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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05700747
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	MGH Institute of Health Professions
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kathleen Lyons, ScD, OTR/L
Principal Investigator Affiliation	Massachusetts General Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Interventions

Behavioral: - Health Through Activity

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215

Site Contact

Kathleen Lyons, ScD, OTR/L

klyons16@mgb.org

617-643-5372

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