Clinical trial NCT04432818: Digital Life Coaching for Myeloma Patients Undergoing Transplantation
Official title: Digital Life Coaching in Multiple Myeloma Patients Undergoing Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Digital life coaching
Hematopoietic stem cell transplantation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants displaying ongoing engagement with DLC
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Median PRO Measurement Information System (PROMIS) Global Health (GH) Score
timeFrame: Up to 16 weeks
measure: Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score
timeFrame: Up to 16 weeks
measure: Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score
timeFrame: Up to 16 weeks
measure: Median Participant Satisfaction Score
timeFrame: Up to 16 weeks
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:
citation: Banerjee R, Huang CY, Dunn L, Knoche J, Ryan C, Brassil K, Jackson L, Patel D, Lo M, Arora S, Wong SW, Wolf J, Martin Iii T, Dhruva A, Shah N. Digital Life Coaching During Stem Cell Transplantation: Development and Usability Study. JMIR Form Res. 2022 Mar 4;6(3):e33701. doi: 10.2196/33701.