NCT04589286

Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Myeloma
• Stem Cell Transplant

Interventions

Type	Name	Description
BEHAVIORAL	Pack Health's Digital Life Coaching (DLC)	Pack Health smartphone-based DLC platform
OTHER	Electronic Handouts	Generic wellness-related electronic handouts

Timeline

• Start date: 2020-12-29
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-10-19
• Last updated: 2023-07-20

Locations

1 site across 1 country: United States