Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos for Localization of Adjuvant Radiotherapy Fields in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Change in Body-image scale score
研究概览
简要总结
A phase II prospective, randomized control trial assessing the impact of "invisible ink" ultra-violet (UV) tattoo ink versus conventional black tattoo ink for radiotherapy treatment localization on the quality of life of breast cancer patients undergoing adjuvant radiotherapy. The effect of tattoo type on quality of life will be measured objectively using the externally validated body-image satisfaction (BIS) scale as the primary outcome of interest, with secondary endpoints including: accuracy/reproducibility of radiotherapy setup using the invisible ink tattoos, resource impact requirements, and clinical feasibility. A sample size of 60 patients is planned (30 per study arm) with an anticipated accrual period of 18 months.
详细描述
Breast cancer patients ages 18-60 who are planned for adjuvant radiotherapy and who meet all inclusion/exclusion criteria will be offered voluntary participation in this trial. Recruitment will be open for approximately 18 months; it is anticipated that 1-2 patients will be recruited per week until the planned sample size is met. Participants will be stratified into three groups depending on their self-reported baseline Body-image satisfaction (BIS) score and will then be randomly allocated to receive conventional dark ink or UV fluorescent tattoos using permutated block randomization (4 patients per block) to ensure balance of BIS baseline average between study arms.
The investigators focus is to improve the current tattooing technique for breast cancer patients by introducing an alternate method that takes the patient's psychological perceptions of tattooing into account while first and foremost, continuing to guarantee that the current standard of accuracy in treatment delivery is maintained or improved. The investigators goal of decreasing the psychological effect of permanent radiotherapy tattoos aligns with CancerCare Manitoba's mission to improve the outcomes and quality of life for Manitobans with cancer.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female age 18-
- •Histologically confirmed early stage invasive ductal or lobular carcinoma of a single breast (T1N0M0-T2N0M0) or DCIS/LCIS (TisNxMx or TisN0M0) of a single breast.
- •Deemed fit to undergo adjuvant radiotherapy to their breast by their supervising radiation oncologist.
- •Able to provide written informed consent.
- •Must be willing to be contacted by e-mail and have a valid e-mail account to complete follow up self-reported body image scale questionnaires.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Intact skin at site of standard radiotherapy tattoos. Must have access to a computer and be able and willing to comply with requirements of the protocol.
排除标准
- •History of any prior radiotherapy courses to the chest or abdomen.
- •Metastatic disease.
- •Node positive breast cancer.
- •Bilateral breast cancer or bilateral DCIS/LCIS.
- •Deep-inspiration breath hold radiotherapy technique.
- •Unable or unwilling to comply with the requirements of the protocol as assessed by the study investigator or coordinator.
研究组 & 干预措施
Arm 1 - UV ink
Radiotherapy tattoos will be applied using an invisible UV fluorescent ink that can only be detected while illuminated with a special ultraviolet flashlight.
干预措施: UV fluorescent ink (Other)
Arm 2 - Black ink
Radiotherapy tattoos will be applied using standard black ink.
结局指标
主要结局
Change in Body-image scale score
时间窗: Day 0, Week 3, Week 12
Mean BIS scores at each time point will be calculated along with standard deviation and will be compared using the student t-test.
次要结局
- Resource Requirements (Tattooing procedure length)(Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction))
- Set-up Accuracy(Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction))
- Resource Requirements (Treatment set-up procedure length)(Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction))
- Radiation Therapist Evaluation Survey of UV Tattoo Method(Week 13)