Идёт набор NCT06145581

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

Без фазы С лечением Multiple Myeloma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Supportive Care (home-based physical activity), Exercise Intervention, telephone interview, Remote Monitoring.
Кому может быть актуально: Состояния в реестре: Multiple Myeloma. Базовые параметры: от 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое Supportive Care (home-based physical activity)
Receive health coaching
Другое Exercise Intervention
Participate in home-based physical activity
Другое telephone interview
Participate in a telephone interview
Другое Remote Monitoring
Undergo remote monitoring
Процедура Patient Monitoring
Monitor physical activity
Другое Questionnaire Administration
Ancillary studies
Другое Electronic Health Record Review
Ancillary studies

Первичные конечные точки

Changes in fatigue - BFI [Срок оценки: Baseline; 3 months]
Changes in fatigue - FACIT-F [Срок оценки: Baseline; 3 months]

Вторичные конечные точки (2)

Changes in quality of life - PROMIS-10 [Срок оценки: Baseline; 3 months]
Effectiveness - qualitative interview [Срок оценки: 3 months]

Критерии участия

Критерии включения

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