Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04589286
• Other study ID #: 202511
• Secondary ID: NCI-2020-08100
• Status: Completed
• Phase: N/A
• Start date: December 29, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Stem Cell Transplant

Intervention

Behavioral:
• Pack Health's Digital Life Coaching (DLC)
Pack Health smartphone-based DLC platform

Other:
• Electronic Handouts
Generic wellness-related electronic handouts

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Society of Clinical Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)	Proportions of patients with >=1 B/Z prescription versus <1 B/Z prescriptions will be compared between arms using chi-square analyses. Participants will be stratified on B/Z usage over time into 3 groups arms based on B/Z-naïve status (i.e., no B/Z usage at time of study enrollment), baseline psychosocial distress, defined as an National Comprehensive Caner Network (NCCN) Distress Thermometer (DT) score of 4 or higher, and baseline insomnia, defined as a Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance short form (SF) 4 item (4a) standardized score of 57 or higher.	Up to 6 months
Primary	Estimate change in B/Z usage	Estimations or differences in changes over time by study group will be performed via a post-estimation test using one-sided t-tests at each assessment. To control the family wise error rate at alpha level of 0.05, the Bonferroni method will be used.	Up to 6 months
Primary	Number of participants with a missing Patient Reported Outcome Measurement Information System (PROMIS) Global Health (GH) assessment	Sensitivity analyses for missing data will be performed on participants with missing PROMIS Global Health assessments	Up to 6 months
Primary	Number of participants with a missing NCCN Distress Thermometer (DT) assessment	Sensitivity analyses for missing data will be performed on participants with missing NCCN DT Assessments	Up to 6 months
Primary	Number of participants with a missing PROMIS Sleep Disturbance SF-4a inventory	Sensitivity analyses for missing data will be performed on participants with missing PROMIS Sleep Disturbance SF-4a inventories.	Up to 6 months
Secondary	Change in PROMIS Global Health (GH) Scale Scores	This 10-item inventory is part of the PROMIS series to assess quality of life (QOL) with item scores ranging from 1 to 5. Raw PROMIS scores will be transformed to T-score metrics to reflect a population mean of 50 and a standard deviation of 10. Among cancer patients, a T-score change of 5 points on any PROMIS inventory is generally considered to be clinically meaningful	Up to 6 months
Secondary	Change in NCCN Distress Thermometer (DT) Scores	This single-item inventory uses an analog graphic to allow patients to assess their overall distress with a score range of 0 (no distress) to 10 (extreme distress). A score of 4 or higher to differentiate clinically significant distress.	Up to 6 months
Secondary	Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores	The PROMIS Sleep Disturbance SF-4a inventory will be used to assess quality of sleep, with item scores ranging from 1 to 5. Raw PROMIS scores will subsequently be transformed to T-score metrics to reflect a population mean of 50 and standard deviation of 10. As validated in a previous study of cancer patients, a PROMIS Sleep Disturbance score of 57 or higher will be defined as insomnia.	Up to 6 months