Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma
Phase: NA
Conditions: Multiple Myeloma
Sponsor: MGH Institute of Health Professions

PROTOCOL TITLE: Health Through Activity: A pilot study of a rehabilitation intervention 
for people living with multiple myeloma 
 
 
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DF/HCC NON-CLINICAL PROTOCOL TEMPLATE 
Version Date: January 31, 2020 
 
 
PROTOCOL TITLE: 
 
Health Through Activity:  
A pilot study of a rehabilitation intervention for people living with multiple myeloma 
 
PRINCIPAL INVESTIGATOR: 
 
Kathleen Lyons, ScD, OTR/L 
Department of Occupational Therapy, MGH Institute of Health Professions 
Associate Member, Cancer Care Delivery Research Program, Dana Farber/Harvard 
Cancer Center, Boston, MA 
Klyons2@mghihp.edu 
 
 
 
VERSION NUMBER: 
 
1.4 
 
DATE: 
 
02.06.2025 

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Table of Contents 
1.0 
Objectives* .............................................................................................................. 3 
2.0 
Background* ............................................................................................................ 3 
3.0 
Inclusion and Exclusion Criteria* ............................................................................ 6 
4.0 
Study-Wide Number of Subjects* ........................................................................... 7 
5.0 
Study-Wide Recruitment Methods* ........................................................................ 7 
6.0 
Study Timelines* ..................................................................................................... 9 
7.0 
Study Endpoints* ..................................................................................................... 9 
8.0 
Procedures Involved*............................................................................................... 9 
9.0 
Data Banking* ....................................................................................................... 14 
10.0 Data Management* and Confidentiality ................................................................ 15 
11.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 17 
12.0 Withdrawal of Subjects* ........................................................................................ 19 
13.0 Risks to Subjects* .................................................................................................. 20 
14.0 Potential Benefits to Subjects* .............................................................................. 22 
15.0 Community-Based Participatory Research* .......................................................... 22 
16.0 Sharing of Results with Subjects* ......................................................................... 22 
17.0 Setting .................................................................................................................... 22 
18.0 Resources Available............................................................................................... 23 
19.0 Prior Approvals ...................................................................................................... 24 
20.0 Recruitment Methods ............................................................................................. 24 
21.0 Local Number of Subjects ..................................................................................... 25 
22.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 25 
23.0 Compensation for Research-Related Injury ........................................................... 26 
24.0 Economic Burden to Subjects ................................................................................ 26 
25.0 Consent Process ..................................................................................................... 26 
26.0 Process to Document Consent in Writing .............................................................. 27 
27.0 Drugs or Devices.................................................................................................... 27 
 

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1.0 
Objectives 
 
This is a single arm feasibility study of a rehabilitation intervention designed to reduce 
disability in people living with multiple myeloma. 
 
Aim 1: To evaluate the feasibility of enrolling and retaining participants with 
multiple myeloma into a pilot test of the refined HTA intervention, delivered from 
MGH Institute of Health Professions (i.e., within the IMPACT Practice Center or 
clinical research laboratories) and via telehealth technology. 
 
Aim 2: To evaluate the feasibility of administering the outcome assessment battery 
that includes patient-reported outcomes of disability, activity level, quality of life, 
fatigue, and exercise self-efficacy, and performance-based outcomes of balance, gait 
speed, and strength. 
 
Aim 3: To assess the acceptability of the refined HTA intervention and assessment 
battery and utilize stakeholder feedback to identify further modifications to enhance 
acceptability. 
 
 
2.0 
Background 
 
People living with multiple myeloma are at risk of developing disability 
 
Multiple myeloma (MM) is a chronic malignancy of the plasma cells in bone marrow and 
is the second most common hematological cancer.[1] Most commonly diagnosed in 
people over the age of 65,[2] MM has a five-year relative survival rate of 58%.[3] 
Though considered incurable, more individuals are living with MM as a chronic health 
condition for years due to advancements in therapeutic approaches to managing MM.[4] 
 
Many people living with MM experience distressing symptoms which limit their ability 
to engage in meaningful activities. While the impact of MM is variable, the most 
prevalent symptoms experienced are fatigue, pain, insomnia, and peripheral 
neuropathy.[1, 5-8] Additionally, up to 80% of individuals with MM develop osteolytic 
skeletal lesions which can cause bone pain and pathologic fractures.[1, 9] These sequelae 
of MM and its treatments, along with commonly reported symptoms of anxiety and 
depression,[10] may result in decreased physical functioning, limited health-related 
quality of life, and difficulty engaging in activities related to valued roles.[1, 5, 6] 
Furthermore, people living with MM are at an increased risk of falling,[11] and many 
fear pain or injury (e.g., pathological fractures) which can lead to avoidance of physical 
activity and exercise. Taken together, people with MM are at high risk for developing 
disability, i.e., a perceived limitation in and reduced frequency of activity 
engagement.[12-14] 
 
Rehabilitation interventions to reduce disability 

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The primary goals of cancer rehabilitation are to reduce or prevent disability and 
maximize quality of life of people living with cancer. In his early description of cancer 
rehabilitation, Dietz suggested rehabilitation strategies could be categorized in terms of 
whether they were restorative, supportive, preventive, or palliative in intent.[15] The first 
two categories are most relevant to this proposal. When attempting to reduce disability, 
restorative strategies are utilized to reduce symptoms and restore physical and 
psychosocial capabilities to whatever degree possible. Exercise, balance training, and 
engagement in pleasurable activities are examples of restorative strategies that can 
improve strength, mobility, and reduce depressive symptoms. Supportive strategies 
involve adapting activities or modifying the physical or social environment in order to 
perform an activity, despite any residual symptoms or impairments. Examples of 
supportive strategies involve utilizing adaptive equipment, eliminating steps of an 
activity, or rearranging the environment to allow a person to sit while performing an 
activity.   
  
To date, there has not been a definitive test evaluating the degree to which a 
comprehensive rehabilitative approach utilizing restorative and supportive strategies can 
reduce disability in people living with MM. Exercise is the most studied restorative 
strategy for this population.[16, 17] The Canadian Physiotherapy Association published 
clinical guidelines for the promotion of exercise for people living with MM, citing the 
feasibility and safety of exercise among individuals with MM as well as the positive 
impacts on functional mobility, self-care, physical performance (i.e., aerobic capacity and 
muscular strength), and physical activity.[18] Our team has pilot tested a supportive 
strategy that teaches older adults with cancer how to increase engagement in valued 
activities by utilizing activity adaptation, environmental modification, and goal setting 
and action planning (preliminary data described below). The goal of the current study is 
to explore the feasibility and acceptability of a rehabilitation intervention that 
blends these restorative and supportive strategies to reduce disability for older 
adults with MM. Pilot testing of the program and solicitation of stakeholder input will 
allow us to prepare for future efficacy trials by identifying appropriate procedures for 
participant identification and recruitment, delivery of the intervention via clinic or 
telehealth, and identification of an adequate comparison condition.  
 
Preliminary Studies Supporting the Scientific Premise 
 
After conducting two descriptive studies examining disability and participation among 
older adult cancer survivors,[19, 20] our team developed and pilot tested an intervention, 
referred to as the Health Through Activity (HTA) program, to reduce disability by 
fostering activity engagement among older adult cancer survivors. The HTA program 
was patient-centered, as participants self-selected activities they wanted to engage in and 
were taught to create an activity prescription for themselves. The occupational therapist 
delivering six individualized intervention sessions guided each participant to identify 
potential barriers and strategies to overcome these barriers. Participants were provided 
education (e.g., about activity adaptation or energy management) and adaptive equipment 

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(e.g., pedometer, reacher) as needed to address goals. Participants were also offered the 
chance to practice the activity of interest with the occupational therapist or to modify the 
environment to make it easier. This activity prescription process was repeated at each 
session, after debriefing about goal attainment and effectiveness of the previous week’s 
action plan. 
 
In the pilot study, participants most often set goals to increase exercise (44% of goals), 
improve instrumental activities of daily living and/or home management tasks (14%), and 
increase leisure activities (24%). Regarding treatment strategies, 77% of the 61 
participants chose to practice the activity with the occupational therapist, 42% requested 
a piece of equipment, and 11% modified the environment to increase activity 
engagement.[21] Participants set 63 long-term goals and met or made progress towards 
49 of them (full or partial goal attainment rate of 78%; full goal attainment rate of 
62%).[22] In terms of self-reported disability, the control condition (i.e., “usual care” that 
rarely included rehabilitation) showed no change over time whereas the HTA group 
demonstrated improvements over time (effects were not statistically significant as study 
was not powered for efficacy testing).[23]  
 
Thirty-three of the 61 participants in the HTA pilot study were living with incurable 
hematological malignancies such as multiple myeloma. Exploratory subgroup analyses 
revealed that this group of participants experienced the greatest benefit from the HTA 
program. Content analysis of the intervention sessions revealed that participants with 
advanced/metastatic cancer more often requested education about how to improve 
performance in activities such as exercise, sleep, and energy management.[24] They 
reported strong interest in increasing activity engagement that would build strength and 
resilience for future treatment changes or cycles. While the participants with metastatic 
disease reported physical impairments of fatigue (50% of participants) and pain (42%) as 
barriers to activity engagement, they also reported environmental barriers (weather 58%; 
and environment not conducive 17%) and lack of time for activity engagement 
(58%).[24] 
 
Refinements of the original HTA program for the current study 
 
Considering the importance of exercise to maintaining physical function among 
individuals with MM, we expect that the addition of a customized exercise prescription 
will increase the potency of the intervention. Exercise prescription that is individualized 
to reduce risk of injury and accommodate/address any long-standing physical 
impairments is important for individuals living with MM.[18, 25-27] Therefore, we will 
modify the HTA intervention so that it is co-delivered by an occupational therapist and 
physical therapist, where the former focuses upon fostering activity engagement via 
activity prescription (i.e., a supportive strategy to reduce disability) and the latter focuses 
upon fostering exercise engagement via exercise prescriptions (a restorative strategy to 
reduce disability).  
 

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While the home-based pilot study provided the opportunity for environmental 
modification and practice of an activity within the home setting, this delivery model may 
reduce the scalability of the intervention. However, our pilot data suggest that the 
intervention has the potential to be delivered in an outpatient venue, as only three 
participants chose to modify their home environment. Additionally, when participants 
chose to practice an activity with the occupational therapist, it most often involved 
exercise (e.g., walking), which could occur within an outpatient setting. As such, we will 
explore the feasibility of providing the revised HTA intervention within the outpatient 
environment of the MGH Institute of Health Professions (MGH IHP) (i.e., within the 
IMPACT Practice Center, a pro bono therapy clinic at MGH IHP, or within MGH IHP 
clinical research laboratories).   
 
Early observations of our study indicate that attending in-person study visits may be a 
barrier for some participants. A few eligible participants have expressed a desire to 
participate but have chosen not to enroll due to difficulty attending in-person study visits. 
Furthermore, due to the immunocompromised condition of our participants, each of the 
three enrolled participants have had to cancel/reschedule in-person study visits because of 
illness, resulting in interrupted study participation. We anticipate that this is a barrier we 
may regularly encounter in this population. Enrolled participants and those choosing not 
to enroll have voiced that telehealth study visits would be appealing. Finally, our 
experience delivering the revised HTA intervention to the initial study participants has 
revealed the potential feasibility of delivering the intervention via telehealth (except for 
Study Visits 1 and 6 which include physical therapy tests/examination, necessitating in-
person study visits). We feel that providing participants with a telehealth option may 
enhance study enrollment and retention without compromising the integrity of the 
intervention. This would potentially improve scalability/implementation of the 
intervention should it prove to be efficacious. As such, we will explore the feasibility of 
providing an option for participants to receive the revised HTA intervention via telehealth 
technology 
 
 
3.0 
Inclusion and Exclusion Criteria 
 
3.1. Population and Sample and Screening. The target population is up to 20 adults 
≥18 years of age, diagnosed with multiple myeloma currently receiving 
maintenance therapy. During in-person or telephone screening, study staff will 
describe the study, screen for eligibility, and answer questions. Potential 
participants will be provided with the consent form to review. If interested in 
participating, the research coordinator or other study staff will use a standardized 
screening form to review the following inclusion and exclusion criteria. 
 
3.2. Eligibility Criteria 
 
Inclusion Criteria: Potential participants will be adults 
• ≥18 years of age,  

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• 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?”[28] 
 
Exclusion Criteria: Participants will be excluded if their medical record documents 
or they report:  
• 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.[30]  
Rationale: We are excluding people with new onset or recent increase in bone 
pain as this may suggest progression of disease or acute change in bone integrity. 
We are excluding people with uncontrolled pain as it could be indicative of bony 
disease process warranting further medical attention. Additionally, it would be 
best to ensure that pain is being optimally managed before starting any new 
exercise program. We are excluding people with history of fracture without 
fixation as exercise with unstable bony lesions increases the risk of injury. If 
people are excluded for these reasons, we will suggest that they discuss this with 
their physician. 
3.3. We will not be enrolling the following vulnerable populations: adults unable to 
consent, individuals who are not yet adults [infants, children, teenagers], 
pregnant women, prisoners. 
 
4.0 
Study-Wide Number of Subjects 
 
We aim to recruit up to 20 participants for this study. 
 
5.0 
Study-Wide Recruitment Methods 
 
Participants will be recruited from the Massachusetts General Hospital (MGH) Cancer 
Center’s Center for Multiple Myeloma in Boston, Massachusetts. This Center serves a 
diverse population and provides comprehensive treatment for all stages of multiple 
myeloma. Consecutive sampling of the outpatient service will be performed to minimize 
bias through the inclusion of all eligible patients.[31] 
 

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Prior to initiating the trial, we will meet with the referring clinicians to review the study 
and the recruitment and enrollment procedures. These procedures mirror those 
established and successfully utilized by the Cancer Outcomes and Research Education 
(CORE) research program at MGH Cancer Center.  
 
We request a partial HIPAA waiver to allow us to review the medical records of patients 
with multiple myeloma coming for outpatient appointments to pre-screen them for 
potential eligibility.  
 
The research coordinator will review the weekly appointment schedule of referring 
clinicians. The research coordinator will communicate with the clinicians (i.e., the 
physicians and advanced practice providers who care for the patients in the outpatient 
setting) via email, through the electronic health record, or verbally (based on clinician 
preference) to notify them that the patient may be eligible for the study and inquire about 
concerns regarding their participation. If the clinicians voice objections to the patient 
enrolling in the study, the research coordinator will document the reason and not 
approach those individuals. If the clinicians have no objections, the research coordinator 
will approach patients either in person, by telephone (using the included eligibility 
screening script), or will send a letter by mail or Patient Gateway (using the included 
template). In this communication, the research coordinator will inform the patient that 
their clinicians have indicated they might be eligible for this study and wanted to let them 
know about this study. Patients who were sent a letter will be asked to reply to the 
research coordinator either by phone or email if interested in learning more about the 
study. The letter includes text indicating that the research coordinator may also follow up 
with a phone call to see if they would like to learn more about the study. 
 
In person or via telephone, the research coordinator will provide the potential participant 
an overview of the study using the study brochure. If the person is interested in learning 
more, the research coordinator will proceed with the standardized screening questions 
(included in the initial IRB application) to determine eligibility. If the person is eligible, 
the research coordinator will either 1) provide a study iPad with an electronic version of 
the study consent form (eConsent) via REDCap (if obtaining consent in-person), or 2) 
send a private link to the eConsent form via REDCap (if obtaining consent over the 
phone), so that the potential participant can view the consent form as the research 
coordinator reviews it with them. A paper-based consent will remain an option as well. 
The research coordinator will review the consent document which details the nature of all 
study procedures, encouraging the person to ask questions to clarify any confusion. If the 
person wants to enroll, the coordinator will obtain written informed consent from the 
patient and provide them with a dually signed digital copy of the consent form. This 
process will be managed via REDCap. 
 
The research coordinator will create a database with the names and details of all 
individuals contacted by the study team so that participants who decline or who are not 
eligible are not re-contacted. Names will be removed from the database upon completion 
of study recruitment. 

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6.0 
Study Timelines 
 
Estimated study dates: 
• Pilot Start Date: 9/1/22 
• End of recruitment and enrollment: 8/31/24 
• Primary Analyses Complete Date: 12/31/25 
Participation timeline. Participants in this study will be asked to attend 6 weekly study 
visits (rescheduled if requested for participant convenience). Following the final study 
visit, participants will be contacted by telephone for a follow up assessment and 
interview. Therefore, participation in this study may last between 3 and 4 months. 
 
7.0 
Study Endpoints 
 
7.1. Primary study endpoints are the feasibility of recruitment and data collection 
activities. Feasibility of enrolling and retaining participants with multiple 
myeloma into a pilot test of the refined HTA intervention delivered from MGH 
IHP and via telehealth will be measured by the following rates: # screened, # 
found eligible, # enrolled, # intervention visits completed, and # surveys 
completed. 
7.2. Secondary study endpoint is the acceptability of the Health Through Activity 
program. Acceptability of the Health Through Activity program will be assessed 
utilizing semi-structured interviews to solicit feedback on the utility of HTA and 
recommendations for modifications to the intervention.  
 
8.0 
Procedures Involved 
 
8.1. Design. This is a single arm feasibility study of the Health Through Activity 
rehabilitation intervention for people living with multiple myeloma. The goal is 
to determine if we can feasibly deliver the program from MGH IHP (i.e., out of 
the IMPACT Practice Center or clinical research laboratories) and via telehealth. 
This feasibility study will allow us to obtain feedback from stakeholders that we 
will use to refine the procedures and program in future testing. 
 
8.2. Philosophy and Treatment Procedures. 
Rehabilitation is an active, collaborative pursuit in which the therapist serves as a 
guide as the patient engages the mind, body and spirit in an activity. The Person-
Environment-Occupation (PEO) Model[32] is one OT practice model. The PEO 
model encourages therapists to consider the transactions between the person, 
environment, and valued activities and to maximize the congruence between the 
three elements in order to reduce disability. The PEO model suggests three 
potentially complementary courses of action in response to disability. When 
someone is unable to perform a valued activity, the individual can: (1) change 

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something about his or her personal skills and capabilities (e.g., improve strength 
through exercise), (2) change the environment in which the activity is performed 
(e.g., improve lighting or reduce ambient noise), or (3) change the nature of the 
activity itself (eliminate steps of an activity or utilize adaptive equipment). The 
use of these complementary approaches is determined in collaboration with the 
participant, as each approach has a benefit/effort ratio for an individual.  
 
After enrolling, participants will be asked to complete baseline study surveys 
(described below in section 8.3) electronically using a browser-based research 
electronic data capture (REDCap). Participants will also schedule their first in-
person study visit. 
 
Feedback from the first three participants in our study suggest that some 
participants may be interested in receiving the educational workbook (described 
below) prior to attending Study Visit 1. Therefore, after enrolling and completing 
baseline surveys, participants will be offered the option to be sent an electronic 
(PDF) version of the workbook. 
 
At the first in-person study visit, participants will be met individually by a 
licensed occupational therapist, and a licensed physical therapist, at the MGH 
Institute of Health Professions in the Charlestown Navy Yard. The therapists will 
begin Study visit 1 by providing education (using an educational workbook) 
regarding the importance of daily activity and exercise in the maintenance of 
physical, cognitive, and emotional health. After discussing ways in which cancer 
treatment can affect daily activities, participants will discuss their current activity 
level and any pre-existing exercise routine and identify priorities for intervention 
(described as individual activity goals in Measures). The physical therapist will 
then repeat the safety screening (i.e., review contraindications to exercise as per 
exclusion criteria, screen for current presence and severity of pain, and discuss 
participant concerns regarding participation in exercise) and administer the Short 
Physical Performance Battery (SPPB), a 2-Minute Walk Test (2MWT) and the 
Self-Efficacy with Exercise (SEE) Scale Questionnaire. Based on the results of 
the SPPB, 2MWT, and SEE Scale. The physical therapist will prescribe a 
customized exercise program consisting of aerobic, resistance, and balance 
exercises. Exercises will be based on clinical practice guidelines that foster safe 
exercise engagement and delineate contraindications for exercise for individuals 
with multiple myeloma. Individualized exercise instructions will minimize risk 
of injury by emphasizing postural alignment, controlled movements, utilization 
of proper technique, fall risk reduction, and by considering participants’ 
individual risk factors (e.g., lytic lesion location, peripheral neuropathy).[18, 33] 
 
In each of study visits 2-6, the therapists will lead the participant through an 
activity planning process to identify activity and environmental adaptations to 
support engagement in 1) a specific daily activity of the participant’s choice and, 
2) the execution of the individualized exercise prescription. An “activity 

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prescription” (i.e., goal and action plan) is collaboratively generated to allow the 
participant to complete the activity and exercise program in the coming week. 
The action plan is practiced with the therapist present whenever feasible and the 
individualized exercises are first demonstrated by the therapist with return 
demonstration by the participant.  
 
The HTA Treatment Manual describes the theoretical base of the intervention 
and the structure of the six sessions. The six sessions ideally occur once a week 
(rescheduled as needed for participant convenience) and last 50 to 75 minutes. 
Sessions will be individually delivered. Sessions 1 and 6 will occur in-person at 
MGH IHP either in the IMPACT Practice Center or in the clinical research 
laboratories. Participants will be given the option of completing study visits 2-5 
in-person at MGH IHP or virtually via telehealth technology. 
 
8.3. Measures 
 
Sociodemographic and Clinical Characteristics to Describe the Sample 
 
A standardized survey will be used to collect data on participants’ age, race, 
ethnicity, employment status, level of education, marital status, household 
income, living situation, gender identity, and clinical comorbidities[34]. We will 
also collect baseline clinical, disease, and treatment information via chart review 
such as: Eastern Cooperative Oncology Group (ECOG) performance status, date 
of initial diagnosis of multiple myeloma, chemotherapy treatment regimen, and 
date started on maintenance therapy. 
 
Disability 
 
The Late-Life Function and Disability Instrument (LLFDI). The LLFDI is a self-
report assessment developed for use in community-dwelling older adults.[35, 36] 
The function subscale (32 items) measures limitations in specific physical tasks 
of daily life and the disability subscale (16 items) measures inability to 
participate in major life tasks. When used with adults with a mean age of 80 
years (SEM = 0.4 years), the scores were moderately correlated with a short 
physical performance battery, gait speed, and lower extremity function.[37] One 
week test-retest reliability of the function subscale had an intraclass correlation 
coefficient (ICC) of 0.96. One week test-retest of the disability subscale 
demonstrated an ICC of 0.68 for frequency scores and 0.82 for limitation scores. 
 
Activity Level  
 
Activity Card Sort modified (ACSm).[38] The Activity Card Sort [39] was 
developed to measure the instrumental, leisure, and social activity levels of older 
adults and modified for use with cancer survivors [40]. The ACSm provides a 
total score and four domain scores: instrumental activities (cooking meals, 

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paying bills, driving), low physical demand leisure (e.g., reading, doing puzzles, 
using the computer), high physical demand leisure (e.g., golfing, woodworking, 
gardening), and social activities (e.g., eating at a restaurant, going to parties, 
going to a place of worship). While originally developed as a manual card sort 
using labeled, pictorial depictions of the 80 activities, the tool demonstrates 
adequate reliability without the use of the picture cards [40, 41]. Activity Card 
Sort scores have been positively associated with quality of life [40, 42], health, 
and functioning [41]. 
 
Individual Activity Targets (IAT): During the first session, the occupational 
therapist elicits the participant’s individual activity goals. The participant rates 
each activity with Likert scales for three characteristics: frequency of current 
performance (very often, often, once in a while, almost never, never), importance 
of the activity (1-10), and satisfaction with the activity (1-10). These ratings were 
used in the pilot study and provided a simple and pragmatic tool for assessing 
individualized outcomes 
 
Quality of Life and Cancer-Related Fatigue 
 
Functional Assessment of Chronic Illness Treatment – Fatigue (FACIT-F). The 
FACIT-F is a 41-item questionnaire consisting of the FACT-G (28 items), which 
measures health-related quality of life covering four domains of well-being 
(physical, social/family, emotional, functional), plus 13 fatigue-specific items. 
The FACIT-F has robust psychometric properties with excellent test-retest 
reliability (ICC=0.91),[43] validity, and the ability to detect change over time 
among older adults with cancer.[44-46] A cut off score of 34 is diagnostic of 
cancer-related fatigue, based on a 0-52 total available score for the fatigue 
subscale.[47] 
 
Balance, Gait Speed, and Functional Strength  
 
Short Physical Performance Battery.[48] The Short Physical Performance 
Battery (SPPB) is a multidimensional tool used to assess lower extremity 
function and is strongly associated with self-reported disability among older 
adults.[48] The SPPB assesses the ability to stand for ten seconds with the feet in 
three different positions (i.e., balance), time to walk 3 or 4 meters (i.e., gait 
speed), and the time it takes to rise from a chair five times (i.e., functional 
strength).[48] The SPPB is highly recommended as a measure of functional 
mobility by the EDGE Task Force of the Academy of Oncologic Physical 
Therapy of the American Physical Therapy Association due to its ease of 
administration and scoring, excellent test-retest reliability (ICC = 0.81-0.91) and 
sensitivity to detect change (MCID = 0.5 points).[49, 50] Established normative 
data and cut-off scores will assist in identifying participants who may be at 
increased risk of mobility disability.[50, 51] The SPPB produces a composite 
score, ranging 0-12, with higher scores indicating better function. 

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Aerobic Capacity 
 
2-Minute Walk Test.[52] The 2-Minute Walk Test (2MWT) is a measure of 
aerobic capacity that assesses walking distance covered in two minutes. Among 
older adults, the 2MWT has excellent test-retest reliability (ICC=0.95) and 
established normative data (150.4 meters) and MDC (12.2 meters).[52] The 
2MWT correlates highly with the 6-Minute Walk Test (r = 0.93) and the Timed 
Up and Go Test (r = - 0.87),[52] while there is evidence that the 2MWT is more 
tolerable than the 6-Minute Walk Test among older adults.[53] 
 
Exercise Self-Efficacy 
 
Self-Efficacy for Exercise (SEE) scale.[54] The SEE scale consists of nine 
potential exercise barriers and asks the individual to rate their confidence on a 0 
(not confident) – 10 (very confident) scale that they could exercise for twenty 
minutes, three times per week, given each barrier (maximum score of 90 
indicates highest exercise self-efficacy). Among older adults, the SEE scale has 
been shown to have excellent internal consistency (Cronbach'sα= 0.92) and SEE 
scale scores significantly predict exercise activity.[54] Although the SEE scale 
has not been validated in samples of survivors with CRF, a validated measure of 
ESE in this population does not currently exist, and we feel that the nine barriers 
appropriately represent scenarios that our participants may regularly encounter. 
 
 
 
Acceptability of the intervention 
 
Satisfaction survey. We will use a 7-item survey that we developed for previous 
studies to assess satisfaction with: the intervention, the therapists, the number 
and length of sessions, the helpfulness and importance of the intervention 
content. These items are rated on a 5-point Likert scale with verbal descriptions. 
The final question asks if the participant would recommend the intervention to 
another person who was trying to be active while living with multiple myeloma. 
 
Semi-structured interview. Dr. Wechsler will train the project coordinator to 
conduct the semi-structured interview. During these interviews, the coordinator 
will solicit feedback on the utility of HTA and recommendations for 
modifications to the intervention. While the guide serves as a starting point for 
the conversation, it will evolve to be responsive to the accounts being obtained 
both from the interviews up to that point and the account emerging in the 
ongoing interview. We expect the interview to last approximately 20 minutes. 
With participant permission, the interview will be audiorecorded and transcribed 
verbatim. Once the transcript has been proofread, the audiorecording will be 
deleted. 

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We will also conduct one semi-structured interview with each interventionist who 
delivered the HTA program. The interventionists are valuable stakeholders to 
provide insight into feasibility and acceptability of this program and to help the 
study team determine issues related to scalability, implementation, and potential 
modifications required for future iterations. These semi-structured interviews will 
be conducted individually by a research coordinator who was not involved in 
delivery of the intervention to minimize risk of social desirability bias. An 
interview guide will serve as a starting point for the conversation but will evolve 
as described above to be responsive to the information being gathered. 
Verbal consent will be obtained from each interventionist prior to the 
interview, including permission to audio-record the interview. Audio-
recorded interviews will be transcribed verbatim and the audiorecording 
will be deleted once the transcript has been proofread. 
 
Data Collection  
The table below depicts the schedule and the study staff who will administer the 
instruments (PC = Project Coordinator, PT = physical therapist, and OT = 
Occupational therapist). The project coordinator will collect the data by 
telephone at baseline (Time 1), after completion of the intervention (Time 2) and 
six weeks after completion of the intervention (Time 3). The occupational and 
physical therapists will collect data in person during sessions 1 and 6.  
 
Variable 
Instrument 
# of 
items 
Administered 
by  
Time 
1 
Session 
1 
Session 
6 
Time 
2 
Time 
3 
Demographics 
and 
Comorbidities 
Survey 
 
 
29 
PC 
X 
 
 
 
 
Function and 
Disability 
LLFDI 
32 
16 
PC 
X 
 
 
X 
X 
Activity level 
ACSm 
IAT 
80 
variable 
PC 
OT 
X 
 
X 
 
X 
X 
X 
Quality of 
Life and 
fatigue 
FACIT-F 
40 
PC 
X 
 
 
X 
X 
Exercise Self-
Efficacy 
SEE Scale 
9 
PC 
X 
 
 
X 
X 
Acceptability 
Survey and 
Interview 
7 
N/A 
PC 
 
 
 
X 
 
Balance, gait, 
and strength 
SPPB 
N/A 
PT 
 
X 
X 
 
 
Aerobic 
Capacity 
2MWT 
N/A 
PT 
 
X 
X 
 
 
 
9.0 
Data Banking* 
 
No data will be used for anything beyond the analyses described in this protocol. 
 

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10.0 Data Management* and Confidentiality 
 
10.1. Analysis.  
Aim 1: To evaluate the feasibility of enrolling and retaining participants with 
multiple myeloma into a pilot test of the refined HTA intervention, delivered 
from MGH Institute of Health Professions (i.e., within the IMPACT Practice 
Center or clinical research laboratories) and via telehealth technology. 
 
Aim 2: To evaluate the feasibility of administering the outcome assessment 
battery that includes patient-reported outcomes of disability, activity level, 
quality of life, fatigue, and exercise self-efficacy, and performance-based 
outcomes of balance, gait speed, and strength. 
 
For Aims 1 and 2, we will calculate the following feasibility statistics: 
• Screening rate: Number patients screened/ Number patients identified 
as potentially eligible 
• Eligibility rate: Number patients screening positive & eligible / Number 
screened 
• Enrollment rate: Number participants enrolled / Number screened 
positive & eligible 
• Intervention completion rate: There are two metrics for this a) Number 
participants completing 6 sessions of the HTA intervention/Number of 
participants enrolled; and b) Number of completed sessions per 
participant 
• Assessment completion rate: Number participants completing each of 
the three study assessments/Number of participants enrolled 
 
Thresholds for assessing feasibility:  
• The screening rate is influenced both by staffing efforts to reach 
patients and patients’ willingness to engage in screening in person or by 
telephone. Screening rate of at least 75% will indicate feasibility. 
• The eligibility rate is influenced by how many people in the clinical 
population are experiencing disability. Based on our pilot study, we 
expect this rate to be at least 35%. 
• The enrollment rate is one of the most important markers of feasibility 
as it reflects how many patients experiencing the targeted problem 
choose to enroll in the study. Enrollment rate of at least 75% will 
indicate feasibility. 
• The intervention completion rate is influenced by the level of burden of 
the intervention, the health status of the participants, and the perceived 
benefit of the intervention. In our pilot study, we had a 90% 
intervention completion rate when using the participants as the unit of 
analysis (i.e., the first metric listed above). However, in the pilot study, 
the therapist came to the participant’s home to deliver the intervention. 

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For this study, we will consider it feasible if 75% of participants 
complete all six sessions and if the mean number of sessions is greater 
than or equal to 4. 
• The assessment completion rate is influenced by the burden (time and 
cognition) involved, the perceived meaningfulness of items, and the 
flexibility of mode of completion (e.g., by computer, by telephone per 
preference). In our pilot we had a 80-90% assessment completion rate 
depending on study arm. For this study, an assessment completion rate 
of 85% will indicate feasibility. 
 
Aim 3: To assess the acceptability of the refined HTA intervention and 
assessment battery and utilize stakeholder feedback to identify further 
modifications to enhance acceptability. 
 
For Aim 3, we will calculate descriptive statistics on the satisfaction survey 
data. We will also explore the interview data. All interviews will be audio-
recorded and professionally transcribed. Immediately following the interview, 
the coordinator will listen to the recording and take detailed field notes that 
will describe the content and context of the interview, ending with a summary 
of stakeholder opinions and recommendations. Field notes will also provide 
details about the evolution of the interview guide and questions and themes 
that seem important as the interviews unfold. Transcripts, field notes, and 
interventionist field notes will be imported into NVivo for qualitative analysis. 
 
Drs. Lyons and Wechsler will independently read the transcripts and field 
notes. Informed by the tradition of Miles and Huberman, we will code the data, 
then discuss and compare our codes to create a formal codebook with 
operational definitions. Coding is an iterative process that involves labeling 
segments of data. Some codes will reflect concepts introduced by participants, 
and many will reflect my own areas of interest such as difficulties with the 
intervention, or positive experiences within the intervention. We will then look 
within and across coded texts to extract converging themes and reach 
consensus on principal themes. We will use the themes to modify the manual 
in consultation with the full research team. 
 
Thresholds for assessing acceptability: In terms of the satisfaction survey, any 
item that generates a mean score of < 4 will trigger consideration of making a 
modification to the treatment manual or study procedures. We will explore the 
interview data to help us understand what may be driving the lower satisfaction 
rating and brainstorm potential modifications that could be adopted in 
response. Independent of the survey scores, we will also use the interview data 
to identify potential changes. The decision to modify the protocol for 
subsequent studies will be informed by both the number of people expressing 
the opinion and the salience or potency of the concern e.g., a recommendation 
to add an education topic to the patient education manual or a 

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misunderstanding by even one participant could lead us to edit the study 
materials or procedure.  
 
 
10.2. Sample Size Determination. Consistent with the intent of a feasibility study [55, 
56], this exploratory analysis is primarily intended to develop the intervention 
and evaluate the feasibility and acceptability of the refined HTA program and is 
not powered to test effectiveness hypotheses. Based upon our previous studies 
in developing and testing behavioral interventions [57-59], we expect that 20 
participants will be feasible to recruit within a 12-month period and will give us 
rich data to determine the feasibility and acceptability of the intervention. 
 
10.3. Data Storage. All participant information and study source documents 
will remain confidential and be accessible only to study staff. Paper 
copies will be kept in locked file cabinets of locked offices belonging to 
Dr. Lyons. Electronic files will be stored on secure institutional 
computers using MGH Dropbox. All study data will be maintained in the 
MGH version of REDCap. REDCap is a free, secure, HIPAA-compliant 
web-based application hosted by the MGB Research Computing, 
Enterprise Research Infrastructure & Services (ERIS) group.  
 
10.4. Data Security. Participant data will be collected using MGH REDCap. 
All participants will be assigned an id number and only one password-
protected file will link the name with the study id. Participants’ responses 
to survey questions will remain confidential. Study staff undergo training 
on study procedures as well as data management to ensure data security 
and patient confidentiality (e.g., good practice of locking computers 
before stepping away from desk, not using names where outside team 
members could hear). 
 
11.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
 
The study will be monitored to ensure that it is conducted in conformance with the 
monitoring plan to assess continued compliance with the protocol and recognized 
Good Clinical Practices (GCP).  
 
The PI (Dr. Lyons) will verify that study records are adequately maintained, that 
data are reported in a satisfactory manner with respect to timeliness, adequacy, and 
accuracy, and that the investigative team continues to have sufficient staff and 
facilities to conduct the study safely and effectively.  
 
Data Safety and Monitoring Plan 

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The following procedures will be followed to ensure the safety of study participants 
and the validity and integrity of data.  
 
● Range of Safety Reporting: Drs. Lyons and Wechsler will debrief (with the 
interventionists and/or observing students at the IMPACT Practice Center) after 
every session to explore and document the session content and any safety concerns. 
This includes reports of Adverse Events noted by the interventionists or the 
research coordinator. 
 
● Data Repository: The research team has established procedures for data collection 
and management. Dr. Wechsler will oversee all aspects of data collection for the 
study, and the research coordinator will have the operational responsibility of data 
management. Specifically, the research team will develop a study-specific data 
management protocol and standard operating procedures for the creation and 
testing of all study forms, data collection, quality control, and data extraction. All 
data management activities will utilize REDCap.  
 
● Serious Adverse Events (SAEs): Given that this is a rehabilitation study in a 
population at risk for disease progression and death due to their medical condition 
(unrelated to study procedures), we do not expect any SAEs to be related to the 
study. Thus, SAEs will not be reported to the IRB, unless they are potentially 
related to the study procedures. Any SAEs related to the study procedures should 
be entered into the Electronic Data Capture (EDC) system within three (3) business 
days of the site becoming aware of the event.. If a SAE is reported, the MGH 
research team shall immediately conduct an evaluation of the SAE and will make a 
determination as to whether it meets the criteria for definition and for reporting to 
the IRB. Any reportable SAEs will be reported to the IRB as soon as possible, but 
in no event later than ten (10) working days after becoming aware of the event.  
 
● Non-Serious AE: The research team will review monthly summary reports of the 
numbers and rates of AEs by treatment group and study site. These reports will 
include types of events, severity, and treatment phase.  
 
● Relationship of SAE and AEs: the research team will assess the potential 
relationship of AEs or SAEs to the HTA intervention and classify the causality of 
the event according to the following definitions 
o Definitely Related:  An AE that has a strong causal relationship. An AE 
that follows a strong temporal relationship, follows a known response 
pattern, and cannot reasonably be explained by known characteristics of 
the subject’s clinical state or other therapies. 
o Probably Related: An AE that potentially has a causal relationship. The 
AE has a reasonable temporal relationship and alternative etiology is less 
likely compared to the potential relationship to the HTA program. 

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o Possibly Related: An AE that potentially has a causal relationship. The 
AE has a reasonable temporal relationship to the use of the investigational 
mobile apps but alternative etiology is equally likely compared to the 
potential relationship to the HTA program. 
o Not Related: An AE without any apparent causal relationship. The AE is 
due to the underlying disease state or is due to concomitant medication or 
therapy not related to the HTA program. 
o Unknown Relationship: If the AE cannot be determined to have a causal 
relationship, it will be classified as unknown. 
 
● Other Safety-Related Reports: The research team will review weekly summary 
reports of treatment retention and reasons for dropout. 
 
 
Monitoring of Data Quality by the Research Team: 
The research team (at each participating institution) will review the following items 
on weekly basis to ensure data quality and completeness: 
● Total enrollment compared with anticipated enrollment 
● Number of ineligible patients registered 
● Proportion of missing participant-reported outcomes 
● Proportion of other missing data 
● Number of participants lost to follow-up 
● Number of participants completing the study 
 
12.0 Withdrawal of Subjects 
 
12.1. When and How to Withdraw Subjects. Throughout the study, participants will be 
aware that their participation in the study is voluntary. In general, participants will 
be focusing on engaging in activities of their choosing with the goal setting and 
action planning involving detailed ways to maximize the safety of activity 
engagement and minimize chance of injury, e.g., risk of falling during exercise. 
As such, there are very few times when it would be necessary to withdraw a 
participant from the study. That said, there are times when exercise is 
contraindicated such as in the presence of unstable bony metastases, increased pain 
(beyond normal expected response to exercise), altered neurologic presentation 
(e.g., diminished reflexes, bowel/bladder changes), or myelosuppression (e.g., 
thrombocytopenia/anemia below thresholds for safe exercise).[18, 33, 60, 61] 
Should those situations occur, participants will be advised to discontinue exercise 
until the situation resolves. Monitoring the number of times that exercise 
recommendations need to be suspended will inform us as to the feasibility and 
acceptability of the intervention for this population. As such, participants may be 
advised to discontinue exercise, but will not be withdrawn from the study unless 
they ask to be withdrawn. 

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Our team continues to attempt to contact participants for each session and study 
assessment unless and until they ask us to stop/express the desire to withdraw. 
Each study contact is an extension of informed consent where participants are told 
what is occurring, what happens next, and that their participation is voluntary. 
When we are unable to reach participants by telephone for at least 30 days we send 
a letter conveying our attempts to reach them and ask them to contact us to 
continue with study activities or withdraw, as they prefer. 
 
12.2. Data Collection and Follow-up for Withdrawn Subjects. Participants who choose 
to withdraw from the intervention will be asked if they are amenable to continued 
participation in the data collection with the research coordinator or if they wish to 
completely withdraw from the study. The research coordinator will inform the 
participant that either choice is acceptable and completely up to them. 
 
13.0 Risks to Subjects 
 
There are three potential risks involved in this study: (1) the risk of hurting oneself 
when trying to exercise or increase activity level (e.g., falling while exercising or 
performing home management tasks); (2) the risk of distress while talking about 
disability and quality of life; and (3) risk of loss of confidentiality. The level of risk is 
generally low and strategies to minimize risks are incorporated into the HTA treatment 
manual and are addressed below. 
 
Risk of injury: The goal of the HTA intervention is to reduce disability by fostering 
engagement in exercise and valued activity. The intervention teaches participants 
to change aspects about themselves, the task, or how it is performed to engage in 
valued activities. Regarding the risk of injury, the HTA program includes action 
planning to increase the safety and success of activity engagement to minimize the 
chances of this risk. Furthermore, we will follow clinical practice guidelines that 
foster safe exercise engagement and delineate contraindications for exercise. 
Individualized exercise instructions will minimize risk of injury by emphasizing 
postural alignment, controlled movements, utilization of proper technique, fall risk 
reduction, and by considering participants’ individual risk factors (e.g., lytic lesion 
location, peripheral neuropathy).[18, 33] Patient educational materials will 
emphasize how to recognize abnormal responses to exercise and reasons to cease 
exercise and seek medical attention. Bidirectional communication with the 
participants’ medical team will ensure identification of and consensus regarding 
any necessary precautions or contraindications to exercise. The therapists are 
knowledgeable in site-specific procedures to summon emergency medical help. If 
a participant sustains an injury while enrolled in the study, they will be assisted and 
instructed to seek medical attention commensurate to their injury including but not 
limited to presenting to the emergency room and/or following up with their 
oncologist for further evaluation. For virtual study visits, participants will be 
provided with a virtual handout depicting each exercise and the physical therapist 
will provide specific exercise instructions and explicit guidance to maintain safety 

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within the participant’s environment (e.g., clearing space to avoid tripping on 
clutter, standing next to a countertop to maintain balance). As with in-person study 
visits, exercises will be based on the results of the participant’s physical 
examination during the in-person Study Visit 1, reducing the chance of prescribing 
exercises that are beyond their capacity or that will jeopardize their safety. 
Regarding risk of injury during a virtual study visit, therapists will adhere to 
IMPACT Practice Center policies regarding recognizing and responding to health 
emergencies during telehealth care. Therapists will confirm and document the 
participant’s location at each visit in case emergency services need to be 
summoned. If an injury occurs and it is determined that emergency care is required, 
the therapists will call 911 or, if others are present with the participant at their 
location, will advise the individual present to call 911. Therapists will help provide 
the 911 operator with necessary information and will stay on the virtual visit until 
emergency medical services arrive at the participant’s location. 
Risk of distress: This is somewhat of a self-correcting problem because the objective 
of HTA is to provide a structured process to help people find ways to increase 
activity engagement. The interventionists are trained to validate feelings of 
frustration and distress while re-directing the participant to actionable ways to make 
immediate progress. Likewise, the research coordinators who administer the 
outcome assessment are also trained in listening for signals of distress (e.g., long 
pauses, weeping) and are trained handle distress tactfully (e.g., do not indicate 
verbally or non-verbally that they are uncomfortable with participant distress) and 
to remind the participants that they can discontinue the surveys at any time. The 
outcome assessments of disability, activity engagement and quality of life do not 
contain many emotionally charged items and we find that most participants voice 
an appreciation for being asked to consider these aspects of their lives as opposed 
to being upset by them. If a participant becomes very upset, study staff will help 
them find a counselor and/or provide them with mental health crisis resources 
available through MGB and the Massachusetts Department of Mental Health. 
 
Risk of privacy loss: Finally, to address a low-level risk of loss of privacy, 
participant confidentiality will be strictly protected. Hard copies of data will be 
maintained in locked files that can only be accessed by study personnel. Data forms 
will be identified using an identification (ID) number only. Access to the list cross-
tabulating ID numbers with participant names will be kept in a password-protected 
data file following the RISO recommendations. All computer systems and 
programs will be password protected, and all electronic communications of study 
and other confidential information will be encrypted. Good computer security 
practice (shutting down computers after work hours, restricting physical access to 
machines, prohibition of password sharing) will be required of all study personnel. 
Virus protection software is installed on each study computer. The virus detection 
tools are used, maintained, audited and, if necessary, updated on all computers and 
pathways into the system.  Redundant backups allow for quick restoration of data 
in the unlikely event that a hardware failure or security breach occurs.  
 

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14.0 Potential Benefits to Subjects 
 
Given the evidence regarding the ability of exercise to improve strength and aerobic 
capacity and the mood-lifting benefits of engaging in valued activities, it is possible 
that participants will experience improved physical and emotional well-being as a result 
of their participation in the study. However, the purpose of the study is to determine if 
the intervention is feasible and acceptable and to prepare the intervention and the team 
for full-scale efficacy testing, should it be warranted, so there may not be a benefit to 
participants on an individual level. 
 
15.0 Community-Based Participatory Research* 
To date, this line of research is best described as “community-informed” as opposed to 
“community-engaged research.” The intervention was initially developed by Dr. Lyons 
(PI) in response to feedback from hematologists and patients living with metastatic 
disease that more interventions are needed that help people stay active and engaged in 
life while living with incurable disease. By conducting semi-structured interviews, we 
are soliciting the input of participants to help us refine and improve the program. Prior 
to subsequent studies, we will seek out more input from the community to establish 
feasible procedures and assessments (e.g., through use of a community-engaged studio 
method).  
 
16.0 Sharing of Results with Subjects* 
Participants will be asked if they would like to receive a handout describing the 
results of the study. Individual data will not be provided to the participant nor 
to the referring physician. 
 
17.0 Setting 
 
Participants will be recruited from the MGH Cancer Center’s Center for Multiple 
Myeloma in Boston, Massachusetts. In-person study visits will take place at the 
IMPACT Practice Center (IPC) or clinical research laboratories on MGH Institute of 
Health Professions (IHP) campus in the Charlestown Navy Yard in Boston, MA. The 
two buildings that house the IPC and clinical research laboratories are directly adjacent 
to each other and share a parking lot. The IPC is MGH IHP’s pro-bono clinic. The IPC 
provides members of the community with interprofessional clinical services including 
occupational and physical therapy. The IPC is also a vehicle for clinical education 
as MGH IHP students have opportunities to observe and participate in both 
clinical care and clinical research being conducted within the IPC. In this study, 
students enrolled in the occupational and physical therapy programs will be 
observing participants’ study visits either in person or remotely by video 
observation rooms available within the IPC. Students will not be delivering study 
interventions. The therapists will orient the students to the study and will debrief the 
students following each study visit. 

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Participants will have the option of completing study visits 2-5 virtually via telehealth 
technology. This option will allow participants to engage in the study from the 
comfort of their homes, potentially reducing a barrier to participation. This option 
may prove to be beneficial as therapists will be able to provide participants with 
explicit guidance regarding their home environment including modifications to 
increase safety or ability to engage in meaningful activities. 
 
18.0 Resources Available 
18.1. Dr. Wechsler is a doctorally-prepared physical therapist licensed to practice in 
Massachusetts. Dr. Lyons is a registered occupational therapist licensed to practice 
in Massachusetts. Drs. Lyons and Wechsler have dedicated FTE to complete the 
study activities. 
Dr. Lyons has been principal investigator for supportive and rehabilitative studies 
for over 13 years and has written procedure manuals and trained and managed 
study coordinators for 19 years. Dr. Lyons is a member of the MGH Cancer 
Outcomes Research and Education Program (CORE). CORE has extensive 
experience conducting multi-site randomized clinical trials of supportive care 
interventions in oncology and has the necessary expertise to ensure the success of 
the proposed project. The CORE Program members, including co-investigator Dr. 
El-Jawari, have provided guidance according to clinical trial procedures that have 
been maximally effective here at MGH.  
The study team will meet weekly to identify and problem-solve any study issues. 
All coordinators complete CITI training and study- specific training before 
initiating work on the study. 
 
18.2 Patient population. At MGH, the clinicians treat approximately 100 patients with 
a new diagnosis of multiple myeloma per year and care for over 500 patients living 
with MM and therefore we are confident in our ability to recruit for this study. 
 
18.3 Facilities. The IMPACT Practice Center (IPC) is managed by the IPC Manager, 
and follows MGB rules and guidelines for client-centered care and safety 
protocols.  All licensed and supervising IHP faculty, staff, researchers, and 
students who see clients or perform research are required to complete MGB 
compliance and safety protocols, as well as a center orientation and attestation of 
the manual, which outlines the IPC standard operating procedures. The IPC is 
accessible with universal design.  The IPC has private rooms to ensure study 
participant confidentiality, and also has first aid kits and AED devices should an 
emergency occur. The emergency policy is to first call MGB Security at 5400 
before supporting any person who is experiencing an adverse event. The IPC has 
well-established protocols for providing telehealth using videoconferencing 

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technology including a detailed safety policy. Private rooms are available to 
maintain privacy during telehealth visits. 
 
The clinical research laboratories at MGH IHP have private rooms to ensure 
participant confidentiality, and also has first aid kids and AED devices should an 
emergency occur. As the laboratories are housed within the same campus as the 
IPC, the same emergency policies exist as described above. Private rooms with 
videoconferencing technology are available within the clinical research 
laboratories. When conducting a virtual study visit from the clinical research 
laboratories, study staff will adhere to IPC protocols for providing telehealth 
including the detailed safety policy. 
 
19.0 Prior Approvals 
The study was reviewed and approved by the ENRICH committee of the MGH 
Institute of Health Professions. All study team members will undergo the safety 
training required for all faculty and students who work at the IMPACT Practice 
Center. 
 
 
20.0 Recruitment Methods 
 
20.1. Describe when, where, and how potential subjects will be recruited. Prior to 
initiating the trial, we will meet with the referring clinicians to review the study 
and the recruitment and enrollment procedures. These procedures mirror those 
established and successfully utilized by the Cancer Outcomes and Research 
Education (CORE) research program at MGH Cancer Center. Recruitment 
procedures are detailed in section 5.0. 
 
20.2. Source of participants: Participants will be recruited from the Massachusetts 
General Hospital (MGH) Cancer Center’s Center for Multiple Myeloma in Boston, 
Massachusetts. This Center serves a diverse population and provides 
comprehensive treatment for all stages of multiple myeloma. Consecutive 
sampling of the outpatient service will be performed to minimize bias through the 
inclusion of all eligible patients.[31] 
 
20.3. Describe the methods that will be used to identify potential subjects. We request 
a partial HIPAA waiver to allow us to review the medical records of patients with 
multiple myeloma coming for outpatient appointments to pre-screen them for 
potential eligibility.  
 
The research coordinator will review the weekly appointment schedule of 
referring clinicians. The research coordinator will communicate with the 

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clinicians (i.e., the physicians and advanced practice providers who care for the 
patient in the outpatient setting) via email, through the electronic health record, 
or verbally to notify them that the patient may be eligible for the study and 
inquire about concerns regarding their participation. If the clinicians voice 
objections to the patient enrolling in the study, the research coordinator will 
document the reason and not approach those individuals. If the clinicians have no 
objections, the research coordinator will approach patients either in clinic, by 
telephone, or will send a letter by mail or Patient Gateway.  
 
In this communication, the coordinator will inform the patient that their 
clinicians have indicated they might be eligible and wanted to let them know 
about this study.  
 
20.4. Materials that will be used to recruit subjects. We will use a study 
brochure to provide the initial overview of the study. This will be included 
in an initial contact with participants, whether that is in-person in the clinic, 
via mail, or via patient gateway. The brochure will be accompanied by a 
letter describing the study. 
20.5. Amount and timing of any payments to subjects. Participants will receive 
a $25 gift card when they complete the baseline assessment, a $50 gift card 
after completing the 6-week follow-up survey and semi-structured 
interview, and a $25 gift card for completing the final survey. This leads 
to a total of $100 in gift cards if they complete the full study. 
 
21.0 Local Number of Subjects 
21.1. We expect to enroll at least 4 and up to 20 participants into this study. 
21.2. We do not expect any screen failures in this study. Eligibility can be 
determined prior to enrollment by screening the medical record and 
asking self-report questions.  
22.0 Provisions to Protect the Privacy Interests of Subjects 
Participant confidentiality will be strictly protected. Hard copies of data will be 
maintained in locked files that can only be accessed by study personnel. Data 
forms will be identified using an identification (ID) number only. Access to the 
list cross-tabulating ID numbers with participant names will be kept in a 
password-protected data file following the RISO recommendations. All 
computer systems and programs will be password protected, and all electronic 
communications of study and other confidential information will be encrypted. 
Good computer security practice (shutting down computers after work hours, 
restricting physical access to machines, prohibition of password sharing) will 
be required of all study personnel. Virus protection software is installed on each 
study computer. The virus detection tools are used, maintained, audited and, if 
necessary, updated on all computers and pathways into the system.  Redundant 

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backups allow for quick restoration of data in the unlikely event that a hardware 
failure or security breach occurs. 
The study will be conducted in clinical research laboratories and the IMPACT 
Practice Center at MGH IHP and via virtual visits using confidential 
videoconferencing technology. The IMPACT Practice Center is a pro bono 
therapy clinic with the primary purpose of serving as a vehicle for clinical 
education. All students undergo standardized and rigorous training regarding 
protection of participant confidentiality, and fostering conditions of respect and 
therapeutic rapport. For example, the students are taught to ask preferences for 
how to refer to participants, to conduct evaluation and treatment in private 
rooms or to use screens if practicing sensitive exercises in the gym.  
23.0 Compensation for Research-Related Injury 
23.1. There is no compensation for research-related injury. 
24.0 Economic Burden to Subjects 
• Participants will have free parking when attending in-person study visits at 
MGH IHP. There is a free shuttle from MGH to the parking lot at MGH IHP 
that serves both the IMPACT Practice Center and clinical research 
laboratories. The cost of gas will be offset by the gift cards provided as a 
token of appreciation for study participation. 
25.0 Consent Process 
 
We will follow the procedures delineated in “SOP: Informed Consent Process (CON-
100).” Eligible persons will be provided with an electronic informed consent (eConsent) 
form to review using a browser-based research electronic data capture (REDCap). A 
paper-based consent will remain an option as well. For eligible persons approached in-
person, the eConsent form will be provided via iPad and explained, with ample time given 
to review and ask questions. For eligible persons contacted via letter and telephone, the 
eConsent form will be sent electronically. Our telephone consent procedures mirror our 
in-person procedures. We train our study staff to give the person ample opportunity to 
feel comfortable, express concerns, and ask any questions he or she might have.  
 
Participants who decide to enroll will sign the eConsent form which is then co-signed 
by the consenting study staff. A PDF of the dually-signed consent is sent to the 
participant and an identical copy is retained by the study staff. No study activities are 
initiated until the signed consent form is obtained by study staff. At that time, the 
baseline assessment is scheduled. 
Institutions will register eligible participants in the Clinical Trials Management 
System (CTMS) OnCore as required by DF/HCC SOP REGIST-101. When required 
by REGIST-101, registration must occur prior to the initiation of protocol-specific 
procedures or assessments.  

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Verbal consent will be obtained for all interventionists participating in semi-
structured interviews including permission to audio-record the interview. This 
consent will be obtained using a verbal consent script included in the interventionist 
interview guide. 
 
26.0 Process to Document Consent in Writing 
Consent will be documented in writing as described above, following 
DF/HCC Policy CON-100: Informed Consent Process.  
27.0 Drugs or Devices 
Not applicable. 
 
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