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

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

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.

Study Overview

• Status: Terminated
• Conditions: Body Image Disturbance; Breast Cancer Female
• Intervention / Treatment: Other: UV fluorescent ink

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Arm 2 - Black ink; Radiotherapy tattoos will be applied using standard black ink.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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

Collaborators and Investigators

• Sponsor: CancerCare Manitoba
• Investigators: Principal Investigator: Julian Kim, MD, MSc, CancerCare Manitoba; Principal Investigator: Erin V Toews, B.Sc., RTT, CancerCare Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Actual): April 23, 2019
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RRIC 2017-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No