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

CancerCare Manitoba

Status: Terminated

Conditions: Breast Cancer Female; Body Image Disturbance

Treatments: Other: UV fluorescent ink

Study type: Interventional

Funder types: Other

Identifiers

NCT03131011

RRIC 2017-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Arm 1 - UV ink

Experimental group

Description:

Radiotherapy tattoos will be applied using an invisible UV fluorescent ink that can only be detected while illuminated with a special ultraviolet flashlight.

Treatment:

Other: UV fluorescent ink

Arm 2 - Black ink

No Intervention group

Description:

Radiotherapy tattoos will be applied using standard black ink.