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

Multiple Myeloma Clinical Trial

Official title:

Remote Monitoring With Health-Coaching for Lifestyle Changes in Older Patients With Multiple Myeloma

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
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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