Remote Monitoring with Health-Coaching for Multiple Myeloma

Overseen By Clinical Trials Referral Office

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Proteasome inhibitors, Immunomodulatory agents, Anti-C38 antibodies

Disqualifiers: Under 65, No wi-fi, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based mindfulness and physical activity program, combined with phone health coaching, can reduce fatigue and improve quality of life for older adults with multiple myeloma, a type of blood cancer. Participants will engage in gentle exercises and breathing techniques monitored remotely, while also receiving weekly phone calls for support. Ideal candidates experience moderate or higher fatigue, are 65 or older, and are currently undergoing specific treatments for multiple myeloma. Internet access is necessary for participation in the program.

As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance well-being for others in the future.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on maintenance treatment with certain medications, so you may need to continue those.

What prior data suggests that this home-based mindfulness physical activity program with remote monitoring and health coaching is safe for older patients with multiple myeloma?

Research shows that home-based mindfulness and physical activity programs, monitored remotely, are generally safe and well-received by people with multiple myeloma. Past studies have found these programs practical and helpful for participants.

Participants usually engage in gentle activities like stretching, slow walking, and breathing exercises. These activities can be done at home, offering convenience and reducing stress, especially for older adults. Health coaching, which involves setting goals and receiving support over the phone, has also proven safe in similar studies.

Although detailed information on side effects in these specific trials isn't available, the low-impact and closely monitored nature of the activities suggests a low risk of harm. Overall, these programs aim to improve quality of life by reducing tiredness and encouraging safe physical activity for older adults with multiple myeloma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to managing multiple myeloma through a home-based mindfulness physical activity program that includes remote monitoring and health coaching. Unlike standard treatments such as chemotherapy, stem cell transplants, and targeted therapy, this program focuses on enhancing patients' quality of life and potentially improving outcomes by incorporating daily physical activities like flexibility exercises, slow walking, and breathing practices. The innovative use of remote monitoring technology allows for personalized feedback and progress tracking, while structured telephone-based coaching provides ongoing support and motivation. This holistic and patient-centered approach could offer a complementary strategy to traditional medical treatments, empowering patients to take an active role in their health management.

What evidence suggests that this home-based mindfulness physical activity program with remote monitoring and health coaching is effective for improving quality of life in older patients with multiple myeloma?

Research has shown that exercise can reduce tiredness and improve the quality of life in older cancer patients. Mindfulness activities, which focus on reducing stress and promoting relaxation, help with sleep, depression, anxiety, and cancer-related tiredness. Health coaching, where participants set goals and receive support from a coach, increases physical activity and improves quality of life. In this trial, participants will engage in a home-based mindfulness physical activity program with remote monitoring and structured telephone-based health coaching. This combination might reduce tiredness and improve the well-being of older patients with multiple myeloma. Early results suggest this comprehensive approach could be effective. ^{1 2 3 6 7}

Who Is on the Research Team?

Nadine H. Abdallah, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for older patients (65+) with multiple myeloma who've had at least one prior treatment and are now on maintenance therapy. They should be able to perform daily activities with minimal assistance, have moderate or higher fatigue levels, and must be English-speaking. Patients already receiving care at Mayo Clinic or elsewhere can join.

Inclusion Criteria

I have multiple myeloma and have been treated before, now on maintenance therapy.

You can understand and answer questions in English.

My average fatigue over the last week was more than 4 out of 10.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a home-based mindfulness physical activity program with remote monitoring and receive telephone health coaching for 12 weeks

12 weeks

Weekly telephone health coaching sessions

Follow-up

Participants are monitored for changes in fatigue and quality of life, including a qualitative interview at the end of the intervention

3 months

1 brief telephone interview

What Are the Treatments Tested in This Trial?

Interventions

• Home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching

Trial Overview The study tests a home-based mindfulness physical activity program monitored remotely, along with health coaching calls, aiming to reduce fatigue and improve life quality in older multiple myeloma patients. It explores whether these supportive interventions can help manage symptoms better than usual care.

How Is the Trial Designed?

Group I: Supportive Care (home-based physical activity) Experimental Treatment 7 Interventions

Patients participate in remote monitored home-based physical activity sessions including flexibility practice, slow walking and breathing exercises daily on 6 out of 7 days a week and receive telephone health coaching over 5-20 minutes once a week for 12 weeks. Patients also participate in a brief telephone interview at the end of 12 weeks. Additionally, patients wear a monitor on the wrist to monitor physical activity for 7 days during enrollment and at 3 months.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A systematic review of three trials involving 186 participants found that remotely delivered exercise interventions for sedentary adults with cancer did not significantly promote exercise behaviors or improve physical function.

None of the trials achieved a 75% adherence rate to exercise prescriptions that met current guidelines, indicating a need for better-designed remote exercise programs to effectively support cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote interventions to improve exercise behaviour in sedentary people living with and beyond cancer: a systematic review and meta-analysis. Ibeggazene, S., Turner, R., Rosario, D., et al.[2023]

Breast cancer patients often engage in low levels of physical activity during chemotherapy, which can negatively impact their health and recovery.

A Mobile Physical Activity Program was developed to encourage physical activity through a mobile app, offering features like disease tracking and health behavior recording, which could help improve patient engagement and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Physical Activity Intervention for Breast Cancer Patients During Chemotherapy. Geng, Z., Wu, F., Zhang, Y., et al.[2018]

A randomized trial involving 187 patients with newly diagnosed multiple myeloma found that a home-based individualized exercise program (HBIEP) did not significantly reduce fatigue, improve sleep, or enhance aerobic performance compared to usual care over a 15-week period.

Despite the minimal impact on fatigue and performance, the study suggests that exercise is safe for patients undergoing treatment for multiple myeloma and may provide physiological benefits, particularly in alleviating anemia when combined with epoetin alfa therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. Coleman, EA., Goodwin, JA., Kennedy, R., et al.[2021]

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 12-week physical activity intervention using wearable technology was safe and well-received by cancer survivors, with no reported adverse effects during the study.

Participants showed significant improvements in functional capacity and quality of life, although objectively measured physical activity levels did not change, indicating the need for further research to enhance efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a physiotherapy-led remotely delivered physical activity intervention in cancer survivors using wearable technology. The IMPETUS trial. Broderick, J., Haberlin, C., O Donnell, DM.[2022]

A study involving 87 breast and colorectal cancer survivors showed that using a Fitbit and receiving health coaching significantly increased their moderate-to-vigorous physical activity (MVPA) by nearly 50 minutes per week compared to those who only received printed materials.

This research is the first to demonstrate that combining wearable technology with remote health coaching can effectively enhance physical activity levels in cancer survivors living in remote areas, suggesting a promising approach for improving health outcomes in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). Hardcastle, SJ., Maxwell-Smith, C., Cavalheri, V., et al.[2023]

The study involves 288 adults aged 20 to 65 years, comparing the effectiveness of a remote physical activity promotion program with three different approaches over 6 months: minimal intervention with written advice, coaching sessions, and coaching with SMS prompts.

The primary goal is to assess self-reported physical activity levels, while secondary outcomes include objective activity measures, psychosocial factors, well-being, BMI, and adherence, which will help identify the most effective components for promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall). Fischer, X., Donath, L., Zwygart, K., et al.[2020]

The study demonstrated that a synchronous, online-delivered exercise maintenance program for cancer survivors is feasible, with high attendance rates (91.2% for classes and 97% for health coaching) and no reported adverse events, indicating safety.

Participants found the online format convenient, which may enhance accessibility for those in remote areas or immunocompromised individuals, while health coaching could further encourage healthier lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The online delivery of exercise oncology classes supported with health coaching: a parallel pilot randomized controlled trial. Eisele, M., Pohl, AJ., McDonough, MH., et al.[2023]

In a study of 192 women who completed treatment for breast cancer, engaging in at least 150 minutes of moderate-intensity physical activity per week was linked to improved physical functioning and quality of life after 3 months.

Sustaining this level of physical activity for at least 6 months led to significant reductions in fatigue and further improvements in physical functioning and quality of life, highlighting the importance of long-term exercise for psychosocial benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and psychosocial benefits among breast cancer patients. Pinto, BM., Dunsiger, S., Waldemore, M.[2022]

Health coaching delivered through videoconferencing (VC) resulted in significantly greater weight loss (8.23 kg) and increased physical activity (steps/day) compared to in-person coaching and a control group over a 12-week period, indicating its efficacy for adults with high BMI.

The VC group also showed a significant decrease in insulin resistance (HOMA-IR), suggesting that this method of health coaching can lead to improved metabolic health, while no significant changes were observed in glucose or HbA1c levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. Johnson, KE., Alencar, MK., Coakley, KE., et al.[2023]

This study evaluates the effectiveness of an internet-based physical activity promotion program for breast and prostate cancer survivors, comparing it to usual care, with 6 months of access to the program and assessments at baseline, 6, and 12 months.

The program includes personalized feedback and physiotherapy counseling, aiming to improve physical activity levels and overall well-being, with outcomes measured using accelerometers and self-reports, potentially offering a cost-effective solution for enhancing post-treatment recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(Cost-)effectiveness of an internet-based physical activity support program (with and without physiotherapy counselling) on physical activity levels of breast and prostate cancer survivors: design of the PABLO trial. van de Wiel, HJ., Stuiver, MM., May, AM., et al.[2019]

A home-based exercise intervention using activity trackers was feasible for 40 pediatric cancer patients, leading to a significant improvement in achieving individual daily step goals during treatment.

The intervention group reported better health-related quality of life compared to the control group, with 94% of participants finding the program meaningful and 80% feeling motivated, although improvements in motor performance were limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effects of a home-based intervention using activity trackers on achievement of individual goals, quality of life and motor performance in patients with paediatric cancer. Götte, M., Kesting, SV., Gerss, J., et al.[2023]

A 1-year randomized controlled trial involving cancer survivors showed that both a web-based program and a combination of health coaching with the web program significantly improved physical activity, weight management, and psychological distress compared to a control group.

The combination of health coaching and the web program led to a notable improvement in psychological well-being, as measured by the Post Traumatic Growth Inventory, indicating its effectiveness in reducing distress among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of health coaching and a web-based program on physical activity, weight, and distress management among cancer survivors: A multi-centered randomised controlled trial. Yun, YH., Lim, CI., Lee, ES., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06145581

Remote Monitoring With Health-Coaching to Improve ... This clinical trial tests the effectiveness of a home-based mindfulness physical activity program with remote monitoring combined with structured telephone- ...

2. trialx.com trialx.com/clinical-trials/listings/304655/remote-monitoring-with-health-coaching-to-improve-quality-of-life-in-older-patients-with-multiple-myeloma/

Remote Monitoring With Health-Coaching to Improve Quality of ... This clinical trial tests the effectiveness of a home-based mindfulness physical activity program with remote monitoring combined with structured telephone ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9554139/

Feasibility of a tailored and virtually supported home ... We hypothesized that the 12-week program would prove safe and feasible for people with MM and would demonstrate preliminary efficacy with key ...

4. withpower.com withpower.com/trial/phase-multiple-myeloma-2024-b538b

Remote Monitoring with Health-Coaching for Multiple Myeloma This clinical trial tests the effectiveness of a home-based mindfulness physical activity program with remote monitoring combined with structured telephone ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2152265025042272

The unmet psychological needs of people living with ... Mindfulness-based interventions are designed to help people manage stress, anxiety, depression, and other emotional difficulties by cultivating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8548591/

Lifestyle considerations in multiple myeloma - PMC To assess the feasibility of a 6-month home-based exercise program on MM patients and its effects on QOL and physiological outcomes.

7. clinical-lymphoma-myeloma-leukemia.com clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(25)04227-2/fulltext

The Unmet Psychological Needs of People Living With ... Myeloma exercise interventions often lack a psychological component, missing an opportunity to address psychological challenges in combination ...