Clinical trial NCT04589286: Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation
Official title: Phase II Study of Digital Life Coaching in Multiple Myeloma Patients Undergoing Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Stem Cell Transplant
Keywords: Digital life coaching
Multiple myeloma
Stem cell transplantation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
First posted: 2020-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)
timeFrame: Up to 6 months
measure: Estimate change in B/Z usage
timeFrame: Up to 6 months
measure: Number of participants with a missing Patient Reported Outcome Measurement Information System (PROMIS) Global Health (GH) assessment
timeFrame: Up to 6 months
measure: Number of participants with a missing NCCN Distress Thermometer (DT) assessment
timeFrame: Up to 6 months
measure: Number of participants with a missing PROMIS Sleep Disturbance SF-4a inventory
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in PROMIS Global Health (GH) Scale Scores
timeFrame: Up to 6 months
measure: Change in NCCN Distress Thermometer (DT) Scores
timeFrame: Up to 6 months
measure: Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Rahul Banerjee, MD
role: PRINCIPAL_INVESTIGATOR
References: