A double blinded randomized controlled trial of women with breast cancer who have had mastectomy followed by implant based reconstruction to assess signs and symptoms of capsular contracture following treatment with laser therapy.

Breast & Surgical Oncology at The Poche Centre0 个研究点目标入组 40 人开始时间: 2015年6月17日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Previous recruitment to either the:
•Immediate expander/implant breast reconstruction followed by post-mastectomy radiotherapy for breast cancer: Aesthetic and quality of life outcomes” study (the RT Study) (ACTRN12614000078651).
•A pilot study to assess the feasibility of prospective assessment of a comprehensive set of patient-reported outcomes that impact on Quality of Life of women undergoing Immediate, Delayed and no breast reconstruction following mastectomy and adjuvant radiotherapy for breast cancer (the QoLID Study). (ACTRN 12614000045617).
•Non-trial patients, identified through clinic records, who meet the following criteria:
•1. Undergone mastectomy for breast cancer
•2. Completed their definitive implant-based reconstruction at least six months ago
•3. Willing to complete a pre-treatment patient questionnaire to assess their degree of capsular contracture
•4. Have clinically detectible capsular contracture based on the score derived from the pre-treatment questionnaire
•5. Able to read and write English to a level required for completion of informed consent and questionnaires.
•6. Willing to participate and comply with the study requirements.

•1. Pregnancy
•2. Any metastatic disease other than stable bone metastases.
•3. Unable to read and write English to a level required for consent and completion of written questionnaires.
•4. Unwilling to provide consent.

发起方

Breast & Surgical Oncology at The Poche Centre