Status:
COMPLETED
Physical and Psychological Effects of Different Temperature-controlled Breast Prostheses on Patients With Breast Cancer
Lead Sponsor:
Fudan University
Conditions:
External Breast Prostheses
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Breast loss causes negative influence on women physically, psychologically and socially. Breast prosthesis can improve patient's figure externally, increase self-confidence, thus improving quality of ...
Detailed Description
Breast loss causes negative influence on women physically, psychologically and socially. Breast prosthesis can improve patient's figure externally, increase self-confidence, thus improving quality of ...
Eligibility Criteria
Inclusion
- undergoing unilateral mastectomy due to breast cancer confirmed by histological examination
- had undergone mastectomy at least six months prior to the start of the study or patients who completed radiation therapy at least two months prior
- without evidence of postoperative relapse
- wearing conventional (non-adhesive) breast prostheses
- without abnormal skin or skin lesions
- patients without progressive lymphedema;
- interested in conventional and self-adhesive breast prostheses.
Exclusion
- with incomplete healing of their surgical wounds
- undergoing chemoradiotherapy or who received chemoradiotherapy less than two months prior to the beginning of the study
- with skin conditions that do not meet the requirements
- whose remaining breast is not within the study's size range
- with significant life changes during the study, including divorce, unemployment or depression; 6) relapsed during the observation period
- had a reaction to the first skin test and who were not able to receive the second skin test.
Key Trial Info
Start Date :
October 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03830294
Start Date
October 10 2016
End Date
June 30 2017
Last Update
February 5 2019
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