Healthy ME: Advancing Health Equity in Lymphatic Pain and Lymphedema in Black and Hispanic Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Severity and Interference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will only know that they will be assigned to one of the two comparable behavioral and educational programs and they will not know which program is the intervention. Outcome assessors will not know the participants' assigned program throughout the study.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Severity and Interference
时间窗: Pre-intervention (0 week) and Post-intervention (13 week)
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.
Lymphatic Pain
时间窗: Pre-intervention (0 week) and Post-intervention (13 week)
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.
次要结局
- Psychological Distress(Pre-intervention (0 week) and Post-intervention (13 week))
- Lymph Fluid Level(Pre-intervention (0 week) and Post-intervention (13 week))
- Daily Living Function:(Pre-intervention (0 week) and Post-intervention (13 week))
- Patients' Quality of life(Pre-intervention (0 week) and Post-intervention (13 week))
- Self-efficacy for Pain Management(Pre-intervention (0 week) and Post-intervention (13 week))