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

Remote Monitoring With Health-Coaching for Lifestyle Changes 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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Electronic Health Record Review; Behavioral: Supportive Care (home-based physical activity); Other: Exercise Intervention; Other: telephone interview; Other: Remote Monitoring; Procedure: Patient Monitoring

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Nadine H. Abdallah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: Questionnaire Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fatigue - BFI	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).	Baseline; 3 months
Changes in fatigue - FACIT-F	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).	Baseline; 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life - PROMIS-10	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.	Baseline; 3 months
Effectiveness - qualitative interview	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.	3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Nadine H. Abdallah, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Patient Care; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Patient Care Management; Interviews as Topic; Palliative Care; Remote Patient Monitoring
• Other Study ID Numbers: 23-005783 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2023-07110 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No