Multiple MyelomaNCT04589286
Randomized Study of Digital Life Coaching in Myeloma Patients Undergoing Transplantation
A study testing Pack Health's Digital Life Coaching (DLC) and Electronic Handouts in people with Multiple Myeloma and Stem Cell Transplant, run by University of California, San Francisco at 1 site in United States.
Trial summary
Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Stem Cell Transplant
- What is being tested?
- Pack Health's Digital Life Coaching (DLC) and Electronic Handouts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of one of the following (all referred to as multiple myeloma (MM) for the purposes of this protocol):
- Multiple myeloma (ICD-10 code: C90.0)
- Extramedullary plasmacytoma (ICD-10 code: C90.2)
- Planned receipt of autologous stem cell transplantation (SCT) at University of California, San Francisco (UCSF)
- Patients undergoing outpatient SCT will be eligible
- Patients who received chemomobilization will be eligible
- Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document
Who cannot join
- Age < 18 years
- SCT as salvage therapy
- Patient-assessed lack of sufficient English proficiency
- Lack of ownership of a personal smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Phase II Study of Digital Life Coaching in Multiple Myeloma Patients Undergoing Stem Cell Transplantation
Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. We have found a 56% relative increase in the use of high-risk benzodiazepine and Z-class (B/Z) drugs for anxiety and insomnia among MM patients during this period. Digital life coaching (DLC), whereby trained coaches work longitudinally with patients through phone calls and text messages to accomplish personal goals, may be able to target anxiety and insomnia in a more integrative manner. This study will investigate whether peri-SCT DLC can lower B/Z usage and improve patient-reported well-being.
Read the detailed description
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).
Primary Objective:
To evaluate DLC's impact on B/Z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or CINV)
Secondary Objectives:
- 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
Exploratory Objectives:
- 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.
- Conditions
- Multiple Myeloma, Stem Cell Transplant
- Being tested
- Pack Health's Digital Life Coaching (DLC), Electronic Handouts
- Keywords
- Digital life coaching, Multiple myeloma, Stem cell transplantation
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pack Health's Digital Life Coaching (DLC)Behavioural
Also called DLC
Pack Health smartphone-based DLC platform
Electronic HandoutsOther
Generic wellness-related electronic handouts
| Study group | Role | What they receive |
|---|---|---|
| Pack Health's Digital Life Coaching (DLC) | Experimental | 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 Receives: Behavioral: Pack Health's Digital Life Coaching (DLC); Other: Electronic Handouts |
| Quasi-usual care control arm | Active comparator | 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 Receives: Other: Electronic Handouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions)
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.
Measured: Up to 6 months
Estimate change in B/Z usage
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.
Measured: Up to 6 months
Number of participants with a missing Patient Reported Outcome Measurement Information System (PROMIS) Global Health (GH) assessment
Sensitivity analyses for missing data will be performed on participants with missing PROMIS Global Health assessments
Measured: Up to 6 months
Number of participants with a missing NCCN Distress Thermometer (DT) assessment
Sensitivity analyses for missing data will be performed on participants with missing NCCN DT Assessments
Measured: Up to 6 months
Number of participants with a missing PROMIS Sleep Disturbance SF-4a inventory
Sensitivity analyses for missing data will be performed on participants with missing PROMIS Sleep Disturbance SF-4a inventories.
Measured: Up to 6 months
Secondary outcomes (3)
Change in PROMIS Global Health (GH) Scale Scores
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
Measured: Up to 6 months
Change in NCCN Distress Thermometer (DT) Scores
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.
Measured: Up to 6 months
Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start29 Dec 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Sponsor
- Investigators
- Rahul Banerjee, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589286
- Sponsor's protocol ID
- 202511
- Other IDs
- NCI-2020-08100
- Status last verified
- Jul 2023
- First submitted
- 8 Oct 2020
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Digital Life Coaching in Multiple Myeloma Patients Undergoing Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04589286
- Acronym / sponsor ID
- 202511
- Conditions
- Multiple Myeloma, Stem Cell Transplant
- Keywords
- Digital life coaching, Multiple myeloma, Stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autologous stem cell transplantation (SCT) is the standard of care for fit multiple myeloma (MM) patients; however, the first 100 days after SCT are marked by extensive life disruptions. We have found a 56% relative increase in the use of high-risk benzodiazepine and Z-class (B/Z) drugs for anxiety and insomnia among MM patients during this period. Digital life coaching (DLC), whereby trained coaches work longitudinally with patients through phone calls and text messages to accomplish personal goals, may be able to target anxiety and insomnia in a more integrative manner. This study will investigate whether peri-SCT DLC can lower B/Z usage and improve patient-reported well-being.
Detailed description
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).
Primary Objective:
To evaluate DLC's impact on B/Z drug usage (excluding lorazepam prescribed for chemotherapy-induced nausea/vomiting, or CINV)
Secondary Objectives:
- 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
Exploratory Objectives:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pack Health's Digital Life Coaching (DLC) | Experimental | Behavioral: Pack Health's Digital Life Coaching (DLC), Other: Electronic HandoutsParticipants 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 |
| Quasi-usual care control arm | Active comparator | Other: Electronic HandoutsParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of one of the following (all referred to as multiple myeloma (MM) for the purposes of this protocol):
- Planned receipt of autologous stem cell transplantation (SCT) at University of California, San Francisco (UCSF)
- Ability to understand a written informed consent form (ICF) document, and the willingness to sign the ICF document
Key exclusion criteria (4 listed)
- Age < 18 years
- SCT as salvage therapy
- Patient-assessed lack of sufficient English proficiency
- Lack of ownership of a personal smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pack Health's Digital Life Coaching (DLC)Also: DLCPack Health smartphone-based DLC platform | Behavioural | Pack Health's Digital Life Coaching (DLC) |
| Electronic HandoutsGeneric wellness-related electronic handouts | Other | Pack Health's Digital Life Coaching (DLC), Quasi-usual care control arm |
Primary outcome
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.
3 secondary outcomes
Change in PROMIS Global Health (GH) Scale Scores
Time frame: Up to 6 months
Change in NCCN Distress Thermometer (DT) Scores
Time frame: Up to 6 months
Change in PROMIS 4-item Sleep Disturbance Short Form (SF-4a) Scores
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Banerjee, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pack Health's Digital Life Coaching (DLC) and Electronic Handouts in people with Multiple Myeloma and Stem Cell Transplant, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of patients with >=1 benzodiazepine and Z-class (B/Z) prescriptions (versus < 1 B/Z prescriptions) (time frame: Up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.