Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma

NCT05700747 | Completed Results

• 1 other identifier: 22-437
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore whether a structured program can help reduce the challenges of decreased physical functioning and quality of life for participants with multiple myeloma by providing a customized exercise program and fostering engagement in meaningful activities. The name of the study intervention involved in this study is: Health Through Activity (HTA) (six-session, rehabilitation exercise regimen)

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Physical Therapy; Exercise Program

Outcome Measures

Primary Outcomes (4)

• Rate of Participant Enrollment

  Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.

  At screening

• Assessment Completion Rate

  Defined as the number of participants completing each of the three study assessments to number of participants enrolled. A completion rate of 85% will indicate feasibility.

  Up to 4 months

• Screening Rate

  Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility

  Up to 4 months

• Eligibility Rate

  Number patients screening positive \& eligible / Number screened. Eligibility rate is influenced by how many people in the clinical population are experiencing disability. Based on our pilot study, expected rate to be at least 35%.

  Up to 4 months

Secondary Outcomes (2)

• Intervention Completion Rate

  Up to 3 months

• Participant Satisfaction

  Up to 4 months

Study Arms (1)

Health Through Activity (HTA) Intervention

EXPERIMENTAL

Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.

Behavioral: Health Through Activity

Interventions

Health Through Activity BEHAVIORAL

Six, weekly, customized sessions with licensed physical and occupational therapists.

Health Through Activity (HTA) Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Diagnosed with multiple myeloma currently receiving maintenance therapy,
• Experiencing disability as indicated by an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"

You may not qualify if:

• Bone pain that is either a) new onset or increased in the past month or b) uncontrolled i.e., in the patient's estimation the bone pain "greatly interferes with daily activities"
• History of fracture in the past 12 months without fixation, or
• Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire\[29\] (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
• We will also exclude individuals with moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six item cognitive screening tool.

Sponsors & Collaborators

• MGH Institute of Health Professions: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Kathleen Lyons
• Organization: MGH Institute of Health Professions

klyons2@mghihp.edu

617-643-5372

Study Officials

• Kathleen Lyons, ScD, OTR/L

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: February 1, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)