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Trial Title:
Remote Monitoring with Health-Coaching to Improve Quality of Life in Older Patients with Multiple Myeloma
NCT ID:
NCT06145581
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Supportive Care (home-based physical activity)
Description:
Receive health coaching
Arm group label:
Supportive Care (home-based physical activity)
Intervention type:
Other
Intervention name:
Exercise Intervention
Description:
Participate in home-based physical activity
Arm group label:
Supportive Care (home-based physical activity)
Intervention type:
Other
Intervention name:
telephone interview
Description:
Participate in a telephone interview
Arm group label:
Supportive Care (home-based physical activity)
Intervention type:
Other
Intervention name:
Remote Monitoring
Description:
Undergo remote monitoring
Arm group label:
Supportive Care (home-based physical activity)
Intervention type:
Procedure
Intervention name:
Patient Monitoring
Description:
Monitor physical activity
Arm group label:
Supportive Care (home-based physical activity)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (home-based physical activity)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Supportive Care (home-based physical activity)
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.
Detailed 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) and Functional Assessment of Chronic Illness
Therapy-Fatigue (FACIT-F) questionnaires and 2) Health-related quality of life assessed
by the Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS
Global-10) questionnaire, 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with MM and has received treatment with >= 1 prior lines of treatment, and
currently on maintenance treatment with a proteasome inhibitor and/or
immunomodulatory agent, and/or anti-C38 antibody
- The ability to read and respond to questions in English
- 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
- Have wi-fi connection, as the program requires wi-fi to operate
Exclusion Criteria:
- Does not meet listed inclusion criteria
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Shaji K. Kumar, MD
Start date:
July 12, 2024
Completion date:
August 30, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06145581
https://www.mayo.edu/research/clinical-trials
