A Feasibility Trial of ScarWork on Post-breast Surgery Pain Syndrome (PBSPS) in Early Stage Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- BREAST-Q Breast Conserving Therapy Module V2.0
研究概览
简要总结
Breast cancer is the most common cancer in women in the United Kingdom (UK). Most women are treated with a combination of surgery and radiotherapy. While these treatments are effective, they can cause ongoing breast pain for some, which can last months or even years. This long-term pain can have a major impact on quality of life, yet it is often overlooked and not well managed in routine care.
One in three women may still experience breast pain three years after treatment. The pain can come from scarring, tissue damage, or nerve changes caused by surgery and radiotherapy. Treatments for this pain are limited. Many patients are advised the pain will subside on its own or are given basic painkillers, which sometimes have limited impact.
ScarWork is a light-touch manual therapy, developed in the United States and aims to improve the way scars feel and look, reduce pain and tightness, and support healing. Although it has been available in the United Kingdom since 2014, there is very little research into whether ScarWork helps people who experience pain after breast cancer treatment.
This small study is a first step to see whether ScarWork could be a useful treatment for people who have experience breast pain after surgery and/or radiotherapy. The researchers want to know:
- Can this therapy be delivered in an NHS setting?
- Do people find it helpful?
- Is it worth doing a larger trial in the future?
Participants will be randomly placed in one of two groups: one group will continue with usual care, and the other will receive up to five sessions of ScarWork in addition to usual care. Everyone in the study will be asked to complete short questionnaires about their pain and other symptoms, before and after treatment, and again one month later. Participants will also be invited to talk about their experiences in a short phone or online interview.
This research will help show whether ScarWork might be a useful option for people dealing with breast pain after treatment. It will also help researchers design a larger trial in the future to test ScarWork more fully.
详细描述
Background Breast cancer is the most common cancer among women in the United Kingdom (UK). Each year, around 57,000 women are diagnosed. Many are treated with a combination of breast-conserving surgery (also known as a lumpectomy) and radiotherapy. These treatments are highly effective but can result in significant trauma to the breast tissue and skin, leading to long-term pain for some individuals.
Although short-term pain after surgery and radiotherapy is expected, some people go on to experience persistent and sometimes worsening pain long after the area has healed. This condition, often referred to as Post-Breast Surgery Pain Syndrome (PBSPS), can interfere with day-to-day life, emotional wellbeing, and recovery. Research suggests that as many as 40% of women still experience breast pain up to three years after treatment.
Despite this, there are currently few treatment options specifically targeting PBSPS. Most patients are offered basic pain relief or reassured that the pain will eventually fade. Surveys show that while most breast cancer specialists recognize this pain as a common issue, less than half routinely offer specific treatment for it.
ScarWork is a manual light touch therapy technique developed by therapist Sharon Wheeler in the United States. It involves gentle, targeted touch of scar tissue with the goal of improving tissue mobility, reducing pain and discomfort, and supporting healing. ScarWork has been used in the United Kingdom since 2014, but very little scientific research has been done to evaluate how effective it is, particularly for people experiencing post-surgery breast pain.
A previous evaluation found that cancer survivors who received ScarWork reported less pain, improved scar appearance and sensation, and a general reduction in symptoms. However, these findings were based on an early-stage service evaluation rather than a formal clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18
- •Early breast cancer patients who have had breast surgery with curative intent
- •Radiotherapy completed ≥ 6 months previously
- •In remission with no sign of active local disease
- •Registering a score of ≥3 on perceived pain intensity or pain burden on a 10-point numerical rating scale (NRS)
- •English speaking and able to communicate reasonably well
- •Able to give informed consent
- •Willing to attend for regular treatment at RLHIM
排除标准
- •History of post-breast surgery wound complications
- •History of breast surgery unrelated to breast cancer treatment
- •History of previous ScarWork therapy
- •Diagnosis of lymphoedema
- •Severe co-morbidities or cognitive disability
- •Receiving physiotherapy for post-breast surgery pain syndrome at the time of trial
研究组 & 干预措施
ScarWork plus standard care
Participant received up to 5 ScarWork sessions alongside usual standard of care
干预措施: ScarWork therapy (Other)
Standard care
Participants continue with their usual standard of care and symptom management without additional intervention.
结局指标
主要结局
BREAST-Q Breast Conserving Therapy Module V2.0
时间窗: Baseline (Week 0, before first session), Week 12 (at final ScarWork session; control group same time point), Week 16 (4 weeks post-final session; control group same time point).
A validated patient-reported outcome measure designed to evaluate outcomes among women undergoing breast conserving therapy, with the two overarching domains of 1) health-related quality of life and 2) patient satisfaction. Scales can be used selectively as appropriate to the research. For this study, we will measure: 1. Quality of life domains using: * Psychosocial Well-being scale comprises 10 items that ask about body image and a woman's confidence in social settings, as well as emotional health and self esteem. * Sexual Well-being scale comprises 6 items that ask about feelings of sexual attractiveness and confidence relating to breasts. * Physical Well-being * Chest scale comprises 9 items measuring problems in the breast area (tightness, pulling, tenderness, pain), activity limitations and sleep problems due to discomfort. * Adverse Effects of Radiation scale 2. Satisfaction with Breasts
次要结局
未报告次要终点
研究者
John Hughes
Associate Professor/ Head of Research
University College London Hospitals