***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: The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care To evaluate the efficacy and economic efficiency of a multimedia , multimodal physical activity program for women undergoing adjuvant therapy following surgery for breast cancer . We conducted a r and omized trial with concurrent incremental cost-effectiveness analysis and blinded baseline , 3 , 6 and 12-month follow-up assessment s amongst women undergoing adjuvant therapy following surgery for breast cancer ( n = 89 ) . The intervention was a multimedia , multimodal exercise program comprising strength , balance and endurance training elements . The control was sham flexibility and relaxation program delivered using similar material s. The primary outcome was health-related quality of life ( EQ-5D & VAS , EORTC C30 , BR23 ) . Economic outcomes included direct health care costs and productivity gains and losses . Participants in the intervention group demonstrated greater improvement in health-related quality of life between baseline and the 3-month assessment [ mean ( sd ) EQ-5D VAS ( 0–100 ) baseline : 72.6 ( 15.6 ) , 3 month : 80.6 ( 11.6 ) ] when compared to control group participants [ baseline : 77.5 ( 13.5 ) , 3 month : 74.1 ( 20.6 ) , P = 0.006 ] and also improved more in terms of physical function [ mean ( sd ) EORTC C30 physical function scale intervention ( 0–100 ) baseline : 84.9 ( 14.8 ) , 3 month : 86.9 ( 10.7 ) , control baseline : 91.3 ( 9.6 ) , 3 month : 86.7 ( 14.9 ) , P = 0.02 ] . These improvements were not sustained beyond this point . Upper limb volumes were also lower amongst intervention group participants . However , there was low probability that the intervention would be both less costly and more effective than the control condition ( range probability = 0.05–50.02 % depending on approach ) . Provision of multimodal exercise programs will improve the short-term health of women undergoing adjuvant therapy for breast cancer but are of question able economic efficiency BACKGROUND During the last decade , survival rates for breast cancer have increased as a result of earlier detection and increased use of adjuvant therapy . Limited data exist on the psychosocial aspects of the transitional period between the end of primary treatment and survivorship . We investigated the baseline psychosocial status of women enrolled in a r and omized trial testing two psychosocial interventions for women at the end of primary treatment . METHODS Participants , identified within 1 month after surgery ( registration ) , provided demographic information and limited measures of quality of life . They were followed until they finished primary treatment ( enrollment ) , at which time they completed a mailed baseline survey that included st and ardized measures of quality of life ( including st and ardized scales of physical and emotional functioning ) , mood , symptoms , and sexual functioning .  A total of 558 patients ( mean age = 56.9 years ) were enrolled in the study between July 1 , 1999 , and June 30 , 2002 . Health outcomes were examined according to treatment received : mastectomy with and without chemotherapy , and lumpectomy with and without chemotherapy . All statistical tests were two-sided . RESULTS Among all treatment groups , patients who had a mastectomy had the poorest physical functioning at registration ( P<.001 ) and at enrollment ( P=.05 ) . At enrollment , mood and emotional functioning were similar among all patients , with no differences by type of treatment received . At enrollment , symptoms , including muscle stiffness , breast sensitivity , aches and pains , tendency to take naps , and difficulty concentrating , were common among patients in all groups and were statistically significantly associated with poor physical functioning and emotional well-being . Sexual functioning was worse for women who received chemotherapy than for those who did not , regardless of type of surgery ( P<.001 ) . CONCLUSIONS At the end of primary treatment for breast cancer , women in all treatment groups report good emotional functioning but report decreased physical functioning , particularly among women who have a mastectomy or receive chemotherapy . Clinical interventions to address common symptoms associated with treatment should be considered to improve physical and emotional functioning at the end of primary treatment for breast cancer PURPOSE We aim to assess any association between study and self-reported conflict of interest ( COI ) or trial sponsorship in breast cancer radiation clinical trials . MATERIAL S AND METHODS We search ed PubMed for all clinical trials ( CTs ) published between 09/2004 and 09/2014 related to breast cancer . We included only radiotherapy CTs with primary clinical endpoints . We classified eligible trials according to the funding source , presence or absence of conflict of interest , study conclusion and impact factor ( IF ) . RESULTS 1,603 CTs were retrieved . 72 r and omized clinical trials were included for analysis . For-profit ( PO ) , not for profit organization ( nPO ) , none and not reported sponsorship rates were 9/72 ( 12.5 % ) , 35/72 ( 48.6 % ) , 1/72 ( 1.4 % ) , 27/72 ( 37.5 % ) , respectively . Present , absent or not reported COI were found in 6/72 ( 8.3 % ) , 43/72 ( 59.7 % ) and 23/72 ( 32 % ) of the CTs , respectively . Conclusion was positive , neutral and negative in 57/72 ( 79.1 % ) , 9/72 ( 12.5 % ) and 6/72 ( 8.4 % ) of the trials , respectively . Positive conclusion was reported in 33/44 ( 75 % ) funded trials ( PO and nPO ) and 5/6 ( 83.3 % ) CTs with reported COI . On univariate analysis no association with funding source ( P=0.178 ) , COI ( P=0.678 ) or trial region ( P=0.567 ) and trial positive conclusion was found . Sponsored trials ( HR 4.50 , 95CI-0.1.23 - 16.53;P=0.0023 ) and positive trials ( HR 4.78 , 95CI- 1.16 - 19.63;P=0.030 ) were more likely to be published in higher impact factor journals in the multivariate analysis . CONCLUSIONS nPO funding was reported in almost 50 % of the evaluated CTs . No significant association between study conclusion and funding source , COI or trial region was identified . Sponsored trials and positive trials were more likely to be published in higher impact factor journals OBJECTIVES This study compares the effects of an integrated yoga program with brief supportive therapy in breast cancer out patients undergoing adjuvant radiotherapy at a cancer centre . METHODS Eighty-eight stage II and III breast cancer out patients were r and omly assigned to receive yoga ( n = 44 ) or brief supportive therapy ( n = 44 ) prior to their radiotherapy treatment . Intervention consisted of yoga sessions lasting 60 min daily while the control group was imparted supportive therapy once in 10 days . Assessment s included European Organization for Research in the Treatment of Cancer- Quality of Life ( EORTCQoL C30 ) functional scales and Positive and Negative Affect Schedule ( PANAS ) . Assessment s were done at baseline and after 6 weeks of radiotherapy treatment . RESULTS An intention to treat GLM repeated measures ANOVA showed significant difference across groups over time for positive affect , negative affect and emotional function and social function . There was significant improvement in positive affect ( ES = 0.59 , p = 0.007 , 95%CI 1.25 to 7.8 ) , emotional function ( ES = 0.71 , p = 0.001 , 95%CI 6.45 to 25.33 ) and cognitive function ( ES = 0.48 , p = 0.03 , 95%CI 1.2 to 18.5 ) , and decrease in negative affect ( ES = 0.84 , p<0.001 , 95%CI -13.4 to -4.4 ) in the yoga group as compared to controls . There was a significant positive correlation between positive affect with role function , social function and global quality of life . There was a significant negative correlation between negative affect with physical function , role function , emotional function and social function . CONCLUSION The results suggest a possible role for yoga to improve quality of life and affect in breast cancer out patients BACKGROUND Exercise has been reported to decrease cancer-related fatigue  and to increase quality of life ( QoL ) in various breast cancer ( BC ) population s. However , studies investigating exercise during radiotherapy or resistance training are scarce . We conducted a r and omized , controlled trial ( BEST study ) to assess the efficacy of 12-week resistance training on fatigue beyond possible psychosocial effects of a group-based intervention . PATIENTS AND METHODS One hundred sixty patients with BC stage 0-III were r and omly assigned to a 12-week progressive resistance training ( 2 times/week ) or a 12-week relaxation control ( RC , 2 times/week ) . Both interventions were group-based . The primary end point fatigue was assessed with a 20-item multidimensional question naire , QoL with EORTC question naires . Statistical analyses were based on analysis of covariance models for the individual changes from baseline to week 13 . RESULTS Adherence to the intervention program as well as the completion rate ( 97 % ) for the primary outcome variable fatigue was high . In intention-to-treat analyses for the N = 155 patients , significant between-group mean differences ( MD ) favoring the exercise group ( EX ) were observed for general fatigue ( P = 0.044 ) , especially for the subscale physical fatigue [ MD = -0.8 ; 95 % confidence interval -1.5 to -0.2 , P = 0.013 ] , but not for affective ( P = 0.91 ) or cognitive fatigue ( P = 0.65 ) . For QoL , significantly larger improvements regarding the role function ( P = 0.035 ) and pain ( P = 0.040 ) were noted among exercisers compared with RCs . Future perspective improved significantly stronger in the RC group compared with the EX group ( P = 0.047 ) . CONCLUSIONS The 12-week resistance training program was a safe , feasible and efficacious strategy to improve cancer-related fatigue and components of QoL  in BC patients during adjuvant radiotherapy . As exercise was compared with another group-based intervention , results indicate that resistance training effects on fatigue and QoL go beyond psychosocial benefits , and that the clinical ly relevant overall benefit of resistance exercise compared with usual care can be assumed to be higher . TRIAL REGISTRATION Clinical Trials.gov NCT01468766 BACKGROUND If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node , axillary lymph node dissection is the present st and ard . Although axillary lymph node dissection provides excellent regional control , it is associated with harmful side-effects . We aim ed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects . METHODS Patients with T1 - 2 primary breast cancer and no palpable lymphadenopathy were enrolled in the r and omised , multicentre , open-label , phase 3 non-inferiority EORTC 10981 - 22023 AMAROS trial . Patients were r and omly assigned ( 1:1 ) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node , stratified by institution . The primary endpoint was non-inferiority of 5-year axillary recurrence , considered to be not more than 4 % for the axillary radiotherapy group compared with an expected 2 % in the axillary lymph node dissection group . Analyses were by intention to treat and per protocol . The AMAROS trial is registered with Clinical Trials.gov , number NCT00014612 . FINDINGS Between Feb 19 , 2001 , and April 29 , 2010 , 4823 patients were enrolled at 34 centres from nine European countries , of whom 4806 were 
    Output:
    
In conclusion , HRQOL has been infrequently investigated in trials in BCP who received RT .