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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-04166 | Other Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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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).
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:
Exploratory Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pack Health's digital life coaching (DLC) | Experimental | Access to the DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants displaying ongoing engagement with DLC | 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 | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Median PRO Measurement Information System (PROMIS) Global Health (GH) Score | 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. |
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Inclusion Criteria:
Confirmed diagnosis of one of the following (all referred to as MM in this protocol):
Planned receipt of autologous HCT at our institution
Age ≥ 18, as life coaches employed by the DLC vendor are not currently trained to work with pediatric patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rahul Banerjee, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35039279 | Derived | 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. |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Up to 16 weeks |
| Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score | 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. | Up to 16 weeks |
| Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score | 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 | Up to 16 weeks |
| Median Participant Satisfaction Score | 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?" | Up to 16 weeks |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |