Multiple Myeloma Clinical Trial

Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation

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.

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Full 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:

To evaluate DLC's impact on patient-reported general quality of life every 1-2 weeks
To evaluate DLC's impact on patient-reported psychosocial distress every 1-2 weeks
To evaluate DLC's impact on patient-reported insomnia every 1-2 weeks

Exploratory Objectives:

To explore DLC's impact on rates of communications between patients and their treatment teams
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.

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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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

60

Study ID:

NCT04589286

Recruitment Status:

Active, not recruiting

Sponsor:

University of California, San Francisco

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There is 1 Location for this study

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

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

60

Study ID:

NCT04589286

Recruitment Status:

Active, not recruiting

Sponsor:


University of California, San Francisco

How clear is this clinincal trial information?

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