Skip to main content
OpenTrials
Completed

NCT Number: NCT05700747

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215, United States

About this study

The goal of this single arm, pilot study of the Health Through Activity (HTA) rehabilitation intervention for people living with multiple myeloma is to determine if investigators can feasibly deliver the program out of the IMPACT Practice Center at the MGH Institute for Health Professions.

  • The six-session 'Health Through Activity' program provides a customized exercise plan and encourages engagement in activities to reduce disability and improve quality of life.
  • Study procedures including screening for eligibility, in-clinic visits, questionnaires, and surveys.
  • Participation in this research study is expected to last up to 4 months.

It is expected that up to 20 people will take part in this research study.

An internal grant from the Massachusetts General Hospital Institute of Health Professions is providing equipment and staffing for this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

-≥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?"

Exclusion criteria

  • 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.

Treatment and study plan

Health Through Activity

Behavioral

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

Primary outcomes

  1. Rate of Participant Enrollment

    Time frame: At screening

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

  2. Assessment Completion Rate

    Time frame: Up to 4 months

    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.

  3. Screening Rate

    Time frame: Up to 4 months

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

  4. Eligibility Rate

    Time frame: Up to 4 months

    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%.

Secondary outcomes

  1. Intervention Completion Rate

    Time frame: Up to 3 months

    Defined as at least 75% of participants complete all six sessions of Health Through Activity (HTA) and if the mean number of sessions is greater than or equal to 4.

  2. Participant Satisfaction

    Time frame: Up to 4 months

    Assessed by the Satisfaction survey which is a 7-item survey that is rated on a 5-point Likert scale. Any item on the Satisfaction survey that generates a mean score of < 4 will trigger consideration of modification to the HTA program.

Sponsors and collaborators

Lead sponsor

MGH Institute of Health Professions

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2023
Registry last updated
Dec 16, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.