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

Study Overview
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Behavioral: Health Through Activity


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Through Activity (HTA) Intervention<br>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<br>* Six, weekly, customized sessions with licensed physical and occupational therapists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Completion Rate | 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. | Up to 3 months | 
| Participant Satisfaction | 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. | Up to 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Physical Therapy, Exercise Program