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 Among glioma patients , depression is estimated to be more prevalent than in both the general population and the cancer patient population . This can have negative consequences for both patients and their primary informal caregivers ( e.g. , a spouse , family member or close friend ) . At present , there is no evidence from r and omized controlled trials for the effectiveness of psychological treatment for depression in glioma patients . Furthermore , the possibility of delivering mental health care through the internet has not yet been explored in this population . Therefore , a r and omized controlled trial is warranted to evaluate the effects of an internet-based , guided self-help intervention for depressive symptoms in glioma patients . Methods / design The intervention is based on problem-solving therapy . An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms ( Center for Epidemiology Studies Depression Scale score ≥12 ) . Sample size calculations yield 126 glioma patients to be included , who are r and omly assigned to either the intervention group or a waiting list control group .  In addition , we aim to include 63 patients with haematological cancer in a non- central nervous system malignancy control group . Assessment s take place at baseline , after 6 and 12 weeks , and after 6 and 12 months . Primary outcome measure is the change in depressive symptoms . Secondary outcome measures include health-related quality of life , fatigue , costs and patient satisfaction . In addition , all patients are asked to assign a primary informal caregiver , who does not participate in the intervention but who is asked to complete similar assessment s. Their mood , health-related quality of life and fatigue is evaluated as well . Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients . If proven effective , this treatment will contribute to the mental health care of glioma patients in clinical practice .Trial registration Netherl and s Trial Register Abstract Depressive symptoms are common in glioma patients , and can negatively affect health-related quality of life ( HRQOL ) . We performed a nation-wide r and omized controlled trial to evaluate the effects of an online guided self-help intervention for depressive symptoms in adult glioma patients . Glioma patients with depressive symptoms were r and omized to a 5-week online course based on problem-solving therapy , or a waiting list control group . After having received the intervention , the glioma patient groups combined were compared with patients with cancer outside the central nervous system ( non-CNS cancer controls ) , who also received the intervention . Sample size calculations yielded 63 participants to be recruited per arm . The primary outcome [ depressive symptoms ( CES-D ) ] and secondary outcomes [ fatigue ( Checklist Individual Strength ( CIS ) ) and HRQOL ( Short Form-36 ) ] , were assessed online at baseline , post-intervention , and 3 and 12 months follow-up . In total , 89 glioma patients ( intervention N = 45 ; waiting list N = 44 ) and 26 non-CNS cancer controls were included , of whom 35 and 54 % completed the intervention , respectively . Recruitment could not be extended beyond 3.5 years due to funding . On depression , no statistically significant differences between the groups were found . Fatigue decreased post-treatment in the glioma intervention group compared with the waiting list group ( p = 0.054 , d = 0.306 ) . At 12 months , the physical component summary ( HRQOL ) remained stable in glioma patients , while scores improved in non-CNS cancer controls ( p = 0.035 , d = 0.883 ) . In this underpowered study , no evidence for the effectiveness of online guided self-help for depression or HRQOL in glioma patients was found , but it may improve fatigue . Trial registration Netherl and s Trial Register NTR3223 CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs Background Recent results of a r and omized clinical trial showed that a guided self-help intervention ( based on problem-solving therapy ) targeting psychological distress among head and neck cancer and lung cancer patients is effective . This study qualitatively explored motivation to start , experiences with and perceived outcomes of this intervention . Methods Data were collected from semi-structured interviews of 16 patients . All interviews were audio-recorded and transcribed verbatim . Data were analyzed individually by two coders and coded into key issues and themes . Results Patients participated in the intervention for intrinsic ( e.g. to help oneself ) and for extrinsic reasons ( e.g. being asked by a care professional or to help improve health care ) . Participants indicated positive and negative experiences with the intervention . Several participants appreciated participating as being a pleasant way to work on oneself , while others described participating as too confrontational . Some expressed their disappointment as they felt the intervention had brought them nothing or indicated that they felt worse temporarily , but most participants perceived positive outcomes of the intervention ( e.g. feeling less distressed and having learned what matters in life ) . Conclusions Cancer patients have various reasons to start a guided self-help intervention . Participants appreciated the guided self-help as intervention to address psychological distress , but there were also concerns . Most participants reported the intervention to be beneficial . The results suggest the need to identify patients who might benefit most from guided self-help targeting psychological distress and that interventions should be further tailored to individual cancer patients ’ requirements Objective This study qualitatively explored barriers and facilitators of adherence to an online psychological intervention for cancer-related distress . Methods Semi-structured interviews were conducted with 13 adults with cancer , r and omised to receive either a 6-week intervention ( n = 8) or attention control ( n = 5 ) as part of a larger RCT . Transcripts were coded for themes and subthemes , and recruitment ceased when saturation of themes occurred . Results Adherence overall was high : six participants completed all six modules , three completed five modules , two completed four modules , one completed one module , and one did not access the program . The total numbers of barriers ( n = 19 ) and facilitators ( n = 17 ) identified were equivalent and were categorised into five overarching themes : illness factors , psychological factors , personal factors , intervention factors and computer factors . However , the prevalence with which themes were discussed differed : illness factors ( specifically cancer treatment side effects ) were the main reported barrier to adherence ; intervention factors ( email reminders , program satisfaction , ease of use , program content ) were the most common facilitators . Conclusion While some factors were cited as both facilitating and barring adherence , and therefore reflective of personal preferences and circumstances , a number of recommendations were derived regarding ( i ) the best timing for online interventions and ( ii ) the need for multi-platform programs Background Internet-delivered interventions can effectively change health risk behaviors and their determinants , but adherence to these interventions once they are accessed is very low . Therefore , it is relevant and necessary to systematic ally manipulate website characteristics to test their effect on website use . This study focuses on user control as a website characteristic . Objective To test whether and how user control ( the freedom of choice to skip pages ) can increase website use and knowledge gained from the website . Methods Participants older than 18 years were drawn from the Dutch Internet population ( in June 2011 ) and completed a hepatitis knowledge question naire . Subsequently , they were r and omly assigned to three groups : ( 1 ) a tunneled version of the website with less user control ; ( 2 ) a high user control version of the website where visitors had the freedom of choice to skip pages ; and ( 3 ) a control group that was not exposed to the website . Participants completed ( 1 ) a question naire of vali date d measures regarding user perceptions immediately after exposure to the website ( except for the control group ) , and ( 2 ) a  hepatitis knowledge question naire after one week to test whether participants in the experimental groups only clicked through the website or actually processed and learned its content . Server registration s were used to assess website use . Analyses of covariance ( ANCOVA ) using all available data were conducted to determine whether user control increases website use . Structural equation models ( SEM ) using all available data were constructed to test how user control increases website use — a latent variable derived from number of pages visited and time on website . Results Of the 1044 persons invited to participate , 668 took part ( 668/1044 , 64.0 % ) . One half of participants ( 332/668 49.7 % ) were female and the mean age was 49 years ( SD 16 ) . A total of 571 participants completed the one-week follow-up measure regarding hepatitis knowledge ( 571/668 , 85.5 % ) . The findings demonstrate that having less user control ( ie , a tunneled version of the website ) had a negative effect on users ’ perception of efficiency ( F1,452 = 97.69 , P < .001 ) , but a positive effect on number of pages visited ( F1,452 = 171.49 , P < .001 ) , time on the website ( F1,452 = 6.32 , P = .01 ) , and knowledge gained from the website ( F1,452 = 134.32 , P < .001 ) . The direct effect of having less user control appeared to surpass the effect mediated by efficiency , because website use was higher among participants exposed to the tunneled version of the website in comparison with those having the freedom of choice to skip pages . Conclusions The key finding that visitors demonstrated increased website use in the tunneled version of the website indicates that visitors should be carefully guided through the intervention for future intervention websites Purpose To investigate and compare the effects of mobile health ( mHealth ) and pedometer with conventional exercise program using a brochure on physical function and quality of life ( QOL ) . Methods The study was a prospect i ve , quasi-r and omized multicenter trial where 356 patients whose cancer treatment had been terminated were enrolled . All patients were instructed to perform a 12-week regimen of aerobic and resistance exercise . The mHealth group received a pedometer and a newly developed smartphone application to provide information and monitor the prescribed exercises . Those in the conventional group received an exercise brochure . Physical measurements were conducted at baseline , 6 weeks , and 12 weeks . Self-reported physical activity ( international physical activity question naire-short form ) , general QOL ( European Organization for Research and Treatment of Cancer Quality of Life Question naire Core 30 ) , and breast cancer-specific QOL ( Quality of Life Question naire Breast Cancer Module 23 ) were assessed at baseline and 12 weeks . A user satisfaction survey was assessed in the mHealth group . Results Basic characteristics were not different between the two groups except for age and previous radiotherapy . Physical function , physical activity , and QOL scores were significantly improved regardless of the intervention method , and changes were not significantly different between the two groups . Additionally , the mean Likert scale response for overall satisfaction with the service was 4.27/5 in the mHealth group . Conclusions Overall , both the mHealth coupled with pedometer and conventional exercise education using a brochure were effective in improving physical function , physical activity , and QOL . This study provides a basis of mHealth research in breast cancer patients for progressing further developing field , although superiority of the mHealth over the conventional program was not definitely evident Background A cancer diagnosis elicits greater distress than any other medical diagnosis , and yet very few studies have evaluated the efficacy of structured online self-help therapeutic programs to alleviate this distress . This study aims to assess the efficacy over time of an internet Cognitive Behaviour Therapy ( iCBT ) intervention ( ‘ Finding My Way ’ ) in improving distress , coping and quality of life for individuals with a recent diagnosis of early stage cancer of any type . Methods / Design The study is a multi-site R and omised Controlled Trial ( RCT ) seeking to enrol 188 participants who will be r and omised to either the Finding My Way Intervention or an attention-control condition .  Both conditions are delivered online ; with 6 modules released once per week , and an additional booster module released one month after program-comple 
    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 Among glioma patients , depression is estimated to be more prevalent than in both the general population and the cancer patient population . This can have negative consequences for both patients and their primary informal caregivers ( e.g. , a spouse , family member or close friend ) . At present , there is no evidence from r and omized controlled trials for the effectiveness of psychological treatment for depression in glioma patients . Furthermore , the possibility of delivering mental health care through the internet has not yet been explored in this population . Therefore , a r and omized controlled trial is warranted to evaluate the effects of an internet-based , guided self-help intervention for depressive symptoms in glioma patients . Methods / design The intervention is based on problem-solving therapy . An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms ( Center for Epidemiology Studies Depression Scale score ≥12 ) . Sample size calculations yield 126 glioma patients to be included , who are r and omly assigned to either the intervention group or a waiting list control group .  In addition , we aim to include 63 patients with haematological cancer in a non- central nervous system malignancy control group . Assessment s take place at baseline , after 6 and 12 weeks , and after 6 and 12 months . Primary outcome measure is the change in depressive symptoms . Secondary outcome measures include health-related quality of life , fatigue , costs and patient satisfaction . In addition , all patients are asked to assign a primary informal caregiver , who does not participate in the intervention but who is asked to complete similar assessment s. Their mood , health-related quality of life and fatigue is evaluated as well . Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients . If proven effective , this treatment will contribute to the mental health care of glioma patients in clinical practice .Trial registration Netherl and s Trial Register Abstract Depressive symptoms are common in glioma patients , and can negatively affect health-related quality of life ( HRQOL ) . We performed a nation-wide r and omized controlled trial to evaluate the effects of an online guided self-help intervention for depressive symptoms in adult glioma patients . Glioma patients with depressive symptoms were r and omized to a 5-week online course based on problem-solving therapy , or a waiting list control group . After having received the intervention , the glioma patient groups combined were compared with patients with cancer outside the central nervous system ( non-CNS cancer controls ) , who also received the intervention . Sample size calculations yielded 63 participants to be recruited per arm . The primary outcome [ depressive symptoms ( CES-D ) ] and secondary outcomes [ fatigue ( Checklist Individual Strength ( CIS ) ) and HRQOL ( Short Form-36 ) ] , were assessed online at baseline , post-intervention , and 3 and 12 months follow-up . In total , 89 glioma patients ( intervention N = 45 ; waiting list N = 44 ) and 26 non-CNS cancer controls were included , of whom 35 and 54 % completed the intervention , respectively . Recruitment could not be extended beyond 3.5 years due to funding . On depression , no statistically significant differences between the groups were found . Fatigue decreased post-treatment in the glioma intervention group compared with the waiting list group ( p = 0.054 , d = 0.306 ) . At 12 months , the physical component summary ( HRQOL ) remained stable in glioma patients , while scores improved in non-CNS cancer controls ( p = 0.035 , d = 0.883 ) . In this underpowered study , no evidence for the effectiveness of online guided self-help for depression or HRQOL in glioma patients was found , but it may improve fatigue . Trial registration Netherl and s Trial Register NTR3223 CONTEXT The Consoli date d St and ards for Reporting of Trials ( CONSORT ) statement was developed to help improve the quality of reports of r and omized controlled trials ( RCTs ) . To date , a paucity of data exists regarding whether it has achieved this goal . OBJECTIVE To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs . DESIGN AND SETTING Comparative before- and -after evaluation in which reports of RCTs published in 1994 ( pre-CONSORT ) were compared with RCT reports from the same journals published in 1998 ( post-CONSORT ) . We included 211 reports from BMJ , JAMA , and The Lancet ( journals that adopted CONSORT ) as well as The New Engl and Journal of Medicine ( a journal that did not adopt CONSORT and was used as a comparator ) . MAIN OUTCOME MEASURES Number of CONSORT items included in a report , frequency of unclear reporting of allocation concealment , and overall trial quality score based on the Jadad scale , a 5-point quality assessment instrument . RESULTS Compared with 1994 , the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998 , and this increase was statistically significant for the 3 adopter journals ( pre-CONSORT , 23.4 ; mean change , 3.7 ; 95 % confidence interval [ CI ] , 2.1 - 5.3 ) . The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals , and this change was statistically significant for adopters ( pre-CONSORT , 61 % ; mean change , -22 % ; 95 % CI , -38 % to -6 % ) . Similarly , 3 of the 4 journals showed an improvement in the quality score for reports of RCTs , and this increase was statistically significant for adopter journals overall ( pre-CONSORT , 2.7 ; mean change , 0.4 ; 95 % CI , 0.1 - 0.8 ) . CONCLUSION Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs Background Recent results of a r and omized clinical trial showed that a guided self-help intervention ( based on problem-solving therapy ) targeting psychological distress among head and neck cancer and lung cancer patients is effective . This study qualitatively explored motivation to start , experiences with and perceived outcomes of this intervention . Methods Data were collected from semi-structured interviews of 16 patients . All interviews were audio-recorded and transcribed verbatim . Data were analyzed individually by two coders and coded into key issues and themes . Results Patients participated in the intervention for intrinsic ( e.g. to help oneself ) and for extrinsic reasons ( e.g. being asked by a care professional or to help improve health care ) . Participants indicated positive and negative experiences with the intervention . Several participants appreciated participating as being a pleasant way to work on oneself , while others described participating as too confrontational . Some expressed their disappointment as they felt the intervention had brought them nothing or indicated that they felt worse temporarily , but most participants perceived positive outcomes of the intervention ( e.g. feeling less distressed and having learned what matters in life ) . Conclusions Cancer patients have various reasons to start a guided self-help intervention . Participants appreciated the guided self-help as intervention to address psychological distress , but there were also concerns . Most participants reported the intervention to be beneficial . The results suggest the need to identify patients who might benefit most from guided self-help targeting psychological distress and that interventions should be further tailored to individual cancer patients ’ requirements Objective This study qualitatively explored barriers and facilitators of adherence to an online psychological intervention for cancer-related distress . Methods Semi-structured interviews were conducted with 13 adults with cancer , r and omised to receive either a 6-week intervention ( n = 8) or attention control ( n = 5 ) as part of a larger RCT . Transcripts were coded for themes and subthemes , and recruitment ceased when saturation of themes occurred . Results Adherence overall was high : six participants completed all six modules , three completed five modules , two completed four modules , one completed one module , and one did not access the program . The total numbers of barriers ( n = 19 ) and facilitators ( n = 17 ) identified were equivalent and were categorised into five overarching themes : illness factors , psychological factors , personal factors , intervention factors and computer factors . However , the prevalence with which themes were discussed differed : illness factors ( specifically cancer treatment side effects ) were the main reported barrier to adherence ; intervention factors ( email reminders , program satisfaction , ease of use , program content ) were the most common facilitators . Conclusion While some factors were cited as both facilitating and barring adherence , and therefore reflective of personal preferences and circumstances , a number of recommendations were derived regarding ( i ) the best timing for online interventions and ( ii ) the need for multi-platform programs Background Internet-delivered interventions can effectively change health risk behaviors and their determinants , but adherence to these interventions once they are accessed is very low . Therefore , it is relevant and necessary to systematic ally manipulate website characteristics to test their effect on website use . This study focuses on user control as a website characteristic . Objective To test whether and how user control ( the freedom of choice to skip pages ) can increase website use and knowledge gained from the website . Methods Participants older than 18 years were drawn from the Dutch Internet population ( in June 2011 ) and completed a hepatitis knowledge question naire . Subsequently , they were r and omly assigned to three groups : ( 1 ) a tunneled version of the website with less user control ; ( 2 ) a high user control version of the website where visitors had the freedom of choice to skip pages ; and ( 3 ) a control group that was not exposed to the website . Participants completed ( 1 ) a question naire of vali date d measures regarding user perceptions immediately after exposure to the website ( except for the control group ) , and ( 2 ) a  hepatitis knowledge question naire after one week to test whether participants in the experimental groups only clicked through the website or actually processed and learned its content . Server registration s were used to assess website use . Analyses of covariance ( ANCOVA ) using all available data were conducted to determine whether user control increases website use . Structural equation models ( SEM ) using all available data were constructed to test how user control increases website use — a latent variable derived from number of pages visited and time on website . Results Of the 1044 persons invited to participate , 668 took part ( 668/1044 , 64.0 % ) . One half of participants ( 332/668 49.7 % ) were female and the mean age was 49 years ( SD 16 ) . A total of 571 participants completed the one-week follow-up measure regarding hepatitis knowledge ( 571/668 , 85.5 % ) . The findings demonstrate that having less user control ( ie , a tunneled version of the website ) had a negative effect on users ’ perception of efficiency ( F1,452 = 97.69 , P < .001 ) , but a positive effect on number of pages visited ( F1,452 = 171.49 , P < .001 ) , time on the website ( F1,452 = 6.32 , P = .01 ) , and knowledge gained from the website ( F1,452 = 134.32 , P < .001 ) . The direct effect of having less user control appeared to surpass the effect mediated by efficiency , because website use was higher among participants exposed to the tunneled version of the website in comparison with those having the freedom of choice to skip pages . Conclusions The key finding that visitors demonstrated increased website use in the tunneled version of the website indicates that visitors should be carefully guided through the intervention for future intervention websites Purpose To investigate and compare the effects of mobile health ( mHealth ) and pedometer with conventional exercise program using a brochure on physical function and quality of life ( QOL ) . Methods The study was a prospect i ve , quasi-r and omized multicenter trial where 356 patients whose cancer treatment had been terminated were enrolled . All patients were instructed to perform a 12-week regimen of aerobic and resistance exercise . The mHealth group received a pedometer and a newly developed smartphone application to provide information and monitor the prescribed exercises . Those in the conventional group received an exercise brochure . Physical measurements were conducted at baseline , 6 weeks , and 12 weeks . Self-reported physical activity ( international physical activity question naire-short form ) , general QOL ( European Organization for Research and Treatment of Cancer Quality of Life Question naire Core 30 ) , and breast cancer-specific QOL ( Quality of Life Question naire Breast Cancer Module 23 ) were assessed at baseline and 12 weeks . A user satisfaction survey was assessed in the mHealth group . Results Basic characteristics were not different between the two groups except for age and previous radiotherapy . Physical function , physical activity , and QOL scores were significantly improved regardless of the intervention method , and changes were not significantly different between the two groups . Additionally , the mean Likert scale response for overall satisfaction with the service was 4.27/5 in the mHealth group . Conclusions Overall , both the mHealth coupled with pedometer and conventional exercise education using a brochure were effective in improving physical function , physical activity , and QOL . This study provides a basis of mHealth research in breast cancer patients for progressing further developing field , although superiority of the mHealth over the conventional program was not definitely evident Background A cancer diagnosis elicits greater distress than any other medical diagnosis , and yet very few studies have evaluated the efficacy of structured online self-help therapeutic programs to alleviate this distress . This study aims to assess the efficacy over time of an internet Cognitive Behaviour Therapy ( iCBT ) intervention ( ‘ Finding My Way ’ ) in improving distress , coping and quality of life for individuals with a recent diagnosis of early stage cancer of any type . Methods / Design The study is a multi-site R and omised Controlled Trial ( RCT ) seeking to enrol 188 participants who will be r and omised to either the Finding My Way Intervention or an attention-control condition .  Both conditions are delivered online ; with 6 modules released once per week , and an additional booster module released one month after program-comple 
    Output:
    