Multiple MyelomaNCT05700747
Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
A study testing Health Through Activity in people with Multiple Myeloma, run by MGH Institute of Health Professions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Health Through Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥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?"
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
About this study
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)
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Health Through Activity
- Keywords
- Multiple Myeloma, Physical Therapy, Exercise Program
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Through ActivityBehavioural
Six, weekly, customized sessions with licensed physical and occupational therapists.
| Study group | Role | What they receive |
|---|---|---|
| Health Through Activity (HTA) Intervention | Experimental | 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. Receives: Behavioral: Health Through Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Participant Enrollment
Number participants enrolled / Number screened positive \& eligible. A rate of at least 75% will indicate feasibility.
Measured: 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.
Measured: Up to 4 months
Screening Rate
Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility
Measured: 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%.
Measured: Up to 4 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MGH Institute of Health Professions
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Lyons, ScD, OTR/L, MGH Institute of Health Professions
- Investigators
- Kathleen Lyons, ScD, OTR/L, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700747
- Sponsor's protocol ID
- 22-437
- Status last verified
- Nov 2025
- First submitted
- 17 Jan 2023
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05700747
- Acronym / sponsor ID
- 22-437
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Physical Therapy, Exercise Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MGH Institute of Health ProfessionsUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Through Activity (HTA) Intervention | Experimental | Behavioral: Health Through ActivityParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -≥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?"
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Through ActivitySix, weekly, customized sessions with licensed physical and occupational therapists. | Behavioural | Health Through Activity (HTA) Intervention |
Primary outcome
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.
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
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%.
2 secondary outcomes
Intervention Completion Rate
Time frame: Up to 3 months
Participant Satisfaction
Time frame: Up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Lyons, ScD, OTR/L principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Through Activity in people with Multiple Myeloma, run by MGH Institute of Health Professions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participant Enrollment (time frame: At screening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.