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

NCT ID: NCT03131011

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-10
• Study Completion Date: 2019-04-23

Brief 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.

Detailed 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.

Conditions

Breast Cancer Female; Body Image Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

UV fluorescent ink

Intervention Type: OTHER

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.

Arm 2 - Black ink

Radiotherapy tattoos will be applied using standard black ink.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CancerCare Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Kim, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

CancerCare Manitoba

Erin V Toews, B.Sc., RTT

Role: PRINCIPAL_INVESTIGATOR

CancerCare Manitoba

Locations

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

RRIC 2017-011

Identifier Type: -

Identifier Source: org_study_id