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: In a r and omized controlled design , this study tested the efficacy of a theoretically based uncertainty management intervention delivered to older long-term breast cancer survivors . The sample included 509 recurrence-free women ( 360 Caucasian , 149 African-American women ) with a mean age of 64 years ( S.D.=8.9 years ) who were 5 - 9 years post-treated for breast cancer . Women were r and omly assigned to either the intervention or usual care control condition . The intervention was delivered during four weekly telephone sessions , in which study nurses guided cancer survivors in the use of audiotaped cognitive-behavioral strategies to manage uncertainty about recurrence , and a self-help manual design ed to help women underst and and manage long-term treatment side effects and other symptoms . Treatment outcome data on uncertainty management were gathered at pre-intervention and 10-months afterward . Repeated measures MANOVA evaluating treatment group , ethnic group , and treatment by ethnic interaction effects indicated that training in uncertainty management result ed in improvements in cognitive reframing , cancer knowledge , patient-health care provider communication , and a variety of coping skills . Results are discussed in terms of the importance of theory-based interventions for cancer survivors that target triggers of uncertainty about recurrence and in terms of ethnic differences in response to the intervention Background : Patient navigation is a promising intervention to ameliorate cancer health disparities . This study objective was to measure patient navigation effects on cancer-specific quality of life ( QOL ) among patients with newly diagnosed cancer . Methods : A r and omized controlled trial of patient navigation was conducted in Rochester , NY . Patients with breast cancer and colorectal cancer were r and omly assigned to receive a patient navigation intervention or usual care .  QOL was measured at baseline and four subsequent time points , using the vali date d Functional Assessment of Cancer Therapy ( FACT-B , FACT-C ) instruments . Results : Among 319 r and omized patients ( 165 patient navigation , 154 control ) , median age was 57 years and 32.5 % were from minority race/ethnicity groups .  Patient navigation and control groups were comparable on baseline factors , except home ownership versus renting ( more home ownership among controls , P = 0.05 ) and race ( more whites among controls , P = 0.05 ) . Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months , or at various time points . The emotional well-being subscale change from baseline approached significance ( better change among patient navigation group , P = 0.05 ) . Time trends of QOL measures did not differ significantly between groups . Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL . Conclusions : In this r and omized trial of patient navigation , there was no statistically significant effect on disease-specific QOL . Impact : These results suggest that patient navigation may not affect QOL during cancer treatment , that social/medical support are adequate in this study 's setting , or that the trial failed to target patients likely to experience QOL benefit from patient navigation . Cancer Epidemiol Biomarkers Prev ; 21(10 ) ; 1682–90 . © 2012 AACR Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials UNLABELLED Studies of comprehensive geriatric assessment ( CGA ) have shown the importance of follow-up for effectiveness , but this has not been tested in an oncology clinic . In this pilot study , we enrolled 15 early breast cancer patients , aged 70 and older . They received a multidisciplinary CGA every 3 months and structured follow-up from the SAOP nurse practitioner , dietitian , social worker , and pharmacist according to risk . Total follow-up was 6 months . Median age of evaluable patients was 79 years ( range 72 - 87 ) .  Median number of comorbidities by Cumulative Index Rating Scale-Geriatric ( CIRS-G ) was 5 ( 3 - 9 ) at baseline . Ten patients were at pharmacological risk , five at psychosocial risk , and eight at nutritional risk . Patients presented on average six problems initially , and three new problems during follow-up . The intervention directly influenced oncological treatment in four cases . It ensured continuity/coordination of care in seven cases . Success rate in addressing problems was 87 % . Mean Functional Assessment of Cancer Treatment-Breast ( FACT-B ) scores improved from 110.5 ( S.D. 16.7 ) to 116.3 ( S.D. 16.5 ) ( t=0.025 ) . Function and independence were maintained . CONCLUSIONS Older patients with early breast cancer have a high prevalence of comorbidity . A CGA with follow-up has potential for improving the treatment and prognosis of these patients and is feasible in an academic oncology setting OBJECTIVES The Patient Activation Measure ( PAM ) quantifies the extent to which people are informed about and involved in their health care . Objectives were to determine the psychometric properties of PAM among multimorbid older adults and evaluate a theoretical , four-stage model of patient activation . Methods . A cross-sectional analysis was used to assess the psychometric properties of PAM . Internal consistency was assessed using Cronbach α . Construct validity was evaluated using general linear modeling to compute associations between PAM scores and health-related behaviors , functional status , and health care quality . Latent class analysis was used to evaluate the theoretical four-stage structure of patient activation . STUDY SETTING Participants in a r and omized trial of Guided Care ( N = 855 ) , a model of comprehensive health care for older adults with chronic conditions that put them at risk of using health services heavily during the coming year . PRINCIPAL FINDINGS Higher PAM activation scores and stage were positively associated with higher functional status , health care quality , and adherence to some health behaviors . Latent class analysis supported the multistage theory of patient activation . CONCLUSIONS The PAM is a reliable , valid , and potentially clinical ly useful measure of patient activation for multimorbid older adults We examined the feasibility of a Cancer Care Dialogues Model , with daily telehealth interactions between patients at home and their care coordinator , who acted as an adjunct to the oncologist . The patient and the care coordinator used a home messaging device , connected via the ordinary telephone network . Thirty-four patients with a new diagnosis of cancer and whose treatment plan included chemotherapy taken at a single clinic were enrolled and followed for six months . The home messaging device collected information daily on common symptoms associated with chemotherapy . On average , the patients had the home messaging device for 120 days ( range 30–180 ) . The mean cooperation rate was 84 % ( range 4–100 ) . No variables were significantly associated with patient cooperation in the dialogues over time . The health-related quality of life ( HRQL ) mean score at baseline was 73.9 ( SD 15.4 ) , and the mean score at six months was 78.4 ( SD 14.5 ) . After adjusting for demographic and clinical factors , there was a 6.5-point increase in HRQL score between the baseline and end of treatment , which represented an important clinical difference . Management of nervousness/worry over time through cancer care dialogues is important in maintaining HRQL and can be assisted by remote home messaging OBJECTIVES To evaluate the effect of nurse case management on the treatment of older women with breast cancer . DESIGN R and omized prospect i ve trial . SETTING Sixty surgeons practicing at 13 community and two public hospitals in southeast Texas . PARTICIPANTS Three hundred thirty-five women ( 166 control and 169 intervention ) aged 65 and older newly diagnosed with breast cancer . INTERVENTION Women seeing surgeons r and omized to the intervention group received the services of a nurse case manager for 12 months after the diagnosis of breast cancer . MEASUREMENTS The primary outcome was the type and use of cancer-specific therapies received in the first 6 months after diagnosis . Secondary outcomes were patient satisfaction and arm function on the affected side 2 months after diagnosis . RESULTS More women in the intervention group received  breast-conserving surgery  ( 28.6 % vs 18.7 % ; P=.031 ) and  radiation therapy  ( 36.0 % vs 19.0 % ; P=.003 ) . Of women undergoing breast-conserving surgery , greater percentages in the case management group received  adjuvant radiation  ( 78.3 % vs 44.8 % ; P=.001 ) and axillary dissection ( 71.4 % vs 44.8 % ; P=.057 ) . Women in the case management group were also more likely to receive more breast reconstruction surgery ( 9.3 % vs 2.6 % , P=.054 ) , and women in the case management group with advanced cancer were more likely to receive chemotherapy ( 72.7 % vs 30.0 % , P=.057 ) . Two months after surgery , higher percentages of women in the case manager group had normal arm function ( 93 % vs 84 % ; P=.037 ) and were more likely to state that they had a real choice in their treatment ( 82.2 % vs 69.9 % , P=.020 ) . Women with indicators of poor social support were more likely to benefit from nurse case management .  CONCLUSION Nurse case management results in more appropriate management of older women with breast cancer CONTEXT Changes in the healthcare system have result ed in shortened hospital stays , moving the focus of care from the hospital to the home . Patients are discharged post-operatively with ongoing needs , and whether they receive nursing care post-hospitalization can influence their recovery and survival . Little information is available about the factors that influence outcomes , including the survival of older cancer patients after cancer surgery . OBJECTIVE To compare the length of survival of older post-surgical cancer patients who received a specialized home care intervention provided by advanced practice nurses ( APNs ) with that of patients who received usual follow-up care in an ambulatory setting .  We also assessed potential predictors of survival in terms of depressive symptoms , symptom distress , functional status , comorbidities , length of hospital stay , age of patient , and stage of disease . DESIGN A r and omized controlled intervention study . SETTING Discharged older cancer patients after surgery at a Comprehensive Cancer Center in southeastern Pennsylvania . PATIENTS Three hundred seventy-five patients aged 60 to 92 , newly diagnosed with solid cancers , were treated surgically between February 1993 and December 1995 . One hundred ninety patients were r and omized to the intervention groups and 185 to the usual care group .  INTERVENTION The intervention was a st and ardized protocol that consisted of st and ard assessment and management post-surgical guidelines , doses of instructional content , and schedules of contacts . The intervention lasted 4 weeks and consisted of three home visits and five telephone contacts provided by APNs . Both the patients and their family caregivers received comprehensive clinical assessment s , monitoring , and teaching , including skills training . MAIN OUTCOME MEASURE Time from enrollment of patients into the study until death or last date known alive at the end of November 1996 . RESULTS During the 44-month follow-up period , 93 ( 24.8 % ) of 375 patients died . Forty-one ( 22 % ) of those who died were patients in the specialized home care intervention group , compared with 52 ( 28 % ) in the usual care group . Stage of disease at diagnosis differed between the two groups at baseline ( 38 % late stage patients in the intervention group compared with 26 % in the control group , P = .01 ) , so stratified analysis was performed . Overall , the specialized home care intervention group was found to have increased survival ( P = .002 using stratified log-rank test ) . Among early stage patients only , there was no difference in survival between the intervention and control groups . Among late stage patients , there was improved survival in the 
    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: In a r and omized controlled design , this study tested the efficacy of a theoretically based uncertainty management intervention delivered to older long-term breast cancer survivors . The sample included 509 recurrence-free women ( 360 Caucasian , 149 African-American women ) with a mean age of 64 years ( S.D.=8.9 years ) who were 5 - 9 years post-treated for breast cancer . Women were r and omly assigned to either the intervention or usual care control condition . The intervention was delivered during four weekly telephone sessions , in which study nurses guided cancer survivors in the use of audiotaped cognitive-behavioral strategies to manage uncertainty about recurrence , and a self-help manual design ed to help women underst and and manage long-term treatment side effects and other symptoms . Treatment outcome data on uncertainty management were gathered at pre-intervention and 10-months afterward . Repeated measures MANOVA evaluating treatment group , ethnic group , and treatment by ethnic interaction effects indicated that training in uncertainty management result ed in improvements in cognitive reframing , cancer knowledge , patient-health care provider communication , and a variety of coping skills . Results are discussed in terms of the importance of theory-based interventions for cancer survivors that target triggers of uncertainty about recurrence and in terms of ethnic differences in response to the intervention Background : Patient navigation is a promising intervention to ameliorate cancer health disparities . This study objective was to measure patient navigation effects on cancer-specific quality of life ( QOL ) among patients with newly diagnosed cancer . Methods : A r and omized controlled trial of patient navigation was conducted in Rochester , NY . Patients with breast cancer and colorectal cancer were r and omly assigned to receive a patient navigation intervention or usual care .  QOL was measured at baseline and four subsequent time points , using the vali date d Functional Assessment of Cancer Therapy ( FACT-B , FACT-C ) instruments . Results : Among 319 r and omized patients ( 165 patient navigation , 154 control ) , median age was 57 years and 32.5 % were from minority race/ethnicity groups .  Patient navigation and control groups were comparable on baseline factors , except home ownership versus renting ( more home ownership among controls , P = 0.05 ) and race ( more whites among controls , P = 0.05 ) . Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months , or at various time points . The emotional well-being subscale change from baseline approached significance ( better change among patient navigation group , P = 0.05 ) . Time trends of QOL measures did not differ significantly between groups . Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL . Conclusions : In this r and omized trial of patient navigation , there was no statistically significant effect on disease-specific QOL . Impact : These results suggest that patient navigation may not affect QOL during cancer treatment , that social/medical support are adequate in this study 's setting , or that the trial failed to target patients likely to experience QOL benefit from patient navigation . Cancer Epidemiol Biomarkers Prev ; 21(10 ) ; 1682–90 . © 2012 AACR Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials UNLABELLED Studies of comprehensive geriatric assessment ( CGA ) have shown the importance of follow-up for effectiveness , but this has not been tested in an oncology clinic . In this pilot study , we enrolled 15 early breast cancer patients , aged 70 and older . They received a multidisciplinary CGA every 3 months and structured follow-up from the SAOP nurse practitioner , dietitian , social worker , and pharmacist according to risk . Total follow-up was 6 months . Median age of evaluable patients was 79 years ( range 72 - 87 ) .  Median number of comorbidities by Cumulative Index Rating Scale-Geriatric ( CIRS-G ) was 5 ( 3 - 9 ) at baseline . Ten patients were at pharmacological risk , five at psychosocial risk , and eight at nutritional risk . Patients presented on average six problems initially , and three new problems during follow-up . The intervention directly influenced oncological treatment in four cases . It ensured continuity/coordination of care in seven cases . Success rate in addressing problems was 87 % . Mean Functional Assessment of Cancer Treatment-Breast ( FACT-B ) scores improved from 110.5 ( S.D. 16.7 ) to 116.3 ( S.D. 16.5 ) ( t=0.025 ) . Function and independence were maintained . CONCLUSIONS Older patients with early breast cancer have a high prevalence of comorbidity . A CGA with follow-up has potential for improving the treatment and prognosis of these patients and is feasible in an academic oncology setting OBJECTIVES The Patient Activation Measure ( PAM ) quantifies the extent to which people are informed about and involved in their health care . Objectives were to determine the psychometric properties of PAM among multimorbid older adults and evaluate a theoretical , four-stage model of patient activation . Methods . A cross-sectional analysis was used to assess the psychometric properties of PAM . Internal consistency was assessed using Cronbach α . Construct validity was evaluated using general linear modeling to compute associations between PAM scores and health-related behaviors , functional status , and health care quality . Latent class analysis was used to evaluate the theoretical four-stage structure of patient activation . STUDY SETTING Participants in a r and omized trial of Guided Care ( N = 855 ) , a model of comprehensive health care for older adults with chronic conditions that put them at risk of using health services heavily during the coming year . PRINCIPAL FINDINGS Higher PAM activation scores and stage were positively associated with higher functional status , health care quality , and adherence to some health behaviors . Latent class analysis supported the multistage theory of patient activation . CONCLUSIONS The PAM is a reliable , valid , and potentially clinical ly useful measure of patient activation for multimorbid older adults We examined the feasibility of a Cancer Care Dialogues Model , with daily telehealth interactions between patients at home and their care coordinator , who acted as an adjunct to the oncologist . The patient and the care coordinator used a home messaging device , connected via the ordinary telephone network . Thirty-four patients with a new diagnosis of cancer and whose treatment plan included chemotherapy taken at a single clinic were enrolled and followed for six months . The home messaging device collected information daily on common symptoms associated with chemotherapy . On average , the patients had the home messaging device for 120 days ( range 30–180 ) . The mean cooperation rate was 84 % ( range 4–100 ) . No variables were significantly associated with patient cooperation in the dialogues over time . The health-related quality of life ( HRQL ) mean score at baseline was 73.9 ( SD 15.4 ) , and the mean score at six months was 78.4 ( SD 14.5 ) . After adjusting for demographic and clinical factors , there was a 6.5-point increase in HRQL score between the baseline and end of treatment , which represented an important clinical difference . Management of nervousness/worry over time through cancer care dialogues is important in maintaining HRQL and can be assisted by remote home messaging OBJECTIVES To evaluate the effect of nurse case management on the treatment of older women with breast cancer . DESIGN R and omized prospect i ve trial . SETTING Sixty surgeons practicing at 13 community and two public hospitals in southeast Texas . PARTICIPANTS Three hundred thirty-five women ( 166 control and 169 intervention ) aged 65 and older newly diagnosed with breast cancer . INTERVENTION Women seeing surgeons r and omized to the intervention group received the services of a nurse case manager for 12 months after the diagnosis of breast cancer . MEASUREMENTS The primary outcome was the type and use of cancer-specific therapies received in the first 6 months after diagnosis . Secondary outcomes were patient satisfaction and arm function on the affected side 2 months after diagnosis . RESULTS More women in the intervention group received  breast-conserving surgery  ( 28.6 % vs 18.7 % ; P=.031 ) and  radiation therapy  ( 36.0 % vs 19.0 % ; P=.003 ) . Of women undergoing breast-conserving surgery , greater percentages in the case management group received  adjuvant radiation  ( 78.3 % vs 44.8 % ; P=.001 ) and axillary dissection ( 71.4 % vs 44.8 % ; P=.057 ) . Women in the case management group were also more likely to receive more breast reconstruction surgery ( 9.3 % vs 2.6 % , P=.054 ) , and women in the case management group with advanced cancer were more likely to receive chemotherapy ( 72.7 % vs 30.0 % , P=.057 ) . Two months after surgery , higher percentages of women in the case manager group had normal arm function ( 93 % vs 84 % ; P=.037 ) and were more likely to state that they had a real choice in their treatment ( 82.2 % vs 69.9 % , P=.020 ) . Women with indicators of poor social support were more likely to benefit from nurse case management .  CONCLUSION Nurse case management results in more appropriate management of older women with breast cancer CONTEXT Changes in the healthcare system have result ed in shortened hospital stays , moving the focus of care from the hospital to the home . Patients are discharged post-operatively with ongoing needs , and whether they receive nursing care post-hospitalization can influence their recovery and survival . Little information is available about the factors that influence outcomes , including the survival of older cancer patients after cancer surgery . OBJECTIVE To compare the length of survival of older post-surgical cancer patients who received a specialized home care intervention provided by advanced practice nurses ( APNs ) with that of patients who received usual follow-up care in an ambulatory setting .  We also assessed potential predictors of survival in terms of depressive symptoms , symptom distress , functional status , comorbidities , length of hospital stay , age of patient , and stage of disease . DESIGN A r and omized controlled intervention study . SETTING Discharged older cancer patients after surgery at a Comprehensive Cancer Center in southeastern Pennsylvania . PATIENTS Three hundred seventy-five patients aged 60 to 92 , newly diagnosed with solid cancers , were treated surgically between February 1993 and December 1995 . One hundred ninety patients were r and omized to the intervention groups and 185 to the usual care group .  INTERVENTION The intervention was a st and ardized protocol that consisted of st and ard assessment and management post-surgical guidelines , doses of instructional content , and schedules of contacts . The intervention lasted 4 weeks and consisted of three home visits and five telephone contacts provided by APNs . Both the patients and their family caregivers received comprehensive clinical assessment s , monitoring , and teaching , including skills training . MAIN OUTCOME MEASURE Time from enrollment of patients into the study until death or last date known alive at the end of November 1996 . RESULTS During the 44-month follow-up period , 93 ( 24.8 % ) of 375 patients died . Forty-one ( 22 % ) of those who died were patients in the specialized home care intervention group , compared with 52 ( 28 % ) in the usual care group . Stage of disease at diagnosis differed between the two groups at baseline ( 38 % late stage patients in the intervention group compared with 26 % in the control group , P = .01 ) , so stratified analysis was performed . Overall , the specialized home care intervention group was found to have increased survival ( P = .002 using stratified log-rank test ) . Among early stage patients only , there was no difference in survival between the intervention and control groups . Among late stage patients , there was improved survival in the 
    Output:
    