Remote Monitoring With Health-Coaching to Improve Quality of Life in Older Patients With Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supportive Care (home-based physical activity), Exercise Intervention, telephone interview, Remote Monitoring.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remote Monitoring With Health-Coaching for Lifestyle Changes in Older Patients With Multiple Myeloma
Overview
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.
Interventions
- 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 - Other Electronic Health Record Review
Ancillary studies
Primary outcome measures
- Changes in fatigue - BFI [Time frame: Baseline; 3 months]
- Changes in fatigue - FACIT-F [Time frame: Baseline; 3 months]
Secondary outcome measures (2)
- Changes in quality of life - PROMIS-10 [Time frame: Baseline; 3 months]
- Effectiveness - qualitative interview [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06145581 · 23-005783 · NCI-2023-07110 · 23-005783