomnia in a more integrative manner. This study will investigate whether peri-SCT DLC can lower B/Z usage and improve patient-reported well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-myeloma

Timeline
Completed

Started Dec 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 29, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

October 8, 2020

Last Update Submit

July 19, 2023

Conditions

Multiple MyelomaStem Cell Transplant

Keywords

Digital life coachingMultiple myelomaStem cell transplantation

Outcome Measures

Primary Outcomes (5)

  • Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)

    Proportions of patients with \>=1 B/Z prescription versus \<1 B/Z prescriptions will be compared between arms using chi-square analyses. Participants will be stratified on B/Z usage over time into 3 groups arms based on B/Z-naïve status (i.e., no B/Z usage at time of study enrollment), baseline psychosocial distress, defined as an National Comprehensive Caner Network (NCCN) Distress Thermometer (DT) score of 4 or higher, and baseline insomnia, defined as a Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form (SF) 4 item (4a) standardized score of 57 or higher.

    Up to 6 months

  • Estimate change in B/Z usage

    Estimations or differences in changes over time by study group will be performed via a post-estimation test using one-sided t-tests at each assessment. To control the family wise error rate at alpha level of 0.05, the Bonferroni method will be used.

    Up to 6 months

  • Number of participants with a missing Patient Reported Outcome Measurement Information System (PROMIS) Global Health (GH) assessment

    Sensitivity analyses for missing data will be performed on participants with missing PROMIS Global Health assessments

    Up to 6 months

  • Number of participants with a missing NCCN Distress Thermometer (DT) assessment

    Sensitivity analyses for missing data will be performed on participants with missing NCCN DT Assessments

    Up to 6 months

  • Number of participants with a missing PROMIS Sleep Disturbance SF-4a inventory

    Sensitivity analyses for missing data will be performed on participants with missing PROMIS Sleep Disturbance SF-4a inventories.

    Up to 6 months

Secondary Outcomes (3)

  • Change in PROMIS Global Health (GH) Scale Scores

    Up to 6 months

  • Change in NCCN Distress Thermometer (DT) Scores

    Up to 6 months

  • Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores

    Up to 6 months

Study Arms (2)

Pack Health's Digital Life Coaching (DLC)

EXPERIMENTAL

Participants will receive 16 weeks of access to a trained human life coach employed by Pack Health. Coaches will communicate via phone calls, text messages, emails, and links to web-based Pack Health resources plus the addition of generic wellness-related electronic handouts at the time of each email reminder for participant-reported outcome (PRO) assessments

Behavioral: Pack Health's Digital Life Coaching (DLC)Other: Electronic Handouts

Quasi-usual care control arm

ACTIVE COMPARATOR

Participants will receive usual supportive care for stem cell transplantation plus the addition of generic wellness-related electronic handouts at the time of each email reminder for participant-reported outcome (PRO) assessments

Other: Electronic Handouts

Interventions

Pack Health's Digital Life Coaching (DLC)BEHAVIORAL

Pack Health smartphone-based DLC platform

Also known as: DLC
Pack Health's Digital Life Coaching (DLC)
Electronic HandoutsOTHER

Generic wellness-related electronic handouts

Pack Health's Digital Life Coaching (DLC)Quasi-usual care control arm

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 multiple myeloma (MM) for the purposes of this protocol):
  • Multiple myeloma (ICD-10 code: C90.0)
  • Extramedullary plasmacytoma (ICD-10 code: C90.2)
  • Planned receipt of autologous stem cell transplantation (SCT) at University of California, San Francisco (UCSF)
  • Patients undergoing outpatient SCT will be eligible
  • Patients who received chemomobilization will be eligible
  • Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document

You may not qualify if:

  • Age \< 18 years
  • SCT as salvage therapy
  • Patient-assessed lack of sufficient English proficiency
  • Lack of ownership of a personal smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

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
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 19, 2020

Study Start

December 29, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)