Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04589286|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : February 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Stem Cell Transplant||Behavioral: Pack Health's Digital Life Coaching (DLC) Other: Electronic Handouts||Not Applicable|
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).
To evaluate DLC's impact on B/Z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or CINV)
- 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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Study of Digital Life Coaching in Multiple Myeloma Patients Undergoing Stem Cell Transplantation|
|Actual Study Start Date :||December 29, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Pack Health's Digital Life Coaching (DLC)
Participants will receive 16 weeks of access to a trained human life coach employed by Pack Health. Coaches will communicate via phone calls, text messages, emails, and links to web-based Pack Health resources plus the addition of generic wellness-related electronic handouts at the time of each email reminder for participant-reported outcome (PRO) assessments
Behavioral: Pack Health's Digital Life Coaching (DLC)
Pack Health smartphone-based DLC platform
Other Name: DLC
Other: Electronic Handouts
Generic wellness-related electronic handouts
Active Comparator: Quasi-usual care control arm
Participants will receive usual supportive care for stem cell transplantation plus the addition of generic wellness-related electronic handouts at the time of each email reminder for participant-reported outcome (PRO) assessments
Other: Electronic Handouts
Generic wellness-related electronic handouts
- 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.
- 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.
- 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
- 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
- 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.
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589286
|Contact: Rahul Banerjee, MD||877-827-3222||Rahul.Banerjee@ucsf.edu|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Rahul Banerjee, MD Rahul.Bannerjee@ucsf.edu|
|Contact 877-827-3222 email@example.com|
|Principal Investigator: Rahul Banerjee, MD|
|Sub-Investigator: Nina Shah, MD|
|Principal Investigator:||Rahul Banerjee, MD||University of California, San Francisco|