Remote Monitoring With Health-Coaching to Improve Quality of Life in Older Patients With Multiple Myeloma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Supportive Care (home-based physical activity) 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. |
Behavioral: Supportive Care (home-based physical activity)
Receive health coaching
Other: Exercise Intervention
Participate in home-based physical activity
Other: telephone interview
Participate in a telephone interview
Other: Remote Monitoring
Undergo remote monitoring
Procedure: Patient Monitoring
Monitor physical activity
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Changes in fatigue - BFI [Baseline; 3 months]
Changes in fatigue will be assessed the Brief Fatigue Inventory (BFI), a 4-item questionnaire asking the participant about their experiences in the past 24 hours. Respondents rate each item from 0 (no fatigue) to 10 (fatigue as bad as you can imagine).
- Changes in fatigue - MFIS [Baseline; 3 months]
Changes in fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS), a 21-item questionnaire asking participants about fatigue during the past 4 weeks. Each item is rated on a five-point scale from 0 (never) to 4 (almost always).
- Changes in fatigue - MFSI-SF [Baseline; 3 months]
Changes in fatigue will be assessed using the Multidimensional Fatigue Syndrome Inventory (MFSI-SF). The MFSI-SF consists of 30 statements designed to assess the multidimensional nature of fatigue. Respondents indicate the extent to which they have experienced each symptom during the preceding one-week period. Each item is rated on a five-point scale from 0 (not at all) to 4 (extremely).
- Changes in fatigue - FACIT-F [Baseline; 3 months]
Changes in fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). The FACIT-F questionnaire consists of 40 statements designed to assess self-reported fatigue and its impact upon daily activities and function over the past 7 days. Each statement rated on a five-point scale from 0 (not at all) to 4 (very much).
- Changes in fatigue - CFS [Baseline; 3 months]
Changes in fatigue will be assessed using the Cancer Fatigue Scale- (CFS), a 15-item questionnaire to assess the participant's current state of fatigue. Each question is answered with a five-point scale from 1 (no) to 5 (very much).
Secondary Outcome Measures
- Changes in quality of life - EORTC QLQ-C30 [Baseline; 3 months]
Changes in quality of life will be assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-30 (EORTC QLQ-C30), a 30-item questionnaire designed to measure cancer patients' physical, psychological and social function. The first 28 questions are answered on a 4-point scale from 1 (not al all) to 5 (very much). The final two questions are answered by choosing a number in range from 1 (very poor) to 7 (excellent).
- Changes in quality of life - EORTC QLQ-MY20 [Baseline; 3 months]
Changes in quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20), a 20-item questionnaire designed to measure the quality of life of people with multiple myeloma during the pas week. Each question is answered on a 4-point scale from 1 (not al all) to 5 (very much).
- Changes in quality of life - EORTC QLQ-ELD14 [Baseline; 3 months]
Changes in quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Elderly Cancer Patients Module (EORTC QLQ-ELD14), a 14-item questionnaire designed to measure important age-specific issues for older patients with cancer. Each question is answered on a 4-point scale from 1 (not al all) to 5 (very much).
Eligibility Criteria
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
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Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2
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The ability to read and respond to questions in English
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Follows up at Mayo Clinic or outside Mayo Clinic
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Age ≥ 65 years
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Shaji K. Kumar, M.D., Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-005783
- NCI-2023-07110
- 23-005783