Patient Reported Outcomes Using Mepitel Film During Radiotherapy
Condition: Radiodermatitis; Breast Neoplasms; Side Effect
MeSH terms: Breast Neoplasms; Radiodermatitis
Study type: Interventional

Summary: 
      Breast cancer patients in post-operative radiotherapy (RT) often experience acute skin
      reactions like erythema, pain, itching and oversensitivity. In 2014 a New Zealand randomized
      controlled trial (RCT) investigated the prophylactic use of safetac-based film, Mepitel Film,
      on half of the breast during RT compared to cream, resulting in significant differences in
      skin moist desquamation (0% vs. 26%). Despite changes in treatment modalities in Denmark
      toward lower total RT doses, the level of RT-induced skin toxicity could still be of great
      importance for the patients. The aim of this study is patient-reported symptoms and
      patient-reported experiences with the prophylactic use of Mepitel Film compared to standard
      cream treatment.
    

Detailed description: 
      Aim:

      The use of Mepitel Film in the RCT from New Zealand resulted in significant differences in
      the acute morbidity of the skin. However, the clinical experience in Denmark with the new RT
      treatment modalities for breast cancer patients with lower total doses and less treatment
      fractions indicate less severe skin toxicity than the old treatment modalities.

      The primary endpoint of this study is to investigate if prophylactic use of Mepitel Film to
      prevent severe skin reactions makes a difference for the patient experience of their RT
      induced skin reactions compared to treating the symptoms when they appear according to
      present clinical guidelines. Additional to the patient-reported experiences with the
      prophylactic use of Mepitel Film, the patients are asked to report their acute symptoms from
      the skin in the area with or without Mepitel Film at the end of treatment and two weeks after
      treatment. A secondary endpoint was a blinded radiotherapy staff evaluation of dermatitis.

      Method:

      The study was a multicenter trial with participation of three Danish hospitals: Aarhus
      University Hospital (Herning site), Vejle Hospital, and Odense University Hospital.

      For all patients either the lateral or medial part of the treatment area was covered by film
      based on a randomization; making the patients their own control.

      The randomization procedure was conducted by assigned radiotherapists (RTTs) at each hospital
      in the online system RedCap (Research Electronic Data Capture) provided by Odense Patient
      Data Explorative Network (OPEN). A block randomization was conducted stratifying for hospital
      to balance at each institution the number of patients having film applied at the medial or
      lateral part of the chest.

      A questionnaire was developed.consisting of four sections. Two sections with patient-reported
      outcome measures (PROM) regarding skin symptoms. Furthermore, a section with patient-reported
      experience measures (PREM) related to the use and preference of the barrier film and finally
      a section for staff evaluation of dermatitis.

      The PROM-questionnaire was developed guided by existing validated questionnaires
      (RISRAS-scale [14], and the breast cancer specific EORTC-questionnaire [15]). The answers
      were categorized on a 4-Point Likert Scale (not at all, a little, some, a lot).

      The PREM-questionnaire consisted of seven questions regarding comfort and preferences with a
      4-point Likert scale (strongly agree, mildly agree, mildly disagree, strongly disagree) and a
      scale for grading overall health and overall QOL. The questionnaires were cognitively
      validated by 3 patients.

      The patients were asked to fill out the paper-based questionnaire on the day of their final
      radiotherapy treatment and a similar one at the two week follow-up.
    

Intervention name(s): Mepitel Film
Intervention type(s): Other
Intervention description(s): A safetac-based barrier film with a clinically insignificant bolus effect to protect the skin during radiotherapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention