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NCT Number: NCT06145581

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

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Nadine H. Abdallah, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive Care (home-based physical activity)

Behavioral

Receive health coaching

Exercise intervention

Other

Participate in home-based physical activity

telephone interview

Other

Participate in a telephone interview

Remote monitoring

Other

Undergo remote monitoring

Patient Monitoring

Procedure

Monitor physical activity

Questionnaire Administration

Other

Ancillary studies

Electronic Health Record Review

Other

Ancillary studies

Primary outcomes

  1. Changes in fatigue - BFI

    Time frame: Baseline; 3 months

    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).

  2. Changes in fatigue - FACIT-F

    Time frame: Baseline; 3 months

    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).

Secondary outcomes

  1. Changes in quality of life - PROMIS-10

    Time frame: Baseline; 3 months

    The Patient Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire is a 10-item questionnaire that assess quality of life. All questions have a five-point Likert-type scale, except for the rating of pain which has a ten-point scale.

  2. Effectiveness - qualitative interview

    Time frame: 3 months

    At the end of the 12-week intervention, a member of the study team trained in qualitative interviewing will contact the participant and conduct an interview exploring items such as what the participant found helpful, what improvements they would like, and would they recommend this program to others. The call will be recorded so that it can be transcribed later looking for themes. At the end of the study the recordings will be destroyed.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 24, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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