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NCT Number: NCT03830294

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

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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Key information

Conditions

External Breast Prostheses Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

different temperature-controlled breast prostheses

Other

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

Primary outcomes

  1. Participants' skin condition

    Time frame: 12 weeks

    Scars and skin conditions: these examinations were performed by the same investigator.

  2. Participants' knowledge with regard to the breast prosthesis

    Time frame: 12 weeks

    A self-designed questionnaire covering a total of 11 items was used, including sources the patients used to obtain information on breast prostheses, reasons for choosing the breast prosthesis, its type and price, and the patient's feelings about wearing their breast prosthesis.

  3. Participants' feeling of the comfort and practicality of breast prostheses

    Time frame: 12 weeks

    A self-designed questionnaire covering a total of 10 items regarding the breast prostheses was used, including skin adhesion, practicality in daily life, maintainability, comfort, natural fit, contact, safety, and effects on the shoulder and back

  4. Measurement of Quality of life of the participants

    Time frame: 12 weeks

    We use breast cancer (QLICP-BR) to measure patients' quality of life.the QLICP-BR selected the following 37 items: 6 items in physical functional dimensions (PH), 12 items in psychological functional dimensions (PS), 8 items in symptoms and side effects dimensions (ST), 10 items in social functional dimensions (SOs) and 1 item in overall health condition.

  5. Measurement of Body Image of the participants

    Time frame: 12 weeks

    The Body Image Scale (BIS) is a self-assessment scale designed to assess cancer patients' perceptions of their appearance and identify any changes to those perceptions resulting from a disease or a treatment.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Physical and Psychological Effects of Different Temperature-controlled Breast Prostheses on Patients With Breast Cancer During Rehabilitation: a Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2019
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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