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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2027-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supportive Care (home-based physical activity)

Intervention Type BEHAVIORAL

Receive health coaching

Exercise Intervention

Intervention Type OTHER

Participate in home-based physical activity

telephone interview

Intervention Type OTHER

Participate in a telephone interview

Remote Monitoring

Intervention Type OTHER

Undergo remote monitoring

Patient Monitoring

Intervention Type PROCEDURE

Monitor physical activity

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Interventions

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Supportive Care (home-based physical activity)

Receive health coaching

Intervention Type BEHAVIORAL

Exercise Intervention

Participate in home-based physical activity

Intervention Type OTHER

telephone interview

Participate in a telephone interview

Intervention Type OTHER

Remote Monitoring

Undergo remote monitoring

Intervention Type OTHER

Patient Monitoring

Monitor physical activity

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No