Clinical trial NCT05700747: Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
Official title: Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Physical Therapy
Exercise Program
Lead sponsor: MGH Institute of Health Professions
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Participant Enrollment
timeFrame: At screening
measure: Assessment Completion Rate
timeFrame: Up to 4 months
measure: Screening Rate
timeFrame: Up to 4 months
measure: Eligibility Rate
timeFrame: Up to 4 months
Secondary outcomes:
measure: Intervention Completion Rate
timeFrame: Up to 3 months
measure: Participant Satisfaction
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Kathleen Lyons, ScD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: