25 Participants Needed

Remote Monitoring with Health-Coaching for Multiple Myeloma

CT
Overseen ByClinical Trials Referral Office
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Proteasome inhibitors, Immunomodulatory agents, Anti-C38 antibodies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.58111213

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 - Mayo Clinic

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.
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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
1Treatment groups
Experimental Treatment
Group I: Supportive Care (home-based physical activity)Experimental Treatment7 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.

Find a Clinic Near You

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.
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.
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.
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]

References

Effects of exercise on fatigue, sleep, and performance: a randomized trial. [2021]
Feasibility of a tailored and virtually supported home exercise program for people with multiple myeloma using a novel eHealth application. [2022]
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]
Physical activity and psychosocial benefits among breast cancer patients. [2022]
Mobile Physical Activity Intervention for Breast Cancer Patients During Chemotherapy. [2018]
Telemedicine-Based Health Coaching Is Effective for Inducing Weight Loss and Improving Metabolic Markers. [2023]
The online delivery of exercise oncology classes supported with health coaching: a parallel pilot randomized controlled trial. [2023]
A randomized controlled trial of Promoting Physical Activity in Regional and Remote Cancer Survivors (PPARCS). [2023]
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]
Coaching and Prompting for Remote Physical Activity Promotion: Study Protocol of a Three-Arm Randomized Controlled Trial (Movingcall). [2020]
(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]
Feasibility and preliminary efficacy of a physiotherapy-led remotely delivered physical activity intervention in cancer survivors using wearable technology. The IMPETUS trial. [2022]
Remote interventions to improve exercise behaviour in sedentary people living with and beyond cancer: a systematic review and meta-analysis. [2023]
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