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Completed

NCT Number: NCT04589286

Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation

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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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Stem Cell Transplant Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pack Health's Digital Life Coaching (DLC)

Behavioral

Pack Health smartphone-based DLC platform

Other names: DLC

Electronic Handouts

Other

Generic wellness-related electronic handouts

Primary outcomes

  1. Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)

    Time frame: Up to 6 months

    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.

  2. Estimate change in B/Z usage

    Time frame: Up to 6 months

    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.

  3. Number of participants with a missing Patient Reported Outcome Measurement Information System (PROMIS) Global Health (GH) assessment

    Time frame: Up to 6 months

    Sensitivity analyses for missing data will be performed on participants with missing PROMIS Global Health assessments

  4. Number of participants with a missing NCCN Distress Thermometer (DT) assessment

    Time frame: Up to 6 months

    Sensitivity analyses for missing data will be performed on participants with missing NCCN DT Assessments

  5. Number of participants with a missing PROMIS Sleep Disturbance SF-4a inventory

    Time frame: Up to 6 months

    Sensitivity analyses for missing data will be performed on participants with missing PROMIS Sleep Disturbance SF-4a inventories.

Secondary outcomes

  1. Change in PROMIS Global Health (GH) Scale Scores

    Time frame: Up to 6 months

    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

  2. Change in NCCN Distress Thermometer (DT) Scores

    Time frame: Up to 6 months

    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.

  3. Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Society of Clinical Oncology

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2020
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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