Digital Health Coaching for Multiple Myeloma

Overseen By Jennifer Loftis, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pack Health

Must be taking: Proteasome inhibitors, Immunomodulatory drugs

Disqualifiers: Terminal illness, No smartphone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a digital health coaching program can assist individuals in managing life with relapsed or refractory multiple myeloma, a type of blood cancer. Participants will receive weekly phone support and educational materials and will use a Fitbit to track their activity. The study will evaluate the program's impact on quality of life, symptom management, and healthcare usage. Individuals who have begun at least a second round of treatment for multiple myeloma and have experience with certain medications may be suitable candidates. As an unphased study, this trial provides a unique opportunity to explore innovative support methods for enhancing daily life with multiple myeloma.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on digital health coaching rather than medication changes.

What prior data suggests that this digital health coaching program is safe for individuals with multiple myeloma?

Research shows that digital health coaching is generally easy for people to use. Studies have tested its simplicity and acceptability for patients, and so far, people find it helpful and manageable.

Regarding the Fitbit, studies have found it useful for tracking physical activity in patients with myeloma. People can use it comfortably without major issues. The Fitbit helps monitor health and predict outcomes, making it a valuable part of health management.

Both digital health coaching and the Fitbit involve minimal risk because they don't use medications or involve medical procedures. They are designed to support patients and gather information to improve care. Overall, research suggests that digital health coaching and the Fitbit are safe and useful tools for managing health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Health Coaching program for multiple myeloma because it offers a new, tech-savvy approach to patient care. Unlike traditional treatments that focus on chemotherapy and medications, this program leverages digital health tools to enhance patients' well-being and monitor their physical activity through a Fitbit device. By providing personalized health coaching and real-time activity tracking, this method aims to empower patients with more control over their health, potentially improving outcomes in a holistic and sustainable way.

What evidence suggests that this digital health coaching program is effective for multiple myeloma?

Research has shown that digital health coaching can enhance the quality of life for individuals with relapsed or refractory multiple myeloma. This trial features a single arm where all participants will engage in a 3-month digital health coaching program. Participants will also wear a Fitbit device daily to capture physical activity data. Studies have found that devices like Fitbits effectively track physical activity, which can help predict health outcomes in cancer patients. In four out of six studies, patients using these devices experienced positive effects. Combining coaching with wearable technology may simplify health management and progress tracking. ^{1 3 4 6 7}

Who Is on the Research Team?

Rahul Banerjee, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

Adults over 18 with relapsed or refractory multiple myeloma, who have undergone at least one prior treatment including a proteasome inhibitor or immunomodulatory drug. Not for those with less than 6 months to live, without smartphone access, insufficient English proficiency, or on conflicting R/R MM studies.

Inclusion Criteria

I have been diagnosed with multiple myeloma, and I may also have AL amyloidosis.

I am starting my second or later treatment for multiple myeloma and have previously been treated with a PI or IMiD.

Exclusion Criteria

Concurrent enrollment on a therapeutic study in R/R MM that precludes simultaneous enrollment onto our non-therapeutic study

You have been in Pack Health digital health coaching before.

Physician-assessed lack of sufficient English proficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Health Coaching Program

Participants are enrolled in a 3-month digital health coaching program, receiving weekly phone calls and learning materials via text or email. They will also wear a Fitbit device to capture physical activity data.

12 weeks

Weekly phone calls

Follow-up

Participants are monitored for changes in treatment experience, quality of life, and other outcomes after the digital health coaching program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Health Coaching Program
• Fitbit

Trial Overview The trial is testing a digital health coaching program that includes weekly phone calls and educational materials via text/email. Participants will also use a Fitbit to track activity levels. The focus is on the impact of this program on quality of life and healthcare management confidence.

How Is the Trial Designed?

Group I: Single Arm Cohort Receiving Digital Health Coaching Experimental Treatment 2 Interventions

All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.

Who Is Running the Clinical Trial?

Pack Health

Lead Sponsor

Trials

6

Recruited

1,100+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Published Research Related to This Trial

In a study involving 763 overweight participants using a mobile phone-based health coaching service for 4 months, participants lost an average of 3.23% of their total body weight, with 28.6% achieving a clinically significant weight loss of 5% or more.

Among participants with high blood pressure, nearly half (49.1%) improved their blood pressure by an entire hypertensive stage after 4 months of coaching, indicating that digital health coaching can effectively support both weight loss and blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Phone-Based Health Coaching Intervention for Weight Loss and Blood Pressure Reduction in a National Payer Population: A Retrospective Study. Mao, AY., Chen, C., Magana, C., et al.[2019]

A 3-week study involving 26 men with prostate cancer found that the Fitbit Zip was generally accepted, with participants finding it comfortable and easy to wear.

Participants expressed interest in sharing their fitness tracking data with healthcare providers, indicating potential for integrating such devices into clinical care to support physical activity and health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of Fitbit for physical activity tracking within clinical care among men with prostate cancer. Rosenberg, D., Kadokura, EA., Bouldin, ED., et al.[2022]

Personalized SMS coaching significantly improved the capabilities, opportunities, and relationships of physically inactive adults, with effect sizes ranging from 0.43 to 0.51, indicating its effectiveness in promoting behavior change.

The study highlighted the importance of the human connection between clients and fitness consultants, suggesting that this relationship enhances motivation and the overall success of digital health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Coaching via Texting for Behavior Change to Understand a Healthy Lifestyle Intervention in a Naturalistic Setting: Mixed Methods Study. Bäccman, C., Bergkvist, L., Wästlund, E.[2023]

Cancer survivors using wearable activity trackers, like Fitbits, have shown an increase in physical activity, which is important for reducing negative effects from cancer treatments and improving overall health outcomes.

The review identified 13 relevant studies, including 8 randomized controlled trials, indicating a need for further research to better understand how these devices can effectively promote physical activity and weight management in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of consumer wearable devices to promote physical activity among breast, prostate, and colorectal cancer survivors: a review of health intervention studies. Coughlin, SS., Caplan, LS., Stone, R.[2020]

Healthcare professionals play a crucial role in promoting patient access and adherence to digital therapeutics, as they can prescribe these interventions and monitor their use, which is essential for effective treatment.

To enhance the adoption of digital therapeutics, stakeholders should focus on educating healthcare professionals, simplifying prescription processes, and empowering patients, alongside implementing macro-level changes like better financial incentives and blended care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There's an app for that, but nobody's using it: Insights on improving patient access and adherence to digital therapeutics in Germany. Dahlhausen, F., Zinner, M., Bieske, L., et al.[2022]

Multiple myeloma (MM) patients experience significant health-related quality of life (HRQoL) challenges, particularly at diagnosis and relapse, highlighting the need for effective monitoring of their condition.

Digital health technologies, such as telemedicine and mobile health, have the potential to improve health outcomes for MM patients, but face barriers like limited access for older patients and a lack of integration with existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health for Patients With Multiple Myeloma: An Unmet Need. Jagannath, S., Mikhael, J., Nadeem, O., et al.[2021]

Wearable health devices, like activity trackers and mobile ECGs, have proven effective in various prevention strategies, helping to promote fitness, detect heart issues, and manage diabetes.

The future of mHealth looks promising with advancements in integrating diverse data and using AI-driven health coaches, which could enhance both individual health management and overall public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health and Preventive Medicine. Waalen, J.[2023]

Medical students using activity trackers combined with weekly email communication (Fitbit-Plus group) significantly increased their daily step count compared to those using only the trackers (Fitbit-Only group), with an average of 7429 steps versus 6483 steps over the academic year.

The Fitbit-Plus group also showed improvements in body composition, with overweight women experiencing a decrease in body fat percentage and overweight men gaining lean body mass, highlighting the effectiveness of combining behavioral challenges with activity tracking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. DiFrancisco-Donoghue, J., Jung, MK., Stangle, A., et al.[2022]

Blended-care behavior change interventions (BBCI) effectively promote weight loss, with participants losing an average of 6.55 kg over 12 months, based on data from 25,706 patients.

Coaching, self-monitoring, and self-management are key components that positively influence weight loss, while excessive appointments with dietitian coaches may hinder progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Intervention Elements Drive Weight Loss in Blended-Care Behavior Change Interventions? A Real-World Data Analysis with 25,706 Patients. Schirmann, F., Kanehl, P., Jones, L.[2022]

A 12-week eHealth exercise program for people with multiple myeloma was found to be safe and feasible, with no serious adverse events reported and a high adherence rate of 90%.

Participants experienced significant improvements in quality of life and physical fitness, with 96% reporting the program as beneficial and 89% satisfied with the delivery through the HEAL-Me app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a tailored and virtually supported home exercise program for people with multiple myeloma using a novel eHealth application. Purdy, GM., Venner, CP., Tandon, P., et al.[2022]

A study involving newly diagnosed multiple myeloma patients showed that a novel digital educational strategy significantly improved treatment adherence and quality of life compared to conventional education methods.

The digital strategy not only empowered patients and caregivers with better understanding and recall of treatment information but also facilitated quicker reintegration into daily activities, highlighting the importance of patient engagement in managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Digital Educational Strategy Improves Treatment Adherence and Quality of Life in Patients with Multiple Myeloma. Guio, J., Melo, A., Saldarriaga, MM., et al.[2023]

eHealth solutions for cancer therapy management have shown significant benefits, particularly in symptom monitoring, which is linked to improved survival rates for patients.

While there are many emerging eHealth applications, especially in physical activity support, the field of nutrition in oncology has fewer successful interventions, though eHealth for detecting malnutrition shows promise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized eHealth Support for Oncological Therapy Management. Schinköthe, T.[2020]

Wearable activity monitors are increasingly utilized in oncology trials to provide objective data on physical activity, with 41 trials identified, primarily involving cancer survivors and breast cancer patients.

These monitors can help assess daily activity levels, revealing that cancer survivors take between 4660 and 11,000 steps per day, while those undergoing treatment take 2885 to 8300 steps, indicating a need for further standardization in data collection and analysis to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable activity monitors in oncology trials: Current use of an emerging technology. Gresham, G., Schrack, J., Gresham, LM., et al.[2019]

The study aims to evaluate the effectiveness of a mobile app called Stay Strong, which tracks physical activity and weight in veterans, comparing the impact of the app alone versus the app combined with personalized health coaching over a year.

With 357 veterans enrolled, the trial will assess whether adding coaching features, such as tailored messaging and phone calls, enhances physical activity levels compared to using the app without coaching.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Effect of Adding Automated and Human Coaching to a Mobile Health Physical Activity App for Afghanistan and Iraq Veterans: Protocol for a Randomized Controlled Trial of the Stay Strong Intervention. Buis, LR., McCant, FA., Gierisch, JM., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05956457?term=Health%20Coaching&aggFilters=status:rec&country=United%20States&locStr=United%20States&viewType=Table&rank=8

PRO and Wearable Data Insights From Individuals With R ... This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM).

2. sparkcures.com sparkcures.com/trial/1740/NCT05956457

Multiple Myeloma Support + Trials This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM). This trial is ...

3. dana-farber.org dana-farber.org/clinical-trials/21-737

Comprehensive Outcomes for After Cancer Health (COACH) This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have

4. withpower.com withpower.com/trial/phase-multiple-myeloma-6-2023-21603

Digital Health Coaching for Multiple Myeloma This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05064787

Evaluating the Feasibility of a Digital Health Coaching ... The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05956457/pro-and-wearable-data-insights-from-individuals-with-r-r-multiple-myeloma

PRO and Wearable Data Insights From Individuals With R/R ... This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM).

7. themyelomaclinicaltrials.com themyelomaclinicaltrials.com/single-post/packhealth

Digital Health Coaching - Pack Health - Myeloma Clinical Trials The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, ...