The Use of 3D Surface Imaging to Simulate Outcome After Breast Conserving Therapy
试验速览
- 阶段
- 不适用
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- The difference between groups in the mean pre-operative Visual Analogue Scale.
研究概览
简要总结
Most women with breast cancer are able to have an operation to remove the cancer while preserving the breast (breast conserving therapy, BCT). Whilst cancer control is the most important goal, appearance of the breast after surgery has been shown to affect the quality of a woman's life after treatment. This is even more relevant now that most women are surviving breast cancer.
Before surgery, women are prepared for how they will look afterwards by having a discussion with the Surgeon or Breast Care Nurse. Sometimes women are shown two dimensional (2D) (standard) photographs of other women who had a similar operation. Patients have stated that viewing photographs of other patients does not prepare them adequately for their own experience of surgery.
Three dimensional (3D) digital photography is currently being used to predict the appearance of the breasts after enlargement surgery using specialist software. The investigators intend to use a similar system to simulate a patient's appearance after BCT for cancer. The investigators believe that this will lead women to feel better prepared for their surgery, reduce stress, and lead to greater satisfaction with their breast after treatment.
This study invites women undergoing BCT to be assigned at random to one of three groups receiving standard care (discussion), a 2D photograph, or the 3D simulation before their operation. The investigators will find out whether women feel better prepared for surgery and are more satisfied with their outcome if they are shown a simulated image of how their own breasts are likely to look.
By taking 3D photographs of all study patients before and after surgery, a more accurate way to predict appearance after surgery will be developed for future patients.
详细描述
Women who are planning to have breast conserving therapy (BCT) (surgery and radiotherapy, BCT) will be identified via two pathways: 1) via the Multi-Disciplinary Team Meeting (MDM) or 2) the consulting clinician. At their surgical outpatient appointment, the patients will be given written information to take away and read at their convenience. After at least 24 hours a member of the study team will telephone the patient to answer any further questions and to see whether they would like to be considered for the trial. Women who wish to participate will have a face-to-face meeting arranged with one of the co-investigators.
At the face-to-face meeting the investigators will go through the study in detail and ask the participant to sign a consent form to allow themselves to be included in the trial. The investigators will make it clear that participants can withdraw at any point during the study. The investigators will answer any further questions, take a baseline 3-D surface image (this is done by a member of the study team in a closed room with a lockable door with the offer of a chaperone), and issue a BCT BREAST-Q.
BCT BREAST-Q is a questionnaire which has been designed for women with breast cancer who are undergoing BCT to look at their quality of life and satisfaction with different aspects of their treatment and outcome. It is split into two sections, one to be filled in before, and one after treatment.
At the face-to-face meeting, the participants will be randomly allocated into 3 groups by a computer so the study team are not involved in the decision. This makes sure the allocation is fair. All women will receive the standard care for BCT which involves a conversation with surgeon and specialist breast care nurse.
Group 1 will receive standard care only. Group 2 will be shown photographs of women who have had BCT by a member of the study team .
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients Over 18 years Planned for unilateral breast conserving surgery at RMH Planned to receive adjuvant whole breast radiotherapy at RMH Willing to attend for study follow up visits.
排除标准
- •Previous or concurrent surgery to the contralateral breast (previous breast conserving surgery, breast reduction or mastectomy)
- •Previous surgery to the ipsilateral breast
- •Unable to stand for long enough to have clinical photos (approximately 5 minutes)
- •Unable to answer the BREAST-Q questionnaire (e.g. learning difficulties)
- •Visually impaired (so that they could not view a 2D/3D images)
- •Pre-operatively planning to have a symmetrisation procedure after radiotherapy.
研究组 & 干预措施
Standard Care
Patient receives standard pre-operative preparation which involves a discussion in to the likely aesthetic outcome with their surgeon or specialist nurse
2-dimensional Portfolio
Patient views photographs of women matched for BMI, age, and breast volume who are 1-5 years post BCT pre-operatively.
干预措施: Viewing of a 2-dimensional photographic library (Other)
3-dimensional simulation
Patient pre-operatively views a simulation of their own breast of their likely outcome after BCT.
干预措施: 3-dimensional photograph with simulation (Other)
结局指标
主要结局
The difference between groups in the mean pre-operative Visual Analogue Scale.
时间窗: preoperatively
The mean VAS score (range: 0 -10mm) will be compared between groups. It is intended to assess preparedness for surgery of the women in each of the three arms. Patient scores in answer to the question "How confident are you that you know how your breasts are likely to look after treatment?" will be measured for each patient following randomisation and completion of their pre-operative preparation depending on study group.
次要结局
- The differences in post-operative 'Satisfaction with Information' scores between the 3 groups(preoperatively , 3 months and 12 months)
- The difference in 'satisfaction with breasts' score pre and post-operatively between the 3 groups.(preoperatively , 3 months and 12 months)
- The difference in 'Quality of Life' score pre and post-operatively between the 3 groups.(preoperatively , 3 months and 12 months)