Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Rahul Banerjee, MD
Photo of Rahul Banerjee
Rahul Banerjee

Description

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.

Official Title

Phase II Study of Digital Life Coaching in Multiple Myeloma Patients Undergoing Stem Cell Transplantation

Details

This is a single-center, Phase II randomized study of MM patients comparing 16 weeks of DLC access versus quasi-usual care (quasi-usual because both arms will receive generic wellness-related electronic handouts alongside requests for patient-reported outcome (PRO) assessments). Primary Objective: To evaluate DLC's impact on B/Z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or CINV) Secondary Objectives: 1. To evaluate DLC's impact on patient-reported general quality of life every 1-2 weeks 2. To evaluate DLC's impact on patient-reported psychosocial distress every 1-2 weeks 3. To evaluate DLC's impact on patient-reported insomnia every 1-2 weeks Exploratory Objectives: 1. To explore DLC's impact on rates of communications between patients and their treatment teams 2. To explore DLC's impact on clinical outcomes Participants may continue study treatment (DLC platform access) for 16 weeks from the time of initiating treatment. Participants will not be contacted by the DLC platform vendor after this point. Patients will be followed up at Day +101 after SCT, corresponding to approximately 3 months after SCT.

Keywords

Multiple Myeloma Stem Cell Transplant Digital life coaching Stem cell transplantation Neoplasms, Plasma Cell Pack Health's Digital Life Coaching (DLC) Electronic Handouts

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join if...

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

Location

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

Lead Scientist at UCSF

  • Rahul Banerjee, MD
    Clinical Fellow, Medicine. Authored (or co-authored) 19 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04589286
Study Type
Interventional
Last Updated