Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Physical Therapy, Exercise Program
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.
Interventions
BEHAVIORALHealth Through Activity
Six, weekly, customized sessions with licensed physical and occupational therapists.
Sponsors
MGH Institute of Health Professions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participant Enrollment | At screening | Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility. |
| Assessment Completion Rate | 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 | Up to 4 months | Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility |
| Eligibility Rate | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Completion Rate | Up to 3 months | 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 | Up to 4 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Health Through Activity (HTA) Intervention |
|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 4.7 |
| Race/Ethnicity, Customized Ethnicity: Non-Hispanic/Latino | 5 Participants |
| Race/Ethnicity, Customized Race: White | 5 Participants |
| Sex/Gender, Customized Females | 2 Participants |
| Sex/Gender, Customized Males | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: Up to 4 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Through Activity (HTA) Intervention | Assessment Completion Rate | 5 Participants |
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%.
Time frame: Up to 4 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Through Activity (HTA) Intervention | Eligibility Rate | 5 Participants |
Primary
Rate of Participant Enrollment
Number participants enrolled / Number screened positive & eligible. A rate of at least 75% will indicate feasibility.
Time frame: At screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Through Activity (HTA) Intervention | Rate of Participant Enrollment | 5 Participants |
Primary
Screening Rate
Number patients screened/ Number patients identified as potentially eligible. Screening rate of at least 75% will indicate feasibility
Time frame: Up to 4 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Through Activity (HTA) Intervention | Screening Rate | 11 Participants |
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.
Time frame: Up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Through Activity (HTA) Intervention | Intervention Completion Rate | 5 Participants |
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.
Time frame: Up to 4 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Participants felt well supported by the interventionists | 5 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Participants described feeling connected to the interventionists. | 3 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Optimism and openness of interventionists kept participants engaged | 3 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Participants felt the program structure was both effective and adaptable to their needs | 5 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Participants identified areas of growth | 5 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | The program catalyzed participants to stay engaged, take action, and reflect on progress | 5 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Suggestion to tailor messaging/advertising for better clarity of target audience. | 1 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Suggestion to highlight that the program can be adapted to various performance levels | 2 Participants |
| Health Through Activity (HTA) Intervention | Participant Satisfaction | Suggestion to explain why program addresses a wide range of health aspects vs going deep on one | 3 Participants |