Clinical trial NCT03830294: Physical and Psychological Effects of Different Temperature-controlled Breast Prostheses on Patients With Breast Cancer
Official title: Physical and Psychological Effects of Different Temperature-controlled Breast Prostheses on Patients With Breast Cancer During Rehabilitation: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: External Breast Prostheses
Keywords: breast prostheses, physical, psychological, breast cancer,
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participants' skin condition
timeFrame: 12 weeks
measure: Participants' knowledge with regard to the breast prosthesis
timeFrame: 12 weeks
measure: Participants' feeling of the comfort and practicality of breast prostheses
timeFrame: 12 weeks
measure: Measurement of Quality of life of the participants
timeFrame: 12 weeks
measure: Measurement of Body Image of the participants
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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