Quality of Life Clinical Trial
— IMFDHACOfficial title:
Patients With Head and Neck Cancer Treated by Radiotherapy: The Impact of Fixed Dentures on Wellbeing and Oral Health Related Quality of Life
Verified date | March 2021 |
Source | Region Jönköping County |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the multi centre study is to evaluate an intervention, which means that patients undergoing radiotherapy for head and neck cancer will receive fixed dentures in accordance with the Public Health Care fee system with regard to well-being and oral health related quality of life. Hypotheses: the intervention will improve oral health related quality of life, general wellbeing, and nutrition in patients treated by radiotherapy, with or without combination of chemotherapy or surgery against head and neck cancer.
Status | Completed |
Enrollment | 64 |
Est. completion date | September 17, 2021 |
Est. primary completion date | September 17, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with head and neck tumours considered to receive radiotherapy, with or without combination of chemotherapy or surgery - Good oncological prognosis at baseline. - Patients diagnosed with dental infections and therapy planned for dental extraction(s). Exclusion Criteria: - Unwillingness to participate in the study. - Patients with communication problems. - Patients with comorbidity with poor prognosis. - Patients with poor oncological prognosis at baseline. - Patients with imminent risk of recurrence. - Patients with any technical, biological, or any other reasonable obstacle of treating patients with fixed dentures - Patients in the matched control group financing fixed oral prosthesis themselves. |
Country | Name | City | State |
---|---|---|---|
Sweden | Public Dental Health | Jönköping |
Lead Sponsor | Collaborator |
---|---|
Region Jönköping County | Malmö University, School of Health Sciences, Jönköping University, Jönköping Sweden |
Sweden,
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* Note: There are 30 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oral Health Related Quality of Life (OHRQL), OHIP-14, BL/T1 | Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available. | Baseline | |
Primary | Oral Health Related Quality of Life (OHRQL), OHIP-14, T2 | Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available. | 6 months after completed radiotherapy | |
Primary | Oral Health Related Quality of Life (OHRQL), OHIP-14, T3 | Specific quality of life measured by the Oral Health Impact Profile (OHIP-14). OHRQL measurements are constructed to provide information about oral symptoms and related psychosocial and functional problems in dental public health perspectives as well as in clinical trials. Thus, when identifying and selecting a measure of OHRQL it is essential to use one with acceptable reliability and validity measuring the intended aims of the research. OHIP-14 is an instrument consisting of 14 items. Range 14 (better OHRQL) to 70 (worse OHRQL). It was designed to provide a comprehensive measure of the dysfunction, discomfort and disability attributed to oral conditions. Validated Swedish versions of the OHIP-14 are available. | 12 months after completed radiotherapy | |
Primary | Oral Health Related Quality of Life (OHRQL), GOHAI, BL/T1 | Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated. | Baseline | |
Primary | Oral Health Related Quality of Life (OHRQL), GOHAI, T2 | Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated. | 6 months after completed radiotherapy | |
Primary | Oral Health Related Quality of Life (OHRQL), GOHAI, T3 | Specific quality of life measured by the General Oral Health Assessment Index (GOHAI) which is a 12-item instrument originally developed for use with older adult populations, although more recently it has been used with populations of younger adults. Range 12 (worse OHRQL) to 60 (better OHRQL). It measures oral functional problems and also assesses the psychosocial impacts associated with oral disease. A Swedish version has been validated. | 12 months after completed radiotherapy | |
Secondary | Wellbeing, Quality of Life (QoL), SF-36v2, BL/T1 | General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish. | Baseline | |
Secondary | Wellbeing, Quality of Life (QoL), SF-36v2, T2 | General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish. | 6 months after completed radiotherapy | |
Secondary | Wellbeing, Quality of Life (QoL), SF-36v2, T3 | General quality of life measured by the SF-36 v2. SF-36v2 is a well established psychometric instrument with 36 items measuring eight domains of health-related quality of life: Physical function, physical role function, bodily pain, general health, vitality, social function, emotional role function, mental health. The two comprehensive indices - physical health and mental health - can be estimated for. Range 0 (worse QoL) to 100 (better QoL). The instrument is translated and validated into Swedish. | 12 months after completed radiotherapy | |
Secondary | Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, BL/T1 | General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish. | Baseline | |
Secondary | Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T2 | General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish. | 6 months after completed radiotherapy | |
Secondary | Wellbeing, Health Related Quality of Life (HRQoL), EQ-5D, T3 | General quality of life measured by the EQ-5D which is an instrument containing five items measuring mobility, self-care, pain, role function, and anxiety/depression. There is also one item considering change of health condition and a VAS scale for general health. There is no total score, however there are different levels of HRQoL: Level 1. better HRQoL; Level 3. worse HRQoL. This instrument is translated and validated into Swedish. | 12 months after completed radiotherapy |
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