***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: Abstract Objective To evaluate a training intervention aim ed at improving healthcare professionals ' communication with cancer patients about r and omised clinical trials . Design Before and after evaluation of training programme . Setting Members of the National Cancer Research Network , Scottish Trials Network , and the Welsh Cancer Trials Network Participants 101 healthcare professionals ( 33 clinicians and 68 research nurses ) . Intervention Four modules delivered by a trained facilitator using videotapes and interactive exercises to cover general issues about discussing r and omised clinical trials with patients , problems specific to adjuvant trials , trials with palliation as the goal , and trials where patients had a strong preference for one treatment arm . Main outcome measures Before and after the intervention , participants were videotaped discussing a trial with an actor portraying a patient . These consultations were assessed for presence of information required by good clinical practice guidelines . The actor patients gave an assessment after each interview . Participants reported their self confidence about key aspects of trial discussion . Results Analysis of the videotaped consultations showed that , after intervention , significantly more participants displayed key communication behaviours such as explaining r and omisation ( 69 v 81 , odds ratio 2.33 , P = 0.033 ) , checking patients ' underst and ing ( 11 v 31 , odds ratio 3.22 , P = 0.002 ) , and discussing st and ard treatment ( 73 v 88 , odds ratio 4.75 , P = 0.005 ) and side effects ( 69 v 85 , odds ratio 3.29 , P = 0.006 ) . Participants ' self confidence increased significantly ( P < 0.001 ) across all areas . Actor patients ' ratings of participants ' communication showed significant improvements for 12/15 key items . Conclusion This intensive 8 hour intervention significantly improved participants ' confidence and competence when communicating about r and omised clinical trials BACKGROUND Children Cancer Group ( CCG ) 1991 is the first childhood acute lymphoblastic leukemia trial within CCG that allowed the utilization of a staged approach to the consent process . METHODS One hundred and forty subjects participated in the Project on Informed Consent  which compared the primary outcome measures in the consent process of patients enrolled in CCG-1991 with those enrolled in other CCG leukemia studies . RESULTS The parents ' trust scores were higher for the CCG-1991 compared with other protocol s. Eighty percent of parents enrolled in CCG-1991 understood the distinction between the r and omized clinical trial and the st and ard treatment arm , compared with 62.5 % in the other studies , P = 0.05 . Multiple other outcome measures suggested a positive impact from staged informed consent . CONCLUSIONS Our results suggest that a consent process with a staged approach can help investigators obtain a more truly informed consent . Future research is needed to confirm the benefits of the staged approach to the informed consent process PURPOSE Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population . This study hypothesized that use of an easy-to-read consent statement , when compared with a st and ard consent statement , will result in higher patient comprehension of the clinical treatment protocol , lower patient anxiety , higher patient satisfaction , and higher patient accrual . METHODS A r and omized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups . Institutions were r and omly assigned to administer either an easy-to-read consent statement or the st and ard consent statement to patients being recruited to participate in selected cancer treatment trials .  Telephone interviews were conducted with a total of 207 patients to assess study outcomes . RESULTS Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm . Patient comprehension and state anxiety were not affected by the intervention . Accrual rates into the parent studies also did not differ significantly between the two study groups . CONCLUSION Clinical trial informed consent statements can be modified to be easier to read without omitting critical information . Patient anxiety and satisfaction can be affected by the consent document . The generalizability of these study results is limited by the characteristics of the patient sample . Ninety percent of the sample were white women , and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64 , indicating a literacy level at or above the ninth grade We aim ed to study trends in the design and conduct of r and omised controlled trials ( RCTs ) in cancer in the UK , using the UK Coordinating Committee for Cancer Research ( UKCCCR ) National Register of Cancer Trials ( N RCT ) . We conducted a descriptive survey of 520 UK RCTs in cancer that were registered on the UKCCCR N RCT . All trials had been initiated between 1971 and 2000 . Trials on the N RCT have been conducted in a wide variety of cancer types , but with a third in breast ( 22 % ) or lung cancer ( 11 % ) . They have largely been funded by the UK public and charity sectors . Overall , there has been a sustained rise in the total numbers of patients entering UK cancer trials over time with a trend towards larger , multicentre trials , greater recruitment targets and a marked reduction in the average time taken to complete trials . Trends in the design and conduct of noncommercial cancer RCTs from 1971 to 2000 are encouraging . It will be interesting to see how they develop in light of the implementation of recent national initiatives regarding cancer clinical trials in the UK Methods of obtaining informed consent have evolved differently in Western countries without substantive information on the impact of these different practice s on the patients . A r and omised study was performed to compare two commonly adopted methods of seeking consent to r and omised treatment : an individual approach at the discretion of each doctor and a uniform policy of total disclosure of all relevant information . The impact of both consent procedures on the patient 's underst and ing and anxiety levels and on the doctor-patient relationship was assessed by means of a question naire given soon after the consent interview . Fifty seven patients were assigned at r and om to two groups : to 29 patients an individual approach to seeking consent was adopted and to 28 patients all relevant information was given . Seven patients refused consent to r and omised treatment , with slightly more refusals by patients in the total disclosure group ( 5 v 2 , p = 0.25 ) . The main effects of total disclosure of all information compared with an individual approach to seeking consent were : a better underst and ing of treatment and side effects and of research aspects of the treatments ; less willingness to agree to r and omised treatment ; and increased anxiety . No significant differences were found in patients ' perceptions of the doctor-patient relationship . A repeat question naire given three to four weeks later no longer showed significant differences between the two groups Evaluating the impact of written material s is a means to enhance the effectiveness of patient education , yet few controlled studies of publications have been completed . In 1984 , as a result of a needs assessment , the National Cancer Institute ( NCI ) developed and pretested the booklet " What Are Clinical Trials All About ? " The booklet was design ed to help cancer patients make informed decisions about participation in clinical trials , which are critical for improving cancer treatment . The booklet , which is currently available , has been used internationally as a model for communicating information on clinical trials . Since 1985 , the booklet has been used by the Cancer Information Service ( CIS ) as an educational tool for answering questions from cancer patients about treatment and clinical trials . The CIS , which has traditionally assisted NCI in the development and testing of educational material s , was involved in the pretesting and particularly the posttesting of this booklet . The CIS regional offices at Fox Chase Cancer Center and Sylvester Comprehensive Cancer Center together with National Institutes of Health Clinical Center and North Memorial Medical Center conducted a posttest evaluation of the booklet 's effectiveness for cancer patients . Two hospitals tested the booklet on patients who were eligible for a specific clinical trial , and two hospitals tested the booklet on patients who were theoretically eligible for a clinical trial ( with a cancer site and stage for which a trial existed ) . Patients were r and omly assigned : 203 experimental subjects received the booklet  , and 194 control subjects were not given the booklet until after a 2-week posttest examining attitudes , knowledge , and beliefs about clinical trials . ( ABSTRACT TRUNCATED AT 250 WORDS We report results from an intervention study to improve communication during consultations about r and omised clinical trials of cancer therapy .  Patients , eligible for a trial , completed question naires about information preferences and attitudes to trials prior to seeing their doctors , who were either shown these question naires ( intervention ) or not ( control ) . Fifteen doctors participated and invited 265 patients to join one of 40 different r and omised clinical trials . Most patients ( 77.4 % ) agreed to trial entry and this was predicted by the Patient 's Attitudes to Trials question naire with an 80.4 % accuracy . Accrual , length of consultation , doctor and patient satisfaction were not associated with the intervention . Further research to explore the potential use of written interventions to facilitate communication and accrual to r and omised clinical trials is recommended 8040 Background : Older persons ( age 65 and older ) are underrepresented in cancer clinical trials . CALGB 9670 ( JCO 21:2268,2003 ) found that older women with breast cancer were as likely as younger women to participate in a clinical trial if offered but trials were offered to them less often . 42 % of physicians stated that greater education about cancer treatment in older persons would improve accrual . Thus , we design ed a r and omized phase III trial of an educational program . METHODS Main member institutions and their affiliates with a mean accrual to treatment protocol s of 5 or more patients per year over 3 years were r and omized by main member institution to either : ( 1 ) st and ard information ( n=72 ) or ( 2 ) educational intervention ( n=53 ) . St and ard information included CALGB website access and periodic notification about existing CALGB trials . The geriatric educational intervention included st and ard information plus : 1 ) an educational seminar ; 2 ) educational material s ; 3 ) protocol checklists for use on charts ; 4 ) monthly email and mail reminders for one year ; and 5 ) a case discussion seminar . The main outcome was percent accrual of older persons to phase II and III treatment protocol s during the 1st and 2nd years after study initiation compared to baseline accrual . RESULTS There were 6431 accruals during the study : 3032 , 2160 , and 1239 during baseline , year 1 and year 2 , respectively . Percent accrual of older persons during the study is presented in the table . CONCLUSIONS Decline in accrual is likely related to closure of several large accruing trials during the study . Lack of effect of the intervention may have been related to low intensity of the intervention . More intense and /or more far-reaching intervention is needed to improve accrual of older persons to clinical trials . Supported by CALGB ( CA31946 ) . [ Figure : see text ] [ Table : see text ] PURPOSE Here we report the results of a r and omized study undertaken to test the efficacy of a supplementary , telephone-based nursing intervention in increasing patients ' awareness and underst and ing of the clinical trials in which they are asked to participate . METHODS During a 12-month period , 180 cancer patients who were approached to participate in a phase II or III clinical trial were r and omized to undergo either of the following : ( 1 ) st and ard informed consent procedures based on verbal explanations from the treating physician plus written information ( controls ) ; or ( 2 ) st and ard informed consent procedures plus a supplementary , telephone-based contact with an oncology nurse ( intervention ) . For purpose s of evaluation , face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed . RESULTS The two groups were comparable with regard to sociodemographic and clinical variables . Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments . The intervention group was significantly ( P < .01 ) better informed about the following : ( 1 ) the risks and side effects of treatment ; ( 2 ) the clinical trial context of the treatment ; ( 3 ) the objectives of the clinical trial ; ( 4 ) where relevant , the use of r and omization in allocating treatment ; ( 5 ) the availability of alternative treatments ; ( 6 ) the voluntary nature of participation ; and ( 7 ) the right to withdraw from the clinical trial . The intervention did not have any significant effect on patients ' anxiety levels or on rates of clinical trial participation . Patients reported high levels of satisfaction with the intervention . CONCLUSION The use of a supplementary , telephone-based nursing intervention is a feasible and effective means to increase cancer patients ' awareness and underst and ing of the salient issues that surround the clinical trials in which they are asked to participate BACKGROUND This study examined the outcomes of providing a copy of the PDQ Patient Information File ( PIF ) to cancer patients . METHODS Patients with cervical , endometrial , and ovarian cancers were r and omized to two groups : 1 ) verbal communication only and 2 ) verbal communication plus PIF . Cancer knowledge and satisfaction with the PIF and the information received were assessed with telephone interviews . Clinical trial registries were review ed to determine enrollment in clinical trials . RESULTS The overall reaction to the PIF was good or excellent for 92 % of the patients surveyed , but there was no significant difference between the two groups in their cancer knowledge , enrollment in clinical trials , or satisfaction with the information they received from their physicians . The majority of patients from both groups lacked basic knowledge about their disease , did not use any source of information other than their physicians and /or nurses , and were satisfied with the information they received . CONCLUSIONS Patients appreciate receiving written cancer information , although it may not increase their cancer knowledge PURPOSE Clinical trials 
    Output:
    
There was no robust evidence that any of the interventions investigated led to an increase in  cancer patient participation in RCTs , though one good quality RCT found that urologists and nurses were equally effective at recruiting participants to a treatment trial for prostate cancer .
Although there was no evidence of an effect in any of the studies , the evidence was not of sufficient quality to be able to conclude that these interventions therefore do not work .
Conclusion There is not a strong evidence -base for interventions that increase  cancer patient participation  in r and omised trials .