Back to resultsHealth Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Through Activity
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Myeloma focused on measuring Multiple Myeloma, Physical Therapy, Exercise Program
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.
Sites / Locations
- Massachusetts General Hospital Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Health Through Activity (HTA) Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Rate of Participant Enrollment
Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility.
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.
Screening Rate
Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility
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%.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05700747
First Posted
January 17, 2023
Last Updated
October 17, 2023
Sponsor
MGH Institute of Health Professions
1. Study Identification
Unique Protocol Identification Number
NCT05700747
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MGH Institute of Health Professions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Physical Therapy, Exercise Program
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health Through Activity (HTA) Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Through Activity
Intervention Description
Six, weekly, customized sessions with licensed physical and occupational therapists.
Primary Outcome Measure Information:
Title
Rate of Participant Enrollment
Description
Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility.
Time Frame
At screening
Title
Assessment Completion Rate
Description
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.
Time Frame
Up to 4 months
Title
Screening Rate
Description
Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility
Time Frame
Up to 4 months
Title
Eligibility Rate
Description
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%.
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Intervention Completion Rate
Description
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.
Time Frame
Up to 3 months
Title
Participant Satisfaction
Description
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.
Time Frame
Up to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Lyons, ScD, OTR/L
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
Learn more about this trial
Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
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