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

Trial Summary

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 data supports the effectiveness of the treatment for Remote Monitoring with Health-Coaching for Multiple Myeloma?

Research shows that home-based exercise programs and eHealth interventions can be beneficial for multiple myeloma patients, as they offer flexibility and supervision, which are important for managing the side effects of the disease. Additionally, health coaching and web-based programs have been effective in improving physical activity and managing distress among cancer survivors, suggesting potential benefits for multiple myeloma patients as well. ^{1 2 3 4 5}

Is the remote monitoring with health-coaching program safe for humans?

The studies reviewed suggest that remote health coaching and physical activity programs, including those using wearable technology and telehealth, have been safely implemented in various populations, such as cancer survivors and individuals with high body mass index, without significant safety concerns reported. ^{6 7 8 9 10}

How is the remote monitoring with health-coaching treatment for multiple myeloma different from other treatments?

This treatment is unique because it combines a home-based mindfulness physical activity program with remote monitoring and structured telephone-based health coaching, which is not commonly used in standard multiple myeloma treatments. It leverages technology to provide personalized support and guidance, potentially improving physical activity and overall well-being for patients in a convenient, home-based setting. ^{5 8 11 12 13}

What is the purpose of this trial?

This clinical trial tests the effectiveness of a home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching to decrease fatigue and improve quality of life in older patients with multiple myeloma (MM). Studies have shown that MM patients have the highest symptom burden among all blood cancers, with older patients experiencing more symptoms and problems, such as fatigue and decreased quality of life, compared to younger patients. There is some data to support that physical activity may have beneficial effects on fatigue, physical function, and quality of life in older cancer patients. Studies have also shown that older patients prefer activities that are gentle, holistic, and home-based. Mindfulness-based interventions have been shown to have positive effects on sleep, depression, anxiety and cancer-related fatigue. Health coaching is a patient centered behavioral change intervention that is delivered by various healthcare professionals and involves goal-setting, self-discovery, and accountability. Health coaching interventions have been shown to increase physical activity levels and improve quality of life. A home-based mindfulness physical activity program with remote monitoring combined with structured telephone-based health coaching may decrease fatigue and improve the quality of life in older patients with MM.

Research Team

Shaji K. Kumar, M.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. [2021]

2. United States 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. [2022]

3. England 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. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Physical activity and psychosocial benefits among breast cancer patients. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Physical Activity Intervention for Breast Cancer Patients During Chemotherapy. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The online delivery of exercise oncology classes supported with health coaching: a parallel pilot randomized controlled trial. [2023]

8. China pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). [2023]

9. England 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. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall). [2020]

11. England 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. [2019]

12. England 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. [2022]

13. England 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. [2023]