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

NCT03830294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-02-05

No results posted yet for this study

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.

Conditions

  • External Breast Prostheses

Interventions

OTHER

different temperature-controlled breast prostheses

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-10
Primary Completion
2017-05-31
Completion
2017-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03830294 on ClinicalTrials.gov