***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 conduct of r and omized , controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports . OBJECTIVE To develop an extension of the CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement for trials of nonpharmacologic treatments . DESIGN A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses r and omized trials of nonpharmacologic treatments . To prepare for the meeting , a survey was conducted to identify the specific issues for discussion . SETTING Consensus meeting in Paris , France . PARTICIPANTS A total of 33 experts attended the meeting . The experts were method ologists ( n = 17 ) ; surgeons ( n = 6 ) ; editors ( n = 5 ) ; and clinicians involved in rehabilitation ( n = 1 ) , psychotherapy ( n = 2 ) , education ( n = 1 ) , and implantable devices ( n = 1 ) . MEASUREMENTS Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments . During a 3-day consensus meeting , all items were discussed and additional method ological issues related to nonpharmacologic research were identified . RESULTS The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic trials : item 1 ( title and abstract ) , item 3 ( participants ) , item 4 ( interventions ) , item 7 ( sample size ) , item 8 ( r and omization ) , item 11 ( blinding ) , item 12 ( statistical methods ) , item 13 ( participant flow ) , item 15 ( baseline data ) , item 20 ( discussion : interpretation ) , and item 21 ( generalizability ) . In addition , the meeting participants added 1 item related to implementation of the intervention . LIMITATION Evidence was not always available to support the inclusion of each checklist item . CONCLUSION The methods and processes used to develop this extension could be used for other reporting guidelines . The use of this extension to the CONSORT Statement should improve the quality of reporting r and omized , controlled trials assessing nonpharmacologic treatments PURPOSE Early breast cancer survivors ( BCSs ) report high unmet care needs , and easily accessible care is not routinely available for this growing population . The Breast Cancer E-Health ( BREATH ) trial is a Web-based self-management intervention to support the psychological adjustment of women after primary treatment , by reducing distress and improving empowerment . PATIENTS AND METHODS This multicenter , r and omized , controlled , parallel-group trial evaluated whether care as usual ( CAU ) plus BREATH is superior to CAU alone . BREATH is delivered in sixteen fully automated weekly modules covering early survivorship issues . Two to 4 months post-treatment , BCSs were r and omly assigned to receive CAU + BREATH ( n = 70 ) or CAU alone ( n = 80 ) using a stratified block design ( ratio 1:1 ) . Primary outcomes were distress ( Symptom Checklist-90 ) and empowerment ( Cancer Empowerment Question naire ) , assessed before r and om assignment ( baseline , T0 ) and after 4 ( T1 ) , 6 ( T2 ) , and 10 months ( T3 ) of follow-up . Statistical ( analysis of covariance ) and clinical effects ( reliable change index ) were tested in an intention-to-treat analysis ( T0 to T1 ) . Follow-up effects ( T0 to T3 ) were assessed in assessment completers . RESULTS CAU + BREATH participants reported significantly less distress than CAU-alone participants ( -7.79 ; 95 % CI , -14.31 to -1.27 ; P = .02 ) with a small-to-medium effect size ( d = 0.33 ) , but empowerment was not affected ( -1.71 ; 95 % CI , 5.20 to -1.79 ; P = .34 ) . More CAU + BREATH participants ( 39 of 70 [ 56 % ] ; 95 % CI , 44.1 to 66.8 ) than CAU-alone participants ( 32 of 80 [ 40 % ] ; 95 % CI , 30.0 to 51.0 ) showed clinical ly significant improvement ( P = .03 ) . This clinical effect was most prominent in low-distress BCSs . Secondary outcomes confirmed primary outcomes . There were no between-group differences in primary outcomes during follow-up . CONCLUSION Access to BREATH reduced distress among BCSs , but this effect was not sustained during follow-up Background : Internet-based methods for provision of psychological support and intervention to cancer survivors hold promise for increasing the public impact of such treatments . Purpose : The goal of this controlled pilot study was to examine the effect and potential mechanisms of action of a self-guided , Internet-based coping-skills training group on quality of life outcomes in women with early-stage breast cancer . Methods : Sixty-two women completed baseline evaluations and were r and omized into either a small online coping group or a waiting-list control condition . Results : No main effects for treatment were observed at the 12-week follow up . However , there was a significant interaction between baseline self-reported health status and treatment , such that women with poorer self-perceived health status showed greater improvement in perceived health over time when assigned to the treatment condition . Linguistic analyses revealed that positive changes across quality of life variables were associated with greater expression of negative emotions such as sadness and anxiety , greater cognitive processing , and lower expression of health-related concerns . Conclusions : These results demonstrate the potential efficacy of self-guided Internet coping groups while highlighting the limitations of such groups The aims of this study were to ( a ) identify the predictors of attrition from a fully self-directed intervention , and ( b ) to test whether an intervention to increase gratitude is an effective way to reduce body dissatisfaction .  Participants ( N=479 , from the United Kingdom ) aged 18 - 76 years took part in a self-help study via the Internet  and were r and omized to receive one of two interventions , gratitude diaries ( n=130 ) , or thought monitoring and restructuring ( n=118 ) or a waitlist control ( n=231 ) for a two week body dissatisfaction intervention . The gratitude intervention ( n=40 ) was as effective as monitoring and restructuring ( n=22 ) in reducing body dissatisfaction , and both interventions were significantly more effective than the control condition ( n=120 ) . Participants in the gratitude group were more than twice as likely to complete the intervention compared to those in the monitoring and restructuring group . Intervention content , baseline expectancy and internal locus of control significantly predicted attrition . This study shows that a  gratitude intervention  can be as effective as a technique commonly used in cognitive therapy and is superior in retaining participants . Prediction of attrition is possible from both intervention content and psychological variables BACKGROUND The aim of this study was to evaluate the short-term effectiveness of the web-based computer-tailored intervention Kanker Nazorg Wijzer ( Cancer Aftercare Guide ) . The intervention aims to support cancer survivors with managing psychosocial and lifestyle-related issues . In this study , the impact on quality of life , anxiety , depression , and fatigue were evaluated . METHODS Cancer survivors were recruited through 21 Dutch hospitals ( November 2013-June 2014 ) . Outcome measures included quality of life ( European Organization for Research and Treatment of Cancer Quality of Life Question naire-C30 ) , anxiety and depression ( Hospital Anxiety and Depression Scale ) , and fatigue ( Checklist Individual Strength ) . In a r and omized controlled trial with an intervention group ( n = 231 ) and a waiting list control group ( n = 231 ) , the short-term effectiveness was evaluated through multilevel linear regression analyses , controlling for selective dropout , baseline differences , and several demographic and disease-related characteristics . RESULTS In total , 188 participants of the intervention group and 221 of the control group completed the 6-month measurement ( dropout = 11.5 % ) . The intervention was effective in reducing depression ( B = -0.63 , p = 0.007 , f2 = 0.019 , d = 0.21 ) and fatigue ( B = -4.36 , p = 0.020 , f2 = 0.013 , d = 0.21 ) . In addition , effects were found for emotional ( B = 3.47 , p = 0.022 , f2 = 0.013 , d = 0.15 ) and social functioning ( B = 3.95 , p = 0.011 , f2 = 0.017 , d = 0.15 ) , although this evidence was less strong . There were indications that the effects of fatigue and social functioning were influenced by module use . CONCLUSIONS While effect sizes were small , they can be considered as clinical ly relevant . With the Cancer Aftercare Guide being an effective , low-intensive , and easy accessible intervention , it could serve as a first step in stepped care for needs assessment and initial support for psychosocial problems that are present after cancer treatment . Copyright © 2016 John Wiley & Sons , Addressing psychosocial and quality of life needs is central to provision of excellent care for people with advanced cancer . This study tested a brief nurse-delivered intervention to address the needs of urban women with advanced breast cancer . This study was conducted at four large urban hospitals in Australia . One hundred and five women with advanced breast cancer were recruited and r and omised to receive the intervention or usual care , then asked to complete the European Organisation of Research and Treatment of Quality of life Q-C30 version ( 2.0 ) ( EORTC Q-C30 ) ( version 2 ) and Supportive Care Needs Survey ( SCNS ) at 1 month and 3 months postrecruitment . No significant differences were detected between intervention and usual care groups in the SCNS or the EORTC Q-C30 subscale scores . However , when the groups were divided into high needs ( score of above 50 ) and low baseline needs ( score of 50 or below ) for each SCNS subscale , a significant difference between intervention and usual care groups was found in the psychological/emotional subscale among women with high baseline needs . In conclusions , this study demonstrated that a face-to-face session and follow-up phone call with a breast care nurse significantly reduced the psychological and emotional needs of those with high initial needs . There was no evidence of the intervention influencing the quality of life ; or perceived needs of women with low initial psychological/emotional needs or perceived needs in other domains . Possibly , the intervention was not sufficiently intense to achieve an effect BACKGROUND Prostate cancer ( PCa ) poses many emotional and physical challenges for men following treatment . The unmet support needs of these men are well documented , and access to psychosocial support remains problematic . OBJECTIVES To assess the efficacy of an online psychological intervention for men who have localised PCa . DESIGN , SETTING , AND PARTICIPANTS We undertook a r and omised controlled trial to evaluate the intervention . Participants were r and omly allocated to one of three conditions :  My Road Ahead ( MRA ) alone ( MRA Only ) , MRA plus access to an online forum ( MRA+Forum ) , and access to the forum alone ( Forum ) . INTERVENTION The intervention was a 10-week self-guided online psychological intervention called My Road Ahead that consisted of six themed modules design ed to facilitate improved emotional well-being in the context of PCa as well as a moderated peer forum . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Pre- and postintervention assessment s of psychological distress ( the 21- question Depression , Anxiety and Stress Scale ) [ 1 ] and the Prostate Cancer-related Quality of Life scale [ 2 ] were conducted . Multivariate analysis of variance , regression , and structural equation modelling were used to analyse the data . RESULTS AND LIMITATIONS In total , 142 participants were r and omly allocated to one of the three intervention arms . The mean age of participants was 61 yr of age ( st and ard deviation : 7 ) , and 88 % had undergone radical prostatectomy . A significant improvement in psychological distress was observed for participants who had access to the combined condition ( MRA+Forum ) with a moderate effect size ( p=0.02 ; partial η(2)=0.07 ) . In particular , the decline in the mean level of psychological distress was 8.8 units larger for the MRA+Forum group than the Forum group ( 95 % confidence interval [ CI ] , 0.9 - 16.7 ) . Although the decline in the mean level of psychological distress was 7.0 units larger for the MRA+Forum group than for the MRA Only group , this difference was not significant ( 95 % CI , 1.1 - 15.1 ) . Structural equation modelling indicated that reductions in health worry and regret contributed significantly to the reductions in psychological distress for the MRA+Forum condition . CONCLUSIONS This study is the first , to our knowledge , that has evaluated a self-guided online psychological intervention tailored to the specific needs of men who have PCa . The findings of this study indicate the potential for this programme to deliver support that men may not otherwise receive . PATIENT SUMMARY This study found that men who have localised prostate cancer who received access to the online psychological intervention called My Road Ahead combined with the online peer discussion forum had significantly improved reductions in distress compared with those who received access to the online intervention alone or the forum alone PURPOSE A first breast cancer recurrence creates considerable distress , yet few psychosocial interventions directed at this population have been reported . The Southwest Oncology Group conducted a phase III r and omized trial to evaluate the effectiveness of a brief telephone intervention . PATIENTS AND METHODS Three hundred five women experiencing a first 
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No evidence of survival benefit was found .
Group programs had the strongest evidence -base for efficacy ; individual and low-intensity therapy had insufficient evidence to form conclusions .
Group interventions had longest intervention duration s and lowest uptake and adherence ; low-intensity interventions had shortest duration s and highest uptake and adherence .
Disparities in uptake , adherence , and reach were evident , with the demographic profile of participants polarised to young , Caucasian , English-speaking , partnered women .
CONCLUSIONS There remains a paucity of psychological interventions for women with metastatic breast cancer .
Those that exist have an inconsistent evidence -base across the range of patient-reported outcomes .