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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)
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health Through Activity (HTA) Intervention | Experimental | Participants will undergo study procedures as outlined:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Through Activity | Behavioral | Six, weekly, customized sessions with licensed physical and occupational therapists. |
|
| 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 |
| 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 |
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Inclusion Criteria:
-≥18 years of age
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Lyons, ScD, OTR/L | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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16 patients were approached 11/16 were formally screened 6/11 were not interested/eligible 5/11 were interested and eligible 5/5 interested/eligible patients enrolled
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Through Activity (HTA) Intervention | Participants will undergo study procedures as outlined:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Through Activity (HTA) Intervention | Participants will undergo study procedures as outlined:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Participant Enrollment | Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility. | Posted | Count of Participants | Participants | At screening |
|
From enrollment until end of follow-up (up to 4 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Health Through Activity (HTA) Intervention | Participants will undergo study procedures as outlined:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathleen Lyons | MGH Institute of Health Professions | 617-643-5372 | klyons2@mghihp.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2025 | Sep 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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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 |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 4 months |
|
|
|
| Primary | Screening Rate | Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility | Our outcome of Screening Rate depends on a denominator of "Number patients identified as potentially eligible." Therefore, this number is larger than the 5 participants who enrolled/started the study. | Posted | Count of Participants | Participants | Up to 4 months |
|
|
|
| Primary | 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%. | Our outcome of Eligibility Rate depends on a denominator of "Number screened." Therefore, this number is larger than the 5 participants who enrolled/started the study. | Posted | Count of Participants | Participants | Up to 4 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 3 months |
|
|
|
| Secondary | 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. | 5/5 participants engaged in one-on-one semi-structured qualitative interviews following completion of intervention which allowed us to gauge overall participant experiences/satisfaction within the study and intervention. Unfortunately, a protocol deviation (reported to the IRB) resulted in the 7-item satisfaction survey not being included in the data collection materials. This measure will not be collected as participants had already completed the program and study will be closed to enrollment. | Posted | Count of Participants | Participants | Up to 4 months |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| Participants felt the program structure was both effective and adaptable to their needs |
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| Participants identified areas of growth |
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| The program catalyzed participants to stay engaged, take action, and reflect on progress |
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| Suggestion to tailor messaging/advertising for better clarity of target audience. |
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| Suggestion to highlight that the program can be adapted to various performance levels |
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| Suggestion to explain why program addresses a wide range of health aspects vs going deep on one |
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