An interventional study of The-Optimal-Lymph-Flow (TOLF) Program in Breast Cancer, sponsored by University of Missouri, Kansas City. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by University of Missouri, Kansas City · Not applicable, Interventional, and Supportive care
The goal of this two-phase 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. The investigators have 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. The investigators 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.
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. The investigators have 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. The investigators 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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Missouri, Kansas City is the lead sponsor of 47 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
e-Lymph (Control). e-Lymph includes training sessions on the lymphatic system, lymphedema, lymphedema diagnosis and measurement, risk of lymphedema.
Behavioral: The-Optimal-Lymph-Flow (TOLF) Program
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.
Behavioral: The-Optimal-Lymph-Flow (TOLF) Program
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. 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.
Lymphatic Pain
The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part I, a reliable and valid self-report instrument, is used to assess self-reported lymphatic pain, i.e., aching or soreness or tenderness.
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Pain Severity and Interference
Brief Pain Inventory-Short Form (BPI-SF) will be used to measure pain severity and interference. The measure 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.
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Lymph Fluid Level
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 fluid ratio, taking into consideration the ratio between the dominant and non-dominant arms.
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Daily Living Function:
The Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part II is used to measure activity of daily living (ADLs). The 13-item subscale of ADLs in BCLE-SEI Part II is used to assess self-reported difficulty in performing thirteen ADLs.
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
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.
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Patients' Quality of life
Global Health Scale (PROMIS GHS) is used to measure quality of life (QOL) captures self-perception of QOL on a scale from 1 (poor), 2 (fair), 3 (good), 4 (very good) to 5 (excellent). This tool has good reliability (a= 0.80-0.86).
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
Self-efficacy for Pain Management
The 5-item Chronic Pain Self-Efficacy Scale81 with good reliability69-70 is used 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.
Time frame: Pre-intervention (0 week) and Post-intervention (13 week)
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Plan to share: No — We will not share any individual participant data during and after study.
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University of Missouri, Kansas City