human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background The incidence of head and neck cancer is increasing slightly . Head and neck cancer but also it ’s necessary and often successful treatment may affect general domains of health-related quality of life and provoke a variety of adverse symptoms and side effects , both during and after treatment . The objective of this study was to compare a person-centred care intervention in terms of health-related quality of life , disease-specific symptoms or problems , with traditional care as a control group for patients with head and neck cancer . Methods In this r and omized controlled trial ,  person – centred-care intervention and traditional care ( control ) groups comprised 54 and 42 patients , respectively . Outcome measures used were : the EORTC QLQ-C30 and the EORTC QLQ-C35 . Both groups answered the question naires at baseline and after 4 , 10 , 18 and 52 weeks from start of treatment . The question naires ’ scores were compared between groups by using independent sample s test and non-parametric test for continuous variables . For categorical data , Fisher ’s exact test was used . Longitudinal data were analysed using generalized linear models for normally distributed repeated measures data . Results At baseline , the intervention and control groups were comparable in terms of medical and sociodemographic variables , clinical characteristics , health-related quality of life and disease-specific symptoms or problems . At all the follow-up points , even during the worst period for the patients , the person-centred-care group consistently reported better scores than the control group . The differences were numerically but not always statistically significant . When testing longitudinal data , statistically significant results were found for head and neck cancer-specific problems , swallowing ( p = 0.014 ) , social eating ( p = 0.048 ) and feeling ill ( p = 0.021 ) . Conclusions The results from this study suggest that adopting the person-centred-care concept practice d here could be a way to improve function and wellbeing in patients with head and neck cancer . Trial registration The study was retrospectively registered in 2016 - 12 - 05 in Clinical Trials gov . “ Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer ” registration number : NCT02982746 Goals of the work Patients with head and neck cancer have complex needs that affect many basic functions of life and contribute to substantial psychosocial problems . The aim of this study was to evaluate the effectiveness of a problem-focused intervention for patients with psychosocial dysfunction who had completed treatment for head and neck cancer . Patients and methods Using a quasi-experimental design , 54 participants who were above pre-determined cutoff points for psychosocial dysfunction ( hospital and depression scale , work and social adjustment scale ) were given the opportunity to self-select into either the experimental group for the psychosocial intervention programme which was delivered in an individualised format , with bibliotherapy as an adjunct , or the control group for usual care . Main results Analysis of covariance results demonstrated a reduction in psychological distress ( anxiety , p = 0.001 ; depression , p = 0.005 ) , improving social functioning ( p = 0.048 ) and quality of life scores ( p = < 0.05 ) for the experimental group , all of which were sustained into the 3-month follow-up period . No such improvements were evident for the control group . Conclusions This study suggests that head and neck cancer patients with post-treatment psychosocial dysfunction  can benefit from a problem-focused psychosocial intervention . Such evidence can inform practice , policy and future research , aim ed at improving post-treatment quality of life for patients with head and neck cancer BACKGROUND A longitudinal , prospect i ve , case-control study evaluated if a psychosocial support program improved health-related quality of life ( HRQL ) in head and neck ( H&N ) cancer patients . METHODS One hundred forty-four H&N cancer patients were included : 52 study patients and 92 controls . The study group met the support team repeatedly throughout the first year after diagnosis . HRQL was assessed three times during the first year and after 3 years using the EORTC QLQ-C30 , EORTC QLQ-H&N35 , and HADS . RESULTS A few statistically significant differences were found , all favoring the controls . Controls reported better global quality of life after 1 year and felt less ill after 3 years . Depression and treatment-related side effects were prevalent in both groups . CONCLUSIONS Our psychosocial support program did not improve HRQL in H&N cancer patients . Its effectiveness may be improved by evaluating and actively integrating HRQL assessment s during the program , thereby enabling rapid and adequate symptomatic treatment and /or psychologic intervention OBJECTIVE The purpose of this study was to evaluate the effects of a skin camouflage program on disfigurement , self-esteem , social interaction , and body image in female head and neck cancer ( HNC ) survivors . METHODS A prospect i ve , repeated- measures , r and omized controlled therapeutic intervention design was used . A total of 66 participants were r and omly assigned to each group , with 32 in the experimental group and 34 in the control group . The experimental group received a 4-session skin camouflage program , and the control group received routine care . Patients were assessed at 3 time points : baseline assessment ( T0 ) and then at 1 , 2 , and 3 months ( T1 , T2 , and T3 , respectively ) after participating in the skin camouflage program . RESULTS Patients in the experimental group had significantly less facial disfigurement , depression , fear of social interaction , and anxiety regarding social interaction compared with those in the control group . Participants in both groups had significantly lower levels of facial disfigurement , depression , fear of social interaction , anxiety of social interaction , and body image at the final posttest assessment than at the pretest assessment . There were no differences between the groups and within groups with respect to self-esteem . CONCLUSIONS The 3-month skin camouflage program effectively improved facial disfigurement , fear of social interaction , anxiety of social interaction , and body image of female HNC survivors . A survival care plan should include a skin camouflage program to improve body image perception and decrease anxiety after treatment of HNC Background : Head and neck cancer ( HNC ) patients are prone to have a poor health-related quality of life after cancer treatment . This study investigated the effect of the nurse counselling and after intervention ( NUCAI ) on the health-related quality of life and depressive symptoms of HNC patients between 12 and 24 months after cancer treatment . Methods : Two hundred and five HNC patients were r and omly allocated to NUCAI ( N=103 ) or usual care ( N=102 ) . The 12-month nurse-led NUCAI is problem-focused and patient-driven and aims to help HNC patients manage with the physical , psychological and social consequences of their disease and its treatment . Health-related quality of life was evaluated with the EORTC QLQ-C30 and QLQ H&N35 . Depressive symptoms were evaluated with the CES-D. Results : At 12 months the intervention group showed a significant ( P<0.05 ) improvement in emotional and physical functioning , pain , swallowing , social contact , mouth opening and depressive symptoms . At 18 months , global quality of life , role and emotional functioning , pain , swallowing , mouth opening and depressive symptoms were significantly better in the intervention group than in the control group , and at 24 months emotional functioning and fatigue were significantly better in the intervention group . Conclusion : The NUCAI effectively improved several domains of health-related quality of life and depressive symptoms in HNC patients and would seem a promising intervention for implementation in daily clinical practice Long-term survivors of head and neck cancer may suffer from psychological distress and reduced quality of life because of late side-effects of the treatment . In a follow-up study of patients r and omised to two different radiation fractionating regimens , 204 patients filled in a mailed question naire 7 - 11 years after treatment . The question naire consisted of the General Health Question naire , 20-item version ( GHQ-20 ) , and the EORTC Core Quality of Life Question naire ( EORTC QLQ-C30 ) . There were no differences in psychological distress between patients receiving conventional radiotherapy  and those receiving a slightly hypofractionated regimen .  A high prevalence of psychological distress was found in both treatment groups ( 30 % of ' cases ' according to the GHQ-20 ) , especially in patients with impaired cognitive or social function , or with pain . Clinicians need to be aware of this morbidity , and their ability to detect patients with psychological problems needs to be improved . The GHQ-20 can facilitate the communication process in a clinical setting . With an increased awareness of these problems and by using valid instruments for identification of patients at risk , the clinicians may intervene and help the patients to reduce their psychological distress BACKGROUND Many patients with head and neck cancer ( HNC ) experience depressive symptoms after treatment . This r and omized controlled trial investigated the effects of a psychosocial nurse counseling and after intervention ( NUCAI ) versus usual care on the depressive and HNC-related physical symptoms of patients with HNC at 1 year after diagnosis . METHODS A total of 205 patients with HNC were r and omly assigned to either intervention ( n = 103 ) or usual care ( n = 102 ) , with stratification for gender and tumor stage . The NUCAI , which consisted of six bimonthly 45-minute counseling sessions , was a problem-focused intervention aim ed at helping patients to manage the physical , psychological , and social consequences of HNC and its treatment . It was nurse-led and offered in combination with regular medical follow-up visits at the University Medical Center Utrecht , the Netherl and s. Depressive symptoms at 1 year after diagnosis were the primary outcome . Analyses were performed on an intention-to-treat basis for the total sample and for a predefined subgroup of patients with raised levels of depressive symptoms ( Center for Epidemiologic Studies -Depression score ≥ 12 ; n = 91 ) at baseline using mixed-effect models . RESULTS One year after HNC treatment , levels of depressive symptoms were significantly lower in the intervention group than in the control group in the total sample and in the subgroup of patients with raised levels of depressive symptoms . CONCLUSION The NUCAI was feasible and effective in reducing depressive symptoms in patients with HNC 1 year after HNC treatment , and especially in patients with raised levels of depressive symptoms . The results of this study need to be confirmed in future studies before the NUCAI can be used in daily clinical practice BACKGROUND Many critical appraisal tools ( CATs ) exist for which there is little or no information on development of the CAT , evaluation of validity , or testing reliability . The proposed CAT was developed based on a number of other CATs , general research methods theory , and reporting guidelines but requires further study to determine its effectiveness . OBJECTIVES To establish a scoring system and to evaluate the construct validity of the proposed critical appraisal tool before undertaking reliability testing . METHODS Data obtained from this exploratory study along with information on the design of the proposed CAT were combined to evaluate construct validity using the St and ards for educational and psychological testing which consist of five types of evidence : test content , response process , internal structure , relations to other variables , and consequences of testing . To obtain data for internal structure and relations to other variables , the proposed CAT was analysed against five alternative CATs . A r and om sample of 10 papers from six different research design s across the range of health related research were selected , giving a total sample size of 60 papers . RESULTS In all research design s , the proposed CAT had significant ( p<0.05 , two-tailed ) weak to moderate positive correlations ( Kendall 's τ 0.33 - 0.55 ) with the alternative CATs , except in the Preamble category . There were significant moderate to strong positive correlations in the quasi-experimental ( τ 0.70 - 1.00 ) , descriptive/exploratory/observational ( τ 0.72 - 1.00 ) , qualitative ( τ 0.74 - 0.81 ) , and systematic review ( τ 0.62 - 0.82 ) design s and to a lesser extent in the true experimental ( τ 0.68 - 0.70 ) design . There were no significant correlations in the single system research design s. CONCLUSIONS Based on the results obtained , the theory on which the proposed CAT was design ed , and the objective of the proposed CAT there was enough evidence to show that inferences made from scores obtained from the proposed CAT should be sound To test the feasibility of providing a psycho-educational intervention for people with head and neck ( H&N ) cancer . A prospect i ve non-r and omized design was used . Subjects were patients with H&N cancer . They were offered the Nucare coping strategies program in one of three formats : small group and one-to-one formats with therapists ; and a home format , with material for home use , without a therapist . Outcomes measures ( quality of life ( QOL ) and anxiety and depression ) were collected at baseline and following the intervention . Analyses were performed using non-parametric statistics . Of 128 people invited to participate , 66 agreed , 59 completed the intervention and 50 had outcomes data . Following the intervention , there were significant improvements in physical and social functioning and global QOL , and reduced fatigue , sleep disturbance and depressive symptoms . These data suggest that the intervention may have some beneficial effects , although an appropriately design ed study is required to confirm this OBJECTIVE Oral cancer elicits considerable distress in both the pre and post-treatment periods . This paper details the development , validation and pilot-testing of a psychoeducational intervention for oral cancer patients . METHOD An educational booklet covering information about oral cancer and its treatment and effective coping strategies was developed by a multi-disciplinary team . It was evaluated by patient focus groups and content/educational experts , delivered to subjects in pre and post-operative presentations by 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background The incidence of head and neck cancer is increasing slightly . Head and neck cancer but also it ’s necessary and often successful treatment may affect general domains of health-related quality of life and provoke a variety of adverse symptoms and side effects , both during and after treatment . The objective of this study was to compare a person-centred care intervention in terms of health-related quality of life , disease-specific symptoms or problems , with traditional care as a control group for patients with head and neck cancer . Methods In this r and omized controlled trial ,  person – centred-care intervention and traditional care ( control ) groups comprised 54 and 42 patients , respectively . Outcome measures used were : the EORTC QLQ-C30 and the EORTC QLQ-C35 . Both groups answered the question naires at baseline and after 4 , 10 , 18 and 52 weeks from start of treatment . The question naires ’ scores were compared between groups by using independent sample s test and non-parametric test for continuous variables . For categorical data , Fisher ’s exact test was used . Longitudinal data were analysed using generalized linear models for normally distributed repeated measures data . Results At baseline , the intervention and control groups were comparable in terms of medical and sociodemographic variables , clinical characteristics , health-related quality of life and disease-specific symptoms or problems . At all the follow-up points , even during the worst period for the patients , the person-centred-care group consistently reported better scores than the control group . The differences were numerically but not always statistically significant . When testing longitudinal data , statistically significant results were found for head and neck cancer-specific problems , swallowing ( p = 0.014 ) , social eating ( p = 0.048 ) and feeling ill ( p = 0.021 ) . Conclusions The results from this study suggest that adopting the person-centred-care concept practice d here could be a way to improve function and wellbeing in patients with head and neck cancer . Trial registration The study was retrospectively registered in 2016 - 12 - 05 in Clinical Trials gov . “ Can a Person-centred-care Intervention Improve Health-related Quality of Life in Patients With Head and Neck Cancer ” registration number : NCT02982746 Goals of the work Patients with head and neck cancer have complex needs that affect many basic functions of life and contribute to substantial psychosocial problems . The aim of this study was to evaluate the effectiveness of a problem-focused intervention for patients with psychosocial dysfunction who had completed treatment for head and neck cancer . Patients and methods Using a quasi-experimental design , 54 participants who were above pre-determined cutoff points for psychosocial dysfunction ( hospital and depression scale , work and social adjustment scale ) were given the opportunity to self-select into either the experimental group for the psychosocial intervention programme which was delivered in an individualised format , with bibliotherapy as an adjunct , or the control group for usual care . Main results Analysis of covariance results demonstrated a reduction in psychological distress ( anxiety , p = 0.001 ; depression , p = 0.005 ) , improving social functioning ( p = 0.048 ) and quality of life scores ( p = < 0.05 ) for the experimental group , all of which were sustained into the 3-month follow-up period . No such improvements were evident for the control group . Conclusions This study suggests that head and neck cancer patients with post-treatment psychosocial dysfunction  can benefit from a problem-focused psychosocial intervention . Such evidence can inform practice , policy and future research , aim ed at improving post-treatment quality of life for patients with head and neck cancer BACKGROUND A longitudinal , prospect i ve , case-control study evaluated if a psychosocial support program improved health-related quality of life ( HRQL ) in head and neck ( H&N ) cancer patients . METHODS One hundred forty-four H&N cancer patients were included : 52 study patients and 92 controls . The study group met the support team repeatedly throughout the first year after diagnosis . HRQL was assessed three times during the first year and after 3 years using the EORTC QLQ-C30 , EORTC QLQ-H&N35 , and HADS . RESULTS A few statistically significant differences were found , all favoring the controls . Controls reported better global quality of life after 1 year and felt less ill after 3 years . Depression and treatment-related side effects were prevalent in both groups . CONCLUSIONS Our psychosocial support program did not improve HRQL in H&N cancer patients . Its effectiveness may be improved by evaluating and actively integrating HRQL assessment s during the program , thereby enabling rapid and adequate symptomatic treatment and /or psychologic intervention OBJECTIVE The purpose of this study was to evaluate the effects of a skin camouflage program on disfigurement , self-esteem , social interaction , and body image in female head and neck cancer ( HNC ) survivors . METHODS A prospect i ve , repeated- measures , r and omized controlled therapeutic intervention design was used . A total of 66 participants were r and omly assigned to each group , with 32 in the experimental group and 34 in the control group . The experimental group received a 4-session skin camouflage program , and the control group received routine care . Patients were assessed at 3 time points : baseline assessment ( T0 ) and then at 1 , 2 , and 3 months ( T1 , T2 , and T3 , respectively ) after participating in the skin camouflage program . RESULTS Patients in the experimental group had significantly less facial disfigurement , depression , fear of social interaction , and anxiety regarding social interaction compared with those in the control group . Participants in both groups had significantly lower levels of facial disfigurement , depression , fear of social interaction , anxiety of social interaction , and body image at the final posttest assessment than at the pretest assessment . There were no differences between the groups and within groups with respect to self-esteem . CONCLUSIONS The 3-month skin camouflage program effectively improved facial disfigurement , fear of social interaction , anxiety of social interaction , and body image of female HNC survivors . A survival care plan should include a skin camouflage program to improve body image perception and decrease anxiety after treatment of HNC Background : Head and neck cancer ( HNC ) patients are prone to have a poor health-related quality of life after cancer treatment . This study investigated the effect of the nurse counselling and after intervention ( NUCAI ) on the health-related quality of life and depressive symptoms of HNC patients between 12 and 24 months after cancer treatment . Methods : Two hundred and five HNC patients were r and omly allocated to NUCAI ( N=103 ) or usual care ( N=102 ) . The 12-month nurse-led NUCAI is problem-focused and patient-driven and aims to help HNC patients manage with the physical , psychological and social consequences of their disease and its treatment . Health-related quality of life was evaluated with the EORTC QLQ-C30 and QLQ H&N35 . Depressive symptoms were evaluated with the CES-D. Results : At 12 months the intervention group showed a significant ( P<0.05 ) improvement in emotional and physical functioning , pain , swallowing , social contact , mouth opening and depressive symptoms . At 18 months , global quality of life , role and emotional functioning , pain , swallowing , mouth opening and depressive symptoms were significantly better in the intervention group than in the control group , and at 24 months emotional functioning and fatigue were significantly better in the intervention group . Conclusion : The NUCAI effectively improved several domains of health-related quality of life and depressive symptoms in HNC patients and would seem a promising intervention for implementation in daily clinical practice Long-term survivors of head and neck cancer may suffer from psychological distress and reduced quality of life because of late side-effects of the treatment . In a follow-up study of patients r and omised to two different radiation fractionating regimens , 204 patients filled in a mailed question naire 7 - 11 years after treatment . The question naire consisted of the General Health Question naire , 20-item version ( GHQ-20 ) , and the EORTC Core Quality of Life Question naire ( EORTC QLQ-C30 ) . There were no differences in psychological distress between patients receiving conventional radiotherapy  and those receiving a slightly hypofractionated regimen .  A high prevalence of psychological distress was found in both treatment groups ( 30 % of ' cases ' according to the GHQ-20 ) , especially in patients with impaired cognitive or social function , or with pain . Clinicians need to be aware of this morbidity , and their ability to detect patients with psychological problems needs to be improved . The GHQ-20 can facilitate the communication process in a clinical setting . With an increased awareness of these problems and by using valid instruments for identification of patients at risk , the clinicians may intervene and help the patients to reduce their psychological distress BACKGROUND Many patients with head and neck cancer ( HNC ) experience depressive symptoms after treatment . This r and omized controlled trial investigated the effects of a psychosocial nurse counseling and after intervention ( NUCAI ) versus usual care on the depressive and HNC-related physical symptoms of patients with HNC at 1 year after diagnosis . METHODS A total of 205 patients with HNC were r and omly assigned to either intervention ( n = 103 ) or usual care ( n = 102 ) , with stratification for gender and tumor stage . The NUCAI , which consisted of six bimonthly 45-minute counseling sessions , was a problem-focused intervention aim ed at helping patients to manage the physical , psychological , and social consequences of HNC and its treatment . It was nurse-led and offered in combination with regular medical follow-up visits at the University Medical Center Utrecht , the Netherl and s. Depressive symptoms at 1 year after diagnosis were the primary outcome . Analyses were performed on an intention-to-treat basis for the total sample and for a predefined subgroup of patients with raised levels of depressive symptoms ( Center for Epidemiologic Studies -Depression score ≥ 12 ; n = 91 ) at baseline using mixed-effect models . RESULTS One year after HNC treatment , levels of depressive symptoms were significantly lower in the intervention group than in the control group in the total sample and in the subgroup of patients with raised levels of depressive symptoms . CONCLUSION The NUCAI was feasible and effective in reducing depressive symptoms in patients with HNC 1 year after HNC treatment , and especially in patients with raised levels of depressive symptoms . The results of this study need to be confirmed in future studies before the NUCAI can be used in daily clinical practice BACKGROUND Many critical appraisal tools ( CATs ) exist for which there is little or no information on development of the CAT , evaluation of validity , or testing reliability . The proposed CAT was developed based on a number of other CATs , general research methods theory , and reporting guidelines but requires further study to determine its effectiveness . OBJECTIVES To establish a scoring system and to evaluate the construct validity of the proposed critical appraisal tool before undertaking reliability testing . METHODS Data obtained from this exploratory study along with information on the design of the proposed CAT were combined to evaluate construct validity using the St and ards for educational and psychological testing which consist of five types of evidence : test content , response process , internal structure , relations to other variables , and consequences of testing . To obtain data for internal structure and relations to other variables , the proposed CAT was analysed against five alternative CATs . A r and om sample of 10 papers from six different research design s across the range of health related research were selected , giving a total sample size of 60 papers . RESULTS In all research design s , the proposed CAT had significant ( p<0.05 , two-tailed ) weak to moderate positive correlations ( Kendall 's τ 0.33 - 0.55 ) with the alternative CATs , except in the Preamble category . There were significant moderate to strong positive correlations in the quasi-experimental ( τ 0.70 - 1.00 ) , descriptive/exploratory/observational ( τ 0.72 - 1.00 ) , qualitative ( τ 0.74 - 0.81 ) , and systematic review ( τ 0.62 - 0.82 ) design s and to a lesser extent in the true experimental ( τ 0.68 - 0.70 ) design . There were no significant correlations in the single system research design s. CONCLUSIONS Based on the results obtained , the theory on which the proposed CAT was design ed , and the objective of the proposed CAT there was enough evidence to show that inferences made from scores obtained from the proposed CAT should be sound To test the feasibility of providing a psycho-educational intervention for people with head and neck ( H&N ) cancer . A prospect i ve non-r and omized design was used . Subjects were patients with H&N cancer . They were offered the Nucare coping strategies program in one of three formats : small group and one-to-one formats with therapists ; and a home format , with material for home use , without a therapist . Outcomes measures ( quality of life ( QOL ) and anxiety and depression ) were collected at baseline and following the intervention . Analyses were performed using non-parametric statistics . Of 128 people invited to participate , 66 agreed , 59 completed the intervention and 50 had outcomes data . Following the intervention , there were significant improvements in physical and social functioning and global QOL , and reduced fatigue , sleep disturbance and depressive symptoms . These data suggest that the intervention may have some beneficial effects , although an appropriately design ed study is required to confirm this OBJECTIVE Oral cancer elicits considerable distress in both the pre and post-treatment periods . This paper details the development , validation and pilot-testing of a psychoeducational intervention for oral cancer patients . METHOD An educational booklet covering information about oral cancer and its treatment and effective coping strategies was developed by a multi-disciplinary team . It was evaluated by patient focus groups and content/educational experts , delivered to subjects in pre and post-operative presentations by 
    Output:
    