Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos

Breast Cancer Female Clinical Trial

— SPOT  

Official title:

Body-image Satisfaction Following Permanent Black or Invisible UV Ink Tattoos for Localization of Adjuvant Radiotherapy Fields in Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03131011
• Other study ID #: RRIC 2017-011
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: April 23, 2019

Study information

• Verified date: July 2018
• Source: CancerCare Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: April 23, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female age 18-60.

• 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 1.

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Body Image Disturbance
• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• UV fluorescent ink
The use of UV tattoo ink results in a tattoo that is visible only under an ultraviolet light. Conventional black tattoo ink is replaced with UV ink for the application of radiotherapy "dot" tattoos. Handheld UV flashlights are used to make the tattoos visible for use during radiotherapy treatment set-up.

Locations

Country	Name	City	State
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
CancerCare Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body-image scale score	Mean BIS scores at each time point will be calculated along with standard deviation and will be compared using the student t-test.	Day 0, Week 3, Week 12
Secondary	Set-up Accuracy	Set-up accuracy will be assessed using orthogonal image sets from fractions 1, 2, 3 & one day treatment week 2 for each participant. Pre-imaging couch angle, vertical, longitudinal and lateral positions will be compared to the post-imaging values and evaluated based on our departmental couch adjustment tolerances for image-guided radiation therapy.	Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Secondary	Resource Requirements (Tattooing procedure length)	The average time(Min) it takes to complete the tattooing procedure during simulation will be collected and compared between the two arms.	Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Secondary	Resource Requirements (Treatment set-up procedure length)	The average time(Min) it takes to complete daily treatment set-up will be collected and compared between the two arms.	Day 0 Simulation appointment, Radiation Treatment week 1 (fractions 1, 2, 3) and Treatment week 2 (one fraction)
Secondary	Radiation Therapist Evaluation Survey of UV Tattoo Method	Clinical practicability will be evaluated qualitatively through feedback from radiation therapists through a survey measuring their satisfaction with the UV tattooing method.	Week 13