Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Myeloma
- Sponsor
- MGH Institute of Health Professions
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Rate of Participant Enrollment
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Kathleen Lyons, ScD, OTR/L
Principal Investigator
MGH Institute of Health Professions
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.
Outcomes
Primary Outcomes
Rate of Participant Enrollment
Time Frame: At screening
Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.
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.
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%.
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
Secondary Outcomes
- Intervention Completion Rate(Up to 3 months)
- Participant Satisfaction(Up to 4 months)