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OpenTrials
Completed

NCT Number: NCT04432818

Digital Life Coaching for Myeloma Patients Undergoing Transplantation

This is the first study of digital life coaching (DLC) to engage patients during the peri-HCT period that is punctuated by intensive life changes. DLC may circumvent these limitations by combining the integrative cross-dimensional nature of life coaching with the advantages of mobile health technology. The purpose of this study is to evaluate whether ongoing participant engagement with a DLC platform is feasible for multiple myeloma (MM) patients actively undergoing hematopoietic stem cell transplantation (HCT).

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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 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

Participants will receive unlimited access to Pack Health's DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up. Participants will engage with Pack Health's DLC platform and complete quality of life assessments for 16 weeks beginning from enrollment. At the conclusion of the treatment period, participants will be asked to rate their satisfaction with the DLC platform

Primary Objective:

To evaluate the rate of ongoing participant engagement with a DLC platform during the study period

Secondary Objectives:

  • To assess quality of life among participants during the study period
  • To assess psychosocial distress among participants during the study period
  • To assess sleep disturbances among participants during the study period
  • To assess participant satisfaction with the DLC platform at the end of the study period

Exploratory Objectives:

  • To assess benzodiazepine and zolpidem-class drug usage for anxiety or insomnia among participants during the study period
  • To assess communications with treatment teams among participants during the study period
  • To assess 100-day clinical outcomes among participants at the end of the study period

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 MM in this protocol):
  • Multiple myeloma (ICD-10 code: C90.0)
  • Extramedullary plasmacytoma (ICD-10 code: C90.2)
  • Planned receipt of autologous HCT at our institution
  • Patients undergoing outpatient HCT will be eligible
  • Patients who received chemomobilization will be eligible
  • Age ≥ 18, as life coaches employed by the DLC vendor are not currently trained to work with pediatric patients

Exclusion criteria

  • Prior autologous HCT for any indication
  • Physician-assessed lack of sufficient English proficiency
  • Lack of ownership of a personal smartphone
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures

Treatment and study plan

Pack Health's Digital Life Coaching (DLC)

Behavioral

Pack Health smartphone-based DLC platform will be provided for 16-week subscription which allows unlimited bidirectional communication between enrolled participants and their life coach

Primary outcomes

  1. Number of participants displaying ongoing engagement with DLC

    Time frame: Up to 16 weeks

    Ongoing participant engagement is defined as at least 4 or more participant-initiated interactions with the DLC platform, including at least 1 interaction in each of four 4-week study sub-periods

Secondary outcomes

  1. Median PRO Measurement Information System (PROMIS) Global Health (GH) Score

    Time frame: Up to 16 weeks

    The PROMIS GH instrument v1.2 will be used to assess quality of life. This 10-item inventory with scores ranging from 1 to 5 with higher scores indicating a a greater quality of life. Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and 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. Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score

    Time frame: Up to 16 weeks

    The NCCN DT will be used to assess psychosocial distress. This single-item inventory uses a graphic of a thermometer to allow patients to assess their overall distress on a scale of 0=No Distress to 10= Extreme distress. The NCCN considers a cutoff score of 4 to differentiate clinically significant distress.

  3. Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score

    Time frame: Up to 16 weeks

    The PROMIS SD SF 4a inventory will be used to measure overall sleep disturbance in past 7 days. This assessment consists of 4 items which measure sleep quality and sleep disturbances using a 5 point likert scale ranging in value from 1 to 5 with higher scores indicating greater sleep quality. Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and 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

  4. Median Participant Satisfaction Score

    Time frame: Up to 16 weeks

    Participants will be asked to provide a response, on a scale from 0 (not at all likely) to 10 (extremely likely), to the following single question: "How likely are you to recommend this life coaching tool to other patients undergoing stem cell transplantation?"

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Digital Life Coaching in Multiple Myeloma Patients Undergoing Hematopoietic Stem Cell Transplantation

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2020
Registry last updated
Jun 4, 2021

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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