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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-10

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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External Breast Prostheses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Self-adhesive Group

The participants used the adhesive breast prosthesis that adheres to the skin.

Group Type EXPERIMENTAL

different temperature-controlled breast prostheses

Intervention Type OTHER

Two types of temperature-controlled breast prostheses were applied to patients in each group

Conventional Group

The participants used the conventional breast prosthesis that was placed inside a bra and did not directly adhere to the skin.

Group Type ACTIVE_COMPARATOR

different temperature-controlled breast prostheses

Intervention Type OTHER

Two types of temperature-controlled breast prostheses were applied to patients in each group

Interventions

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different temperature-controlled breast prostheses

Two types of temperature-controlled breast prostheses were applied to patients in each group

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No