Recruiting

Health-Coaching

Sponsor:

Mayo Clinic

Code:

NCT06145581

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Supportive Care (home-based physical activity)

Exercise Intervention

telephone interview

Remote Monitoring

Patient Monitoring

Study Details

Brief 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.

Conditions

Multiple Myeloma

Study ID

NCT06145581

Start date

Jul 12, 2024

Status verified date

Apr, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Supportive Care (home-based physical activity)

Receive health coaching

Exercise Intervention

Participate in home-based physical activity

telephone interview

Participate in a telephone interview

Remote Monitoring

Undergo remote monitoring

Patient Monitoring

Monitor physical activity

Questionnaire Administration

Ancillary studies

Electronic Health Record Review

Ancillary studies

Primary outcome measure

  • Changes in fatigue - BFI [ Time Frame: Baseline; 3 months ]
  • Changes in fatigue - FACIT-F [ Time Frame: Baseline; 3 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Nadine H. Abdallah, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-13.