Physical and Psychological Effects of Different Temperature-controlled Breast Prostheses on Patients With Breast Cancer

Fudan University

Status

Completed

Conditions

External Breast Prostheses

Treatments

Other: different temperature-controlled breast prostheses

Study type

Interventional

Funder types

Other

Identifiers

NCT03830294

IRB1403133-2

Details and patient eligibility

About

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 life. The objective was to understand the knowledge regarding breast prostheses in breast cancer patients, evaluate the quality of life of patients wearing different types of breast prostheses and to compare the physical and psychological effects of different temperature-controlled breast prostheses on patients. The investigators designed a randomized control study in one cancer center in Shanghai. In the first 6 weeks of the study, self-adhesive breast prostheses and conventional breast prostheses were used in the intervention and control group, respectively. In the later 6 weeks, the breast prostheses used were switched into another kind. Several dimensional parameters were examined by different questionnaires at the end of both 6th and 12th week including scars and skin, survey of breast prosthesis knowledge, survey assessing the comfort and practicality of breast prostheses, quality of life instruments for cancer patients and body image scale. The investigators expected that women would be satisfied with the temperature-controlled breast prosthesis and were more willing to choose self-adhesive breast prostheses.

Full 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 life. Prospective study of different breast prostheses has not yet been performed in China. The objective was to understand the knowledge regarding breast prostheses in breast cancer patients, evaluate the quality of life of patients wearing different types of breast prostheses and to compare the physical and psychological effects of different temperature-controlled breast prostheses on patients. The investigators designed a randomized control study in one cancer center in Shanghai. Eligible participants were randomized into either intervention or control group. In the first 6 weeks of the study, self-adhesive breast prostheses and conventional breast prostheses were used in the intervention and control group, respectively. In the later 6 weeks, the breast prostheses used were switched into another kind. Several dimensional parameters were examined by different questionnaires at the end of both 6th and 12th week including scars and skin, survey of breast prosthesis knowledge, survey assessing the comfort and practicality of breast prostheses, quality of life instruments for cancer patients and body image scale. The investigators expected that women would be satisfied with the temperature-controlled breast prosthesis and were more willing to choose self-adhesive breast prostheses.

Enrollment

30 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.