Digital Life Coaching for Myeloma Patients Undergoing Transplantation

NCT ID: NCT04432818

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2021-02-25

Brief Summary

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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

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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

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pack Health's digital life coaching (DLC)

Access to the DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up

Group Type EXPERIMENTAL

Pack Health's digital life coaching (DLC)

Intervention Type 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

Interventions

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Pack Health's digital life coaching (DLC)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rahul Banerjee, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35039279 (View on PubMed)

Other Identifiers

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NCI-2020-04166

Identifier Type: OTHER

Identifier Source: secondary_id

20252

Identifier Type: -

Identifier Source: org_study_id

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