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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06145581
Other study ID # 23-005783
Secondary ID NCI-2023-0711023
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date June 30, 2025

Study information

Verified date March 2024
Source Mayo Clinic
Contact Clinical Trials Referral Office
Phone 855-776-0015
Email mayocliniccancerstudies@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 30, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Supportive Care (home-based physical activity)
Receive health coaching
Other:
Exercise Intervention
Participate in home-based physical activity
telephone interview
Participate in a telephone interview
Remote Monitoring
Undergo remote monitoring
Procedure:
Patient Monitoring
Monitor physical activity
Other:
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in fatigue - BFI 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). Baseline; 3 months
Primary Changes in fatigue - MFIS 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). Baseline; 3 months
Primary Changes in fatigue - MFSI-SF 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). Baseline; 3 months
Primary Changes in fatigue - FACIT-F 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). Baseline; 3 months
Primary Changes in fatigue - CFS 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). Baseline; 3 months
Secondary Changes in quality of life - EORTC QLQ-C30 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). Baseline; 3 months
Secondary Changes in quality of life - EORTC QLQ-MY20 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). Baseline; 3 months
Secondary Changes in quality of life - EORTC QLQ-ELD14 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). Baseline; 3 months
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