Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation

NCT ID: NCT04589286

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-29
• Study Completion Date: 2023-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pack Health's Digital Life Coaching (DLC)

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

Group Type: EXPERIMENTAL

Pack Health's Digital Life Coaching (DLC)

Intervention Type: BEHAVIORAL

Pack Health smartphone-based DLC platform

Electronic Handouts

Intervention Type: OTHER

Generic wellness-related electronic handouts

Quasi-usual care control arm

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

Group Type: ACTIVE_COMPARATOR

Electronic Handouts

Intervention Type: OTHER

Generic wellness-related electronic handouts

Interventions

Pack Health's Digital Life Coaching (DLC)

Pack Health smartphone-based DLC platform

Intervention Type: BEHAVIORAL

Electronic Handouts

Generic wellness-related electronic handouts

Intervention Type: OTHER

Other Intervention Names

DLC

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Clinical Oncology

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rahul Banerjee, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

NCI-2020-08100

Identifier Type: REGISTRY

Identifier Source: secondary_id

202511

Identifier Type: -

Identifier Source: org_study_id