Multiple Myeloma Clinical Trial

Remote Monitoring With Health-Coaching to Improve Quality of Life in Older Patients With Multiple Myeloma

Summary

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.

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Full Description

PRIMARY OBJECTIVE:

I. To assess the effect-size of a novel combined home-based mindfulness physical activity program with telephonic health coaching on 1) patient-reported fatigue assessed by the Brief Fatigue Inventory (BFI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Multidimensional Fatigue Syndrome Inventory Short Form (MFSI-SF), Modified Fatigue Impact Scale (MFIS), and Cancer Fatigue Score (CFS) questionnaires and 2) Health-related quality of life assessed by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), EORTC QLQ - Multiple Myeloma Module 20 (MY20), and EORTC QLQ elderly cancer patients (ELD)14 questionnaires, and 3) physical activity levels measured by steps per day.

OUTLINE:

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.

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Eligibility Criteria

Inclusion Criteria:

Diagnosed with multiple myeloma (MM) and has received treatment with >= 1 prior lines of treatment, and currently on observation or maintenance treatment with a proteasome inhibitor and/or immunomodulatory agent, and/or anti-C38 antibody
Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2
The ability to read and respond to questions in English
Follows up at Mayo Clinic or outside Mayo Clinic
Age ≥ 65 years
Moderate or higher fatigue ( > 4) on a scale of 0-10 based on fatigue rating to question: Rate your average fatigue over the last week, where 0 is no fatigue and 10 is extreme fatigue

Exclusion Criteria:

Patient has a cognitive or psychiatric condition as determined by the treating hematologist to prohibit study consent or participation

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

20

Study ID:

NCT06145581

Recruitment Status:

Not yet recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
[email protected]
Shaji K. Kumar, M.D.
Principal Investigator

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

20

Study ID:

NCT06145581

Recruitment Status:

Not yet recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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