Quality of life in patients with facial prosthesis

Quality of life in patients with facial prosthesis - Quality of life in patients with facial prosthesis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36001

Enrollment

135

Registered

2011-01-28

Start date

2011-04-06

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

defect in het gelaat nvt

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Primary diagnosis of head- and neck cancer, including melanoma, treated with ablative surgery . * At least one year tumour free * Reconstructed with a facial prosthesis of the ear, orbita or nose. * Reconstruction occurred between 1 and 10 years ago. * Age between 18 and 85 years. * Frequent (at least once a year) consultation of the anaplastologists.;* Patients with other facial defects caused by surgery or trauma. (These patients will not be included in the study group, though they will be asked to fill in the QOL-, Body Image and facial prosthesis questionnaire.)

Exclusion criteria

Exclusion criteria: *Patients who are incompetent in answering questionnaires due to mental disorders or limiting co-morbidity.

Design outcomes

Primary

Measure	Time frame
For comparison and statistical analysis the patient group will be subdivided into those with an ear prosthesis, nose prosthesis, eye prosthesis and composite prosthesis. Furthermore, the group will be subdivided into those using an adhesive, magnets or a click system. Statistical analyses will be preformed with the Statistical Package for Social Sciences (SPSS). The quality of life subscales (general, anxiety, depression, satisfaction, head and neck specific) of this patient group will be compared to those of the general population with comparable demographic features (sex, age, socio-economic status, postal code). A regression analyses will be used to determine if these socio-demographic and clinical variables are significant with the quality of life results. The influence of age, time passed since the surgery , sex, etc will be correlated with these QOL measures. The body image scale will be correlated with QOL as well as the different types of prostheses and defects. The coping strategy after facial reconstruction is important for the satisfaction (12). It is likely to think that patients with a facial prosthesis cope in a similar way. It takes time to coping with facial disfigurement (21). In this analysis will be distinguished if patient are reconstructed with a prosthesis; recently (1-2 years ago), moderate (3-5 years ago) or in the last (>5 years ago). Data collected by means of the in-depth interviews will be analyzed by means of a process of coding (26). To facilitate and standardize this process the software program NVivo will be used, and to obtain a structured description of patients* lived through experience, codes will be further analyzed according to the (empirical) phenomenological method (27-29). The interviewer(s) will analyze the data together with Prof. G. Widdershoven and Dr. J Slatman. The specific aim of the qualitative data analysis is to identify (various) patterns of embodied self-experiences in people with	—

Measure

Time frame

For comparison and statistical analysis the patient group will be subdivided into those with an ear prosthesis, nose prosthesis, eye prosthesis and composite prosthesis. Furthermore, the group will be subdivided into those using an adhesive, magnets or a click system. Statistical analyses will be preformed with the Statistical Package for Social Sciences (SPSS). The quality of life subscales (general, anxiety, depression, satisfaction, head and neck specific) of this patient group will be compared to those of the general population with comparable demographic features (sex, age, socio-economic status, postal code). A regression analyses will be used to determine if these socio-demographic and clinical variables are significant with the quality of life results. The influence of age, time passed since the surgery **, sex, etc will be correlated with these QOL measures. The body image scale will be correlated with QOL as well as the different types of prostheses and defects. ** The coping strategy after facial reconstruction is important for the satisfaction (12). It is likely to think that patients with a facial prosthesis cope in a similar way. It takes time to coping with facial disfigurement (21). In this analysis will be distinguished if patient are reconstructed with a prosthesis; recently (1-2 years ago), moderate (3-5 years ago) or in the last (>5 years ago). Data collected by means of the in-depth interviews will be analyzed by means of a process of coding (26). To facilitate and standardize this process the software program NVivo will be used, and to obtain a structured description of patients* lived through experience, codes will be further analyzed according to the (empirical) phenomenological method (27-29). The interviewer(s) will analyze the data together with Prof. G. Widdershoven and Dr. J Slatman. The specific aim of the qualitative data analysis is to identify (various) *patterns* of embodied self-experiences in people with

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Secondary

Measure	Time frame
nvt	—

Countries

Netherlands

Outcome results