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

NCT ID: NCT05700747

Last Updated: 2025-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-03-28

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Health Through Activity (HTA) Intervention

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.

Group Type EXPERIMENTAL

Health Through Activity

Intervention Type BEHAVIORAL

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

Interventions

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Health Through Activity

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MGH Institute of Health Professions

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Lyons, ScD, OTR/L

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathleen Lyons, ScD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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22-437

Identifier Type: -

Identifier Source: org_study_id