Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer
Phase: NA
Conditions: Breast Cancer
Sponsor: University of Missouri, Kansas City

 
 
 
 
 
INTERVENTIONAL 
RESEARCH PROTOCOL  
 
 
 
 
STUDY INFORMATION 
 
§ 
Title of Project: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in 
Black and Hispanic Women with Breast Cancer 
 
§ 
Principal Investigator Name: Mei Rosemary Fu, PhD, RN, FAAN 
 
§ 
Principal Investigator Department:  University of Missouri-Kansas City School of Nursing 
and Health Studies 
 
§ 
Principal Investigator Contact Info:  
Mobile: 973-986-1758 
Email: mei.fu@umkc.edu 
 
§ 
Protocol Version and Date: 
V1-10 12  2023 
 
 
 
 
 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 1 of 16 
 
 
 
ABSTRACT 
 
PURPOSE/SPECIFIC AIMS The purpose of this project is to adapt The-Optimal-Lymph-Flow (TOLF) 
behavioral intervention to be culturally appropriate, and subsequently test the intervention in Black and 
Hispanic patients. Our team has developed and tested behavioral intervention program TOLF that builds 
patients’ self-management skills to promote lymph flow and results in complete pain reduction, reduced 
lymph fluid level, reversed mild lymphedema, and improved quality of life (QOL). Of concern, this promising 
intervention has not been adapted to reduce patient barriers (e.g., relevance, cost, time, travel, competing 
demands) and system barriers (e.g., intervention availability, staffing, therapist) to timely interventions faced 
by Black and Hispanic women. Specific aims are to:  
Aim 1: Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. 
We will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of 
Black and Hispanic women. 
Aim 2:  Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) 
TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine 
primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and 
secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain 
management) of the culturally appropriate behavioral interventions.  
 
RATIONALE/SIGNIFICANCE OF THE STUDY. Lymphatic pain refers to pain, aching or soreness in the 
ipsilateral body or upper limb following breast cancer treatment. More than half of the 3.8 million women 
with breast cancer suffer lymphatic pain which leads to impaired daily living function, psychological distress, 
and compromised QOL. Most importantly, lymphatic pain is significantly associated with lymphedema, a 
chronic and incurable condition caused by an abnormal accumulation of lymph fluid. Black and Hispanic 
women are three times as likely to suffer from lymphedema compared to White women. Timely intervention 
for lymphatic pain can decrease the risk and severity of lymphedema. However, there are persistent barriers 
to timely interventions faced by Black and Hispanic women with breast cancer – a group at high risk for 
developing lymphedema, pain, and other negative breast cancer related outcomes. 
 
THEORETICAL FRAMEWORK. Self-efficacy theory guides the project. Behavioral pain interventions focus 
on training patients on self-management skills to be implemented in their daily lives.  
 
MAIN RESEARCH VARIABLES. Behavioral pain intervention (IV), Outcomes (DVs): lymphatic pain, pain 
severity and interference, lymph fluid level, daily living function, psychological distress, QOL, self-efficacy 
for pain management. 
 
DESIGN. Qualitative and randomized clinical trial (RCT) 
 
SETTING. All participants will be recruited from UMKC University Health and surrounding communities. 
 
SAMPLES. Black and Hispanic women with lymphatic pain  
 
METHODS. Focus groups will be conducted with Black and Hispanic women to gather data that will lead 
to culturally appropriate adaptation of TOLF. Then, a pilot RCT will be used to examine feasibility, 
acceptability, and evidence of future efficacy of this culturally adapted intervention. 
 
IMPLICATIONS FOR PRACTICE. The successful completion of the project will advance health equity in 
pain and lymphedema by making this culturally appropriate, highly accessible, and effective behavioral 
intervention available to Black and Hispanic women.  
 
 
 
 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 2 of 16 
 
 
 
1.0 Research Design 
 
1.1 Purpose/Specific Aims 
Lymphatic pain affects more than half of 3.8 million women treated for breast cancer in the United States.1-
4 Lymphatic pain significantly compromises patients’ daily living function,2 increases psychological distress,5 
and decreases quality of life (QOL).6-7 Lymphatic pain refers to various pain (e.g., aching or soreness) in 
the ipsilateral body or upper limb due to a compromised lymphatic system from breast cancer treatment.2-4 
Lymphatic pain is significantly associated with lymphedema,2-5 a chronic and incurable condition caused by 
an abnormal accumulation of lymph fluid in the ipsilateral body or upper limb.8 Black and Hispanic women 
are three times more as likely to suffer from lymphedema compared to White women following 
breast cancer treatment.9-10 High rates of lymphedema and lymphatic pain in Black and Hispanic women 
are partially due to health inequities as these groups are more likely to be diagnosed with advanced stages 
of cancer leading to more aggressive treatments.11-12 Effective management of lymphatic pain can decrease 
the risk of developing lymphedema and lessen lymphedema severity.13-18 However, there are persistent 
barriers to timely interventions faced by Black and Hispanic patients – a group at high risk for developing 
lymphedema, pain, and other negative cancer related outcomes.9-12 Ethnic disparities in offering 
interventions after pain complaints and financial hardship are identified barriers.2,9-12 The proposed work 
aims to decrease health inequities in lymphatic pain intervention in Black and Hispanic women with breast 
cancer and ultimately decrease the development of and lessen the severity of lymphedema, a chronic and 
debilitating illness for these women. 
We have developed and tested in largely White patients a non-pharmacological, behavioral 
intervention, The-Optimal-Lymph-Flow (TOLF) that builds patients’ self-management skills to promote 
lymph flow and results in complete pain reduction, reduced lymph fluid level, reversed mild lymphedema, 
and improved QOL.13-21 Of concern, this promising intervention has not been adapted to reduce patient 
barriers (e.g., relevance, cost, time, travel, competing demands) and system barriers (e.g., intervention 
availability, staffing, therapist) to timely interventions faced by Black and Hispanic women. The purpose of 
this two-phase project is to adapt The-Optimal-Lymph-Flow (TOLF) a non-pharmacological, behavioral 
intervention to be culturally appropriate, and subsequently test the intervention in Black and Hispanic 
patients. We will recruit study participants from UMKC University Health. Women of minority are more likely 
to have comorbid health problems (e.g., obesity/high body mass index [BMI]) and financial hardship;2,11-
12;25-28 which are risk factors for lymphatic pain and lymphedema.2-3;30-32  Based on prior research and our 
preliminary studies,3-18  our central hypothesis is that lymphatic pain increases the risk of lymphedema 
and behavioral intervention can reduce pain and lymph fluid level to prevent lymphedema. Our group is 
uniquely qualified to lead this project due to our expertise in lymphedema, lymphatic pain, health disparity, 
breast cancer, pain and cancer-related symptoms, and the clinical volume of Black and Hispanic patients 
with breast cancer at our center. Guided by self-efficacy theory,33-34 the specific aims of this two-phase 
project are to:  
 
Aim 1:  Engage Black and Hispanic women (N=24) in adapting TOLF to be highly culturally appropriate. 
We will conduct focus groups to refine TOLF focusing on barriers faced by and preferences of 
Black and Hispanic women. 
Aim 2:  Conduct a pilot randomized controlled trial (RCT) (N=60) equally allocating women to either 1) 
TOLF or 2) lymphedema education (e-Lymph) to examine feasibility, acceptability, and examine 
primary outcomes (lymphatic pain, pain severity and interference, and lymph fluid level) and 
secondary outcomes (daily living function, psychological distress, QOL, self-efficacy for pain 
management) of the culturally appropriate behavioral interventions.  
Impact. Our project has the potential to have a major impact on reducing cancer-related disparities 
(lymphedema, pain, QOL) among Black and Hispanic women. The project will also build clinical capacity 
to provide quality care for lymphatic pain and lymphedema prevention for women living in environmental 
justice communities. By focusing ethnic disparities in offering behavioral interventions to Black and Hispanic 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 3 of 16 
 
 
 
women, adapting and testing interventions for culturally sensitive care, this project addresses ONS 
Research Agenda Priority of Cancer Health Disparities and Promote Equity in Oncology Healthcare Access.  
 
1.2 Research Significance 
Lymphatic pain is a cardinal sign for an early stage of lymphedema.35-37 Patients who report lymphatic pain 
are nearly twice as likely to develop lymphedema.4 Without timely intervention in this early stage, 
lymphedema can progress into a chronic condition that no surgical or medical interventions can cure.8 In 
addition, lymphatic pain and lymphedema significantly impact patients’ daily living function,2,38-39 
psychological distress,5 and QOL.40-41 The burden from lymphatic pain and lymphedema and can be even 
higher for Black and Hispanic women. Studies show that women of racial minority background experience 
delays in breast cancer treatment and/or inadequate treatment.10-12;42-45 Later stage diagnosis and delayed 
treatment lead to high risk of lymphedema and pain due to the needs to have more aggressive surgical 
treatment, more lymph nodes removed, and radiation.9-12 Further, women of minority are more likely to have 
comorbid health problems (e.g., obesity), 2,11-12;25-28 the risk factor for lymphatic pain and lymphedema.3;31-
34  Women with financial hardship are 4.64 times more likely to report lymphatic pain.2 Our recently 
published study detailed that patients with lymphatic pain reported impairments in 45% of ADLs and had a 
significantly increased risk of having difficulty in performing all the 13 ADLs (i.e., cooking, using a knife, 
writing/typing, cleaning, vacuuming, laundry, carrying objects, yard work, dressing self, bathing self, driving, 
making bed, and taking care of children).2 Patients’ psychological distress was further compounded when 
they felt that clinicians did nothing but “pity me.”5 Disparities among women with breast cancer in 
environmental justice communities are maintained by a lack of cost-effective, accessible, and appropriately 
adapted supportive care opportunities found at more resourced medical centers.43-44 This results in a large 
symptom burden (i.e., lymphatic pain,) for patients, providers, and healthcare systems. 
 
1.3. Theoretical Framework 
Self-efficacy theory guides the proposed project.33-34 Behavioral interventions for managing lymphatic pain 
and lymphedema prevention focus on 
building patients’ self-management skills 
to be implemented in their daily lives 
outside 
clinical 
settings 
without 
professionally 
administered 
therapy 
(e.g., by therapists or nurses).14-17 To 
achieve the therapeutic effects, patients 
have to execute self-management skills 
outside of clinical settings. Self-efficacy is 
defined as a person’s belief in his/her 
ability to perform specific skills to reduce 
lymphatic 
pain 
and 
to 
prevent 
lymphedema. (See Adjacent Figure).  
 
1.4. Review of Literature 
State-of-the-Art for Lymphatic Pain and Lymphedema Prevention. Behavioral strategies are commonly 
used for pain control in cancer patients.50-53 Pharmacologic interventions, such as NSAIDS, opioids, 
antiepileptics, ketamine and lidocaine, have very limited effects on pain;8,46-49 Very limited RCTs were 
designed to build patients’ self-management skills to manage lymphatic pain, a major predictor for 
lymphedema, impaired daily living  function, psychological distress, and poor QOL.2-5 Majority of RCTs were 
devoted to lymphedema treatment administered by professional therapists, such as Complete 
Decongestive Therapy (CDT), compression garments and bandaging, pneumatic pumps, or supervised 
physical therapy.50-52 The cost and time to attend therapist-administered treatments, the potential harm by 
the poor fit of compression sleeve, and patients’ unwillingness to wear and cost for compression sleeve 
remain wide-spread challenges for patients. These challenges can be even more impactful for Black and 
Hispanic patients who face personal barriers (e.g., time, travel, competing demands, cost) and system 
barriers (e.g., treatment availability, staffing, therapist). 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 4 of 16 
 
 
 
Behavioral Interventions Are Efficacious in Treating Lymphatic Pain. Lymphatic pain is associated 
with increased lymph fluid accumulation,2-4 and inflammatory responses.39-41 Limited research tested 
integrative behavioral interventions based on physiological (lymph fluid accumulation and inflammation) 
and cognitive principles (low self-efficacy). We have developed and extensively tested a non-
pharmacological, behavioral The-Optimal-Lymph-Flow (TOLF) intervention that includes strategies to 
promote lymph flow: therapeutic lymphatic exercises, healthy diet (i.e., nutrition-balanced, portion-
appropriate diet, adequate hydration), and proper sleep.13-21 The core TOLF intervention is 8-minute TOLF 
lymphatic exercises to promote lymph flow (i.e., muscle-tightening deep breathing, muscle-tightening 
pumping, and limb mobility exercises).13 TOLF includes a website that provides patients with TOLF 
intervention materials, information, and daily assessments used to personalize sessions.13-21 One dose of 
TOLF lymphatic exercises can produce immediate significant effects on reductions in pain, swelling, and 
reduction in lymph fluid levels.13 Our recent publish RCT demonstrated that 50% of patients who received 
TOLF intervention achieved a complete pain reduction (50% vs 22%; OR=3.56, CI = [1.39, 9.76], p=0.005) 
compared to control of 22%.14 Given TOLF is  efficacious, focusing on self-management skills, having 
immediate therapeutic effects, and welcomed by patients (only 6% attrition), TOLF may provide particular 
benefits for Black and Hispanic patients who face personal challenges of time, travel, competing demands, 
cost for therapist-administered treatment. In addition, technologically-driven delivery model makes it easy 
for community-level implementation to address system barriers of intervention availability, staffing, 
therapist.  
 
1.5. Innovation 
This project is innovative for multiple reasons. 1) This will be the first study to address ethnic disparities and 
system barriers (e.g., intervention availability, staffing, therapist) in offering behavioral interventions to Black 
and Hispanic women with lymphatic pain to prevent lymphedema by adapting efficacious, non-
pharmacological, behavioral interventions to be culturally appropriate, and subsequently test the 
interventions in Black and Hispanic patients. 2) The project is innovative in disrupting place-based health 
disparity and social determinants of health on lymphatic pain and lymphedema prevention. There is an 
increased urgency for completing the proposed project in the population of interest rather than hoping to 
recruit “enough” Black and Hispanic participants to examine disparities. Our ongoing community 
engagement, our geographic location, and our current and prior successful experiences25-26 with patients 
in environmental justice communities enable us  to engage Black and Hispanic patients in these hard-to-
reach settings. 3) The use of technologically-driven intervention delivery not only enhances the fidelity and 
transparency of the interventions but also the reproducibility of the interventions, which may enhance the 
generalizability and dissemination of the interventions. 4) This project is innovative in addressing major 
personal barriers (e.g., cost, time, travel, competing demands) faced by Black and Hispanic patients. For 
example, the adaption of the daily 8-minute TOLF lymphatic exercises, which is effective even with one 
dose13 and easy for patients to implement it;13-18 in turn, it addresses barriers of limited time and competing 
demands faced by Black and Hispanic women. 5) Because previous research found that traditional 
measures of ADLs (i.e. toileting, ambulation, continence, and feeding) are less relevant to women with 
breast cancer,2,5,38-41 the breast cancer specific measures of ADLs is another innovation.2,38 6). The 
proposed intervention is cost-effective and sustainable (e.g., by intervening in the health system and 
reducing the reliance on pain medication and medical intervention).  Thus, our project provides a unique 
opportunity to provide empirical evidence and generate knowledge to advance health equity in lymphatic 
pain and lymphedema prevention. 
 
1.6. Preliminary Work and Research Team 
Dr. Mei Rosemary Fu (The Dorothy and Dale Thompson Missouri Endowed Professor in Nursing and 
Associate Dean for Research) is a well-established nurse scientist who is well-positioned to lead the project 
as the PI. Dr. Fu is one of very few researchers who has had funded work on lymphedema, pain and 
symptoms related to lymph fluid accumulation, and developing non-pharmacological behavioral 
interventions to prevent lymphedema and pain following breast cancer treatment (F31 NR07851, 
1R21NR012288-01A1, P60 MD000538-03 [Pilot PI],  1R01CA214085-01 [Multiple PI], Oncology Nursing 
Foundation, 13371953 The-Optimal Lymph-Flow Pfizer Independent Grants for Learning & Change, Avon 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 5 of 16 
 
 
 
Breast Cancer Research Grant 02-2008-077). She has led multiple projects on lymphedema and pain and 
from which this proposed study is built upon.2-5,13-21,35-36;38 Dr. Fu also has extensive and published 
experience working with minority patients and residents in environmental justice communities;25-26,53-54 such 
experience will ensure the success of the project. Dr. Fu has established a strong collaboration within the 
University Missouri communities and nursing team with whom Dr. Fu has worked closely on the proposed 
project (co-investigators: Drs. Cynthia L. Russell Lippincott, Sue Lasiter, Elizabth Ann Anderson, and 
Steven Chesnut). We have a strong research team with rich research experience in developing and testing 
behavioral interventions in women with breast cancer and health disparities.  
 
1.7. Research Design and Methods 
Design. This two-phase project uses qualitative 
(i.e., focus group) and pilot randomized clinical trial 
(RCT) design to adapt TOLF to be culturally 
appropriate, and subsequently test the intervention 
in Black and Hispanic patients. (See Adjacent 
Figure for study design.)  
Sample. The participants are Black and Hispanic 
women (over age 18) with lymphatic pain following 
breast cancer treatment. These women will be 
recruited for the Phase I  focus groups (N=24), and 
the Phase II  RCT (N=60). Participants will include 
women who 1) have received surgical treatment for breast cancer at least 3 months prior to the study 
enrollment, 2) report persistent or intermittent pain/aching/soreness in the ipsilateral body or upper limb; 3) 
self-identify as either Black or Hispanic; and 4) are able to understand the study protocols presented in 
English. Exclusion criteria include: 1) presence of a serious psychiatric condition (e.g., schizophrenia, 
suicidal intent) indicated by medical chart, treating oncologist or other staff, or study staff interactions that 
would contraindicate safe study participation; 2) known metastatic disease (Stage IV), recurrence of cancer, 
or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions; 3) were 
diagnosed or treated for lymphedema.  
 
Setting. All participants in the proposed work will be recruited from UMKC (University of Missouri-Kansas 
City) Health System and Kansas City Metropolitan eastside communities, which is recognized as the fifth 
most economically and racially segregated city in the U.S. Black and Latino individuals in Kansas City, 
Missouri (KCMO) die up to 18 years earlier than White individuals. Majority of breast cancer patients are 
Black and Hispanic and rely on Medicaid and Medicare for health insurance. Drs. Lippincott, Lasiter have 
strong collaboration with University Health and will be responsible for the recruitment.  
 
Recruitment. Our team consists of experienced clinical trials investigators with extensive histories of 
successful recruitment. We will use electronic medical records (EMR), tumor registry information, and clinic 
staff to identify potential trial participants. The clinical research coordinator will send an email to the treating 
oncologist to alert them of potential participants. Participating oncologists will alert the study team if there 
is a known psychotic disorder, suicidal intent, or other conditions that would contraindicate safe study. 
Potential participants will be mailed a letter or an email or a phone call from their provider or the research 
study team with study information. The communication will let the patient know that a member of the study 
team will call them to follow-up; an opt-out phone number will also be provided. Following recruitment 
communication, study staff will contact potential participants to assess interest in the study and to conduct 
pre-screening. If patients meet eligibility criteria, they will be invited to schedule informed consent in-person 
or via telephone. All participants will continue to receive routine standard medical care from their medical 
team. The study team will closely track participant recruitment; additional clinics will be quickly implemented 
if recruitment has not been met at 90% in any 3-month period. 
 
Phase I Focus Groups. The TOLF intervention will be adapted to be culturally-appropriate using input from 
Black and Hispanic women with lymphatic pain (N=24; 2 groups: Black [n=12] and Hispanic [n=12]). To our 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 6 of 16 
 
 
 
knowledge, this is the first study to systematically adapt efficacious behavioral interventions for Black and 
Hispanic women with lymphatic pain. To adapt the interventions, we will use qualitative data gathered 
during focus groups held separately with Black and Hispanic patients. Semi-structured interview guides will 
be used to facilitate focus groups; we have drafted a focus group discussion guide. The group leaders (Drs. 
Lippincott, Anderson, and Lasiter, co-investigators) will guide the discussion. The interview guides will be 
reiterated following each group to attend to themes of previous groups. The aim of the focus groups is to 
better understand the needs and preferences of the Black and Hispanic women with lymphatic pain. Each 
Black and Hispanic woman will participate in two sessions of focus group. In Session I, Black and Hispanic 
women will be systematically presented with the content of TOLF and be asked to provide their opinions 
on the content, the current patient handouts, and how to modify the handouts, the intervention format (e.g., 
in-person, web-based, telehealth conferencing, timing of interventions, length of the intervention). 
Participants will be asked to practice TOLF self-management skills for a week before Session II. Session II 
will focus on barriers in implementing TOLF self-management skill to further refine the interventions. All 
focus groups will be 60 minutes long and audio recorded. Our team has extensive experience conducting 
qualitative interviews and focus groups, as well as a using focus groups to inform intervention adaptation 
and development.5,25-26,53,58 
 
Intervention/Independent 
Variables. 
Phase 
II 
RCT 
Randomization 
and 
Conditions. In Phase II RCT, a total of 60 
participants will be recruited consisting of 
30 
Black 
and 
30 
Hispanic 
patient 
participants, 
respectively. 
Following 
baseline assessment, 30 Black and 30 
Hispanic 
patient 
participants 
will 
be 
randomly assigned with equal allocation to 
one 
of 
two 
conditions: 
1) 
TOLF 
(Intervention), or 2) e-Lymph (Control). e-
Lymph includes training sessions on the 
lymphatic 
system, 
lymphedema, 
lymphedema diagnosis and measurement, 
risk of lymphedema. The major goals of 
skill training sessions for TOLF and e-
Lymph 
are 
described 
in 
Table 
1. 
Randomization will be blocked by ethnicity 
to ensure reasonable balance in each 
treatment condition. The data manager on 
this study who is not involved with 
recruitment will randomly draw a number of 
1, or 2 to be given the participant’s study 
number (not name) to randomize the 
participant. Our research evaluator will not 
be involved in recruitment or have other contact with participants; she/he will be blinded to participant 
randomization and conduct all study procedures where blinding is indicated (e.g., assessments). All efforts 
will be made for study staff and oncologists to be blinded to participant condition.  
 
The-Optimal-Lymph-Flow (TOLF). TOLF includes training sessions on the lymphatic system, 
lymphedema, lymphedema diagnosis and measurement, risk of lymphedema, healthy diet, sleep hygiene, 
and daily lymphatic exercises. It has 8 avatar videos with step-by-step instructions for TOLF lymphatic 
exercises to promote lymph flow. In Phase I, Aim 1 will adapt the intervention to be culturally sensitive, 
some changes are expected in the final intervention protocol. It is expected that participants will complete 
initial in-person or telehealth virtual 40-minute session, and 3 virtual telehealth sessions with each session 
for 20-minute over the course of 8 weeks. In initial in-person session, the participant will be trained to 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 7 of 16 
 
 
 
practice lymphatic exercises using Kinect-Enhanced TOLF training system, which is a smart AI (artificial 
intelligent) training system to ensure patients practice lymphatic exercise correctly.13 For the telehealth 
sessions,  the participant and interventionist will complete a session once the telehealth session has been 
connected. For 8-week study duration, participants in TOLF will be asked to practice lymphatic exercises 
twice a day. They will also be directed to use the strategies presented in the program and review the 
strategies periodically on the website. A workbook will be provided to record practice of the daily lymphatic 
exercises and large muscle exercises. The sessions will be scheduled bi-weekly with some flexibility (8 
weeks to complete sessions) provided for scheduling conflicts (e.g., sickness, holidays). The content of the 
TOLF protocol was carefully designed choosing skills shown to be efficacious in reducing lymphatic pain 
and lymph fluid level.13-16  
 
Intervention Training Protocol. Intervention training for TOLF is designed to provide training that will 
result in a high level of intervention fidelity. Interventionists on this trial will be licensed nurses or nurse 
practitioners; this model increases patient access to interventions as clinical sites often do not have staff to 
conduct such interventions. Training will be organized into four sessions expected to take a total of four 
weeks to complete. Study interventionists will undergo training and be certified through conducting practice 
role-play sessions that are recorded and rated by Drs. Fu. Treatment Adherence and Credibility, Therapist 
Competence. Treatment adherence refers to the extent to which interventions are delivered as prescribed.59 
TOLF protocol adherence and competence ratings will be made by Drs. Fu, which is defined > 90% of the 
maximum score; and 10% of the trial sessions will be randomly evaluated. 
Referral Plan. Patient participants who report no pain reduction at the end of the study will be referred to 
their oncologists for further medical intervention through an existing physician-nurse referral system. 
 
1.8. Variables and Instruments 
Feasibility. Feasibility will be assessed by examining (a) study accrual of Black and Hispanic breast cancer 
patients (N=60 over 9 months), (b) protocol adherence (>80% adherence to the protocol [defined in this 
study as the degree to which participants are willing and able to complete the intervention exposure], e.g., 
TOLF, e-Lymph, and (c) participant retention (>80% data collected at the study appointment, including pre-
randomization (A1-Week 0) and post-assessments (A2- Week 9 and A3- Week 13). Acceptability. 
Acceptability will be assessed post-intervention using the validated scale of patient satisfaction and 
acceptability and exit interview.60  
 
Primary and Secondary Outcomes. Lymphatic Pain: The Breast Cancer and Lymphedema Symptom 
Experience Index (BCLE-SEI) Part I, a reliable and valid self-report instrument,54,61-63 is used to assess self-
reported lymphatic pain.2-3,13,64 The items are rated on a Likert scale from 0 (no lymphatic pain/swelling) to 
4 (greatest severity of lymphatic pain/swelling). Pain Severity and Interference: are measured using the 
Brief Pain Inventory-Short Form (BPI-SF) with demonstrated reliability and validity.65 The BPI-SF consists 
of four items assessing pain severity (worst, least, average, and current pain) and seven items assessing 
pain interference in the past week. Lymph Fluid Level by Bioimpedance: The Imp XCA® (Impedimed, 
Brisbane, Australia), a bioelectrical impedance analysis (BIA) device is used to assess lymph fluid level. 
The device measures the resistance of the extracellular fluid (i.e. the impedance) in terms of the L-Dex 
ratio, taking into consideration the ratio between the dominant and non-dominant arms.66-67 Daily Living 
Function: Daily living function is operationalized as Activities of Daily Living (ADLs) that reflect the real-
world daily living of breast cancer patients. The 13-item subscale of ADLs in BCLE-SEI Part II is used to 
assess self-reported difficulty in performing thirteen ADLs.2,38 Cronbach’s alpha for the ADLs subscale is 
0.94.2,38  Psychological Distress. The 12-item subscale of psychological/emotional distress subscale from 
the BCLE-SEI Part II is used to assess the distress of being frustrated, sad, guilt/self-blame, worried, 
irritable, fearful, angry, lonely, helpless, hopeless, anxious, and depressed. Cronbach’s alpha for the 
psychological/emotional distress subscale was 0.91.62,64 Quality of Life. The 10-item V1.2 Patient Reported 
Outcome Measure Information System Global Health Scale (PROMIS GHS), (a= 0.80-0.86)68 that captures 
self-perception of QOL on a scale from 1 (poor), 2 (fair), 3 (good), 4 (very good) to 5 (excellent). Self-
efficacy for Pain Management. The 5-item Chronic Pain Self-Efficacy Scale81 with good reliability69-70 is used 

 
 
 
Mei Rosemary Fu 
Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
V1:10 12 2023 
Page 8 of 16 
 
 
 
to assess patients’ certainty about their degree of pain control, pain during daily activities, controlling pain 
during sleep, and making pain reductions without extra medication.  
 
Potential Covariate Variables. Socioeconomic Determinants of Health. Items to screen for social needs 
and financial strains in The Accountable Health Communities (AHC) model71-76 are used to assess 
socioeconomic determinants: (1) 2-item for living situation, (2) 2-item for food, (3) 1-item for transportation, 
(4) 1-item for utilities, (5) 4-item for safety, and (6) 1-item for financial strain. Medical and Demographic 
Information. Demographic data includes age, race, marital status, education, income. Patients will provide 
information on ethnicity, marital status, and education. Participants’ electronic medical record will provide 
initial and/or recurrent diagnosis date, disease stage, cancer treatments (i.e., chemotherapy, radiation, 
surgery history/type), medical comorbidities, height and weight, and use of antidepressant, anxiolytics, and 
pain medications. 
 
1.9.a. Data Collection Schedule and Procedures.  
Data Collection. Participants in Phase II/Aim 2 RCT will have three in-person research visits to complete 
study assessment measures pre-randomization (A1-Week 0), post-intervention assessment measure (A2-
Week 9 and A3-Week 13). Data collection during each in-person visit will take approximately 30 minutes. 
Data Recording. All participants will be assigned a unique study identification number to ensure 
confidentiality. Demographic and cancer treatment related data, will be recorded directly into the computer 
database. Bioimpedance data are recorded directly into the computer database. Field notes at each data 
collection point will be digitally-recorded and transcribed for data coding and summary. Data Storage. Data 
will be stored in locked files accessible only to the research team. Electronic data will be stored in a 
password protected computer accessible only to the PI, Co-Investigators, and the research team members.  
 
1.9.b. Data Analysis and Interpretations  
Qualitative Data Analysis (Phase I/Aim 1). Qualitative data obtained from focus groups will be transcribed 
verbatim. We will use NVivo software to manage data and assist in data analysis. We will use a modified 
iterative descriptive data analysis method 5,25-26,53,58 to ensure the credibility of data analysis. This iterative 
process will be used to examine data, compare codes, challenge interpretations, and develop themes 
inductively. Essential themes and descriptive summary will be produced and used to inform the intervention. 
 
Statistical Analysis for Phase II/Aim 2. Sixty patients (N=60) will be randomized into two equal sized 
groups with 1:1 ratio, either to TOLF or e-Lymph group. Feasibility will be assessed by examining (a) study 
accrual of breast cancer patients (N=60 over 9 months), (b) protocol adherence (>80% adherence to the 
protocol [defined in this study as the degree to which participants are willing and able to complete the 
intervention exposure], e.g., TOLF or e-Lymph), and (c) participant retention (>80% data collected at the 
study appointments). Acceptability will be assessed post-intervention using the validated scale of patient 
satisfaction and acceptability and exit interview.77 Evidence of Promising Outcomes. Assuming a minimum 
protocol adherence of 80%, there will be at least 48 participants who will rate whether treatment is 
acceptable. Assuming acceptability is 50% which has the most conservative precision interval, the 
acceptability will be estimated within 8%.  
 
Primary Endpoint. The primary endpoint is the complete reduction of lymphatic pain and reduced pain 
severity and interference reported by participants, and reduced lymph fluid level at week 13 post 
intervention.  
 
Statistical Analysis for Outcomes. We hypothesize that participants who receive the TOLF will have 
better primary and secondary outcomes than participants who receive the control e-Lymph over time. Since 
outcomes will be measured at week 0 (baseline), 9 weeks and 13 weeks post intervention, generalized 
estimating equation (GEE) model will be used for analyzing each outcome to accommodate the correlation 
among the repeated measurements within a same subject.78 Different working correlation matrices will be 
tested to select the most propriate one for the GEE models. Identity link and logit link will be used for 
continuous outcomes  (lymphatic pain severity, pain severity and interference, lymph fluid level, daily living 

 
 
 
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Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
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function, psychological distress, QOL, and self-efficacy for pain management) and binary outcome 
(complete pain reduction), respectively. The predictors include two indicators of intervention and control  
groups respectively. Covariates found to be significantly different between the groups at baseline, will be 
included in the GEE model.79 If the primary outcomes of the intervention group are significant at alpha 0.05, 
we will conclude the intervention works better than the control. Proper methods will be used to address any 
missing data to maximize the statistical power of our analyses and reduces the likelihood of systematic bias 
in estimates.  
 
2.0 PROTECTION OF HUMAN SUBJECTS 
 
We will obtain human subject approval and necessary HIPAA waivers from the Internal Review Board (IRB). 
We will obtain written informed consent from all participants. We will fully disclose all risks and benefits to 
the participants and give them ample opportunity to decline participation. Documentation is provided here 
and for each of the Human Subjects’ points.  
 
2.1. Human Subjects Involvement and Characteristics 
This two-phase project uses qualitative (i.e., focus group) and pilot randomized clinical trial (RCT) design 
to adapt behavioral interventions (The-Optimal-Lymph-Flow [TOLF]) to be culturally appropriate, and 
subsequently test the interventions in Black and Hispanic patients. Thus, participants in this work are Black 
and Hispanic women (over age 18) with lymphatic pain following breast cancer treatment. These women 
will be recruited for the Phase I  focus groups (N=24), and the Phase II  RCT (N=60).  
 
2.2. Recruitment and Informed Consent 
All recruitment procedures will comply with HIPAA guidelines. The recruitment procedure will be as follows. 
For potential participants from University Health, potential participants will be identified through electronic 
medical record review, or their medical team or potential participants will call the researchers if they see 
the study flyer and are interested in the study. Once a potential participant has been identified, their primary 
oncologists will be contacted for permission to attempt to recruit the participant for this study if the potential 
participants are from University Health. If the oncologist agrees, potential participants will be told about the 
study by a member of the medical staff and asked if they would be willing to talk with a member of the study 
team. Potential participants will also be sent an email or a letter through postal mail letting them know that 
someone will call about the study or meet them at their clinic visit or give them a number to call to completely 
opt out of any further study activities. If interested in participating in the study, an appointment will be 
scheduled at which time the study will be explained in detail and signed consent will be obtained.  
For potential participants from communities, potential participants will call or email the researchers to 
express their interest in the study and the researchers will contact the potential participants to confirm 
their interest in the study and eligibility.  
Once a potential subject confirmed their interest in the study either from University Health or communities, 
a member of the study team will meet the potential participants either in person or virtual as they prefer, 
the researcher will describe the study in detail, provide the patient with consent forms either in paper or 
electric form, and offer to answer any questions about the study. Potential participants will then be given 
sufficient time to read over the consent form, at which time the PI or a member of the study team will ask 
if they have any further questions. The final component of the consent process will involve reviewing a 
brief checklist that outlines the major aspects of the study to confirm that the subject fully understands the 
protocol.  
Research subjects will also be asked to carefully review the section in the consent form, entitled, 
PERMISSION (AUTHORIZATION) TO USE OR SHARE HEALTH INFORMATION THAT IDENTIFIES 

 
 
 
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Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
Cancer 
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YOU FOR A RESEARCH STUDY, at the time they sign the general study consent form. This document, 
written to ensure compliance with HIPAA Privacy Rule guidelines, provides detailed information about 
what information is being collected, the participant’s privacy rights, and to whom the information may be 
disclosed. The participant will then sign the consent either in-person or through the electronic signature 
and be given a signed copy of the consent forms for their records. 
Each participant in the focus group will be assigned a pseudonym (i.e., a fake name) to safeguard her 
identity and protect privacy. The focus group session will be audio recorded using a digital recorder. The 
audio-recording(s) will be used to transcribe only using pseudonym and ensure the accuracy of each 
woman’s experience from the focus group discussions. Only the research team will have access to the 
audio recording. For focus group conducted in zoom and in person, pseudonyms will be used throughout 
the whole session. 
For pilot RCT, each participant will be assigned a unique study ID (e.g., TOLF_001 to TOLF_060). 
2.3. Protection Against Risk.  
The primary risks of this study are those associated with confidentiality. There is some risk attendant to 
confidentiality of self-report data. Two password protected databases will be used for this study to ensure 
confidentiality. First, a tracking database will be used for recruitment and follow-up. This data will house 
information related to tracking the participants in the study, such as phone numbers and addresses. No 
medically sensitive or outcome data will be stored in this database. This database will also track 
nonparticipants (i.e., those who have declined participation) only to the barest minimum to ensure that they 
are not contacted again about participation. At the end of the study, all identifiable data of non-participants 
such as their names will be deleted. Tracking data on participants will be retained for the usual required 
period. Second, all study data will be stored in a separate password protected database without any 
personal identifiers. Data in this database will be derived from patients’ direct input into the electronic patient 
reported outcomes system which is an online survey system; data entered into this system is stored on a 
secure server housed behind the UMKC firewall. Only a unique study identification number will link the 
electronic data to the study data file. The tracking data and study data will be stored in a file on a secure 
study computer which can only be accessed by necessary members of the research team. Access to the 
computer requires a password protected. 
 
2.4. WOMEN AND MINORITY INCLUSION IN CLINICAL RESEARCH 
 
Inclusion of Women: Sex as a Variable: Breast cancer occurs predominantly in women (13%; 1-in-8 
women lifetime risk) than men (0.1%).1 Each year, an estimated 268,600 women in the US are diagnosed 
with invasive breast cancer but only about 2,670 men.1  As such, 100% of patient participants will be women.  
 
Inclusion of Minorities: This proposed project aims to develop culturally appropriate, highly accessible, and 
effective behavioral interventions to reduce lymphatic pain and prevent lymphedema that will address 
barriers related to social determinants of health faced by Black and Hispanic women. Thus, the project 
includes only Black and Hispanic women with lymphatic pain following breast cancer treatment.  
 
Inclusion of Individuals Across the Lifespan: Breast cancer does not occur in prepubescent children.1 
Breast cancer rarely occurs in individuals under age 18, individual under age 18 who are diagnosed with 
invasive breast cancer will be excluded. The project includes only adult women over age 18 with pain and 
swelling following breast cancer treatment.  
 
 
3.0 References 
 

 
 
 
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Project Title: Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women with Breast 
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Cancer 
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Mei Rosemary Fu 
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Cancer 
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