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 : Despite thous and s of papers , the value of quality of life ( QoL ) in curing disease remains uncertain . Until now , we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building , modelling , an exploratory trial and now a definitive r and omised controlled trial ( RCT ) in breast cancer , whose results we report here . Methods : In all , 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals . Patients were r and omised to either ( 1 ) a novel care pathway including diagnosis of ‘ diseased ’ QoL ( any QoL measure below 50 points ) using a QoL profile and expert report sent to the patient 's coordinating practitioner , who arranged QoL therapy consisting of up to five st and ardised treatments for specific QoL defects or ( 2 ) st and ard postoperative care adhering to the German national guideline for breast cancer . The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery . Patients were blinded to their allocated group . Results : At 0 and 3 months after surgery , diseased QoL was diagnosed in 70 % of patients . The QoL pathway reduced rates of diseased QoL to 56 % at 6 months , especially in emotion and coping , compared with 71 % in controls ( P=0.048 ) . Relative risk reduction was 21 % ( 95 % confidence interval ( CI ) : 0–37 ) , absolute risk reduction 15 % ( 95 % CI : 0.3–29 ) , number needed to treat (NNT)=7 ( 95 % CI : 3–37 ) . When QoL therapy finished after successful treatment , diseased QoL often returned again , indicating good responsiveness of the QoL pathway . Conclusion : A three-component outcome system including clinician-derived objective , patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention . A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based , pragmatic , definitive RCT . While the pathway was active , it was effective with an NNT of 7 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 Objectives : The internet offers new possibilities in psychosocial patient care . However , empirical data are lacking for oncological patients . A field-experimental study was conducted to obtain initial data to enable evaluation of the effectiveness of online counseling via e-mail for breast cancer patients . A secondary objective was to explore how patients reached by the service can be characterized on psychosocial status and illness . Methods : On a dedicated German- language website , 235 breast cancer patients registered for psychosocial counseling via e-mail . 133 registrants were r and omly assigned to a treatment group to receive immediate counseling or to a waiting list control group . The two-month counseling session took the form of a psychoeducation , individually tailored to each patient . Psychosocial outcome measures including psychological distress ( BSI ) and quality of life ( EORTC QLQ-C30 ) were assessed at registration and at a two-month follow-up . Descriptive data were recorded at registration . At the conclusion of the program , participants were asked to complete a patient satisfaction question naire ( ZUF-8 ) . Results : BSI responses showed that 85 % of all patients were initially diagnosable with comorbid psychopathology . Despite high severity of distress and attendant large reductions in quality of life , 72 % of all patients were not obtaining conventional assistance . Among counseling participants ( n=31 ) , no significant improvements in distress or quality of life were found in comparison to the control group ( n=34 ) , but patient satisfaction was nonetheless high . Conclusion : The study demonstrates that online counseling via e-mail reaches patients with unmet therapeutic needs , but also indicated its limitations , suggesting that the online setting may be most useful for prompting and supporting a transition to conventional counseling services PURPOSE To evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue .  PATIENTS AND METHODS This r and omized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers . Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart . Instruments included a numeric rating scale assessing confidence with managing fatigue ; 11-point numeric rating scales measuring fatigue at worst , average , and best ; the Functional Assessment of Cancer Therapy-Fatigue and Piper Fatigue Scales ; the Cancer Self-Efficacy Scale ; the European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 ; and the Hospital Anxiety and Depression Scale . For each outcome , separate analyses of covariance of change scores between baseline ( T1 ) and the three follow-up time points ( T2 , T3 , and T4 ) were conducted , controlling for the variable 's corresponding baseline value . RESULTS Compared with the intervention group , mean difference scores between the baseline ( T1 ) and immediate after the test ( T2 ) assessment s increased significantly more for the control group for worst and average fatigue , Functional Assessment of Cancer Therapy-Fatigue , and Piper fatigue severity and interference measures . These differences were not observed between baseline and T3 and T4 assessment s. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue , cancer self-efficacy , anxiety , depression , or quality of life . CONCLUSION Preparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term . However , further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue OBJECTIVE The aim is to evaluate the effectiveness of a manualized 12-week supportive-expressive group therapy program among primary breast cancer patients treated in community setting s , to determine whether highly distressed patients were most likely to benefit and whether therapist 's training or experience was related to outcome . METHOD Three hundred and fifty-three women within one year of diagnosis with primary breast cancer were r and omly assigned to receive supportive-expressive group therapy or to an education control condition . Participants were recruited from two academic centers and nine oncology practice s , which were members of NCI 's Community Clinical Oncology Program ( CCOP ) and were followed over 2 years . RESULTS A 2x2x19 analysis of variance was conducted with main effects of treatment condition , cohort , and baseline distress and their interactions . There was no main effect for treatment condition after removing one subject with an extreme score .  Highly distressed women did not derive a greater benefit from treatment . Therapist training and psychotherapy experience were not associated with a treatment effect . CONCLUSIONS This study provides no evidence of reduction in distress as the result of a brief supportive-expressive intervention for women with primary breast cancer . Future studies might productively focus on women with higher initial levels of distress The question of whether stress poses a risk for cancer progression has been difficult to answer . A r and omized clinical trial tested the hypothesis that cancer patients coping with their recent diagnosis but receiving a psychologic intervention  would have improved survival compared with patients who were only assessed OBJECTIVES Considerable morbidity persists among survivors of breast cancer ( BC ) including high levels of psychological stress , anxiety , depression , fear of recurrence , and physical symptoms including pain , fatigue , and sleep disturbances , and impaired quality of life . Effective interventions are needed during this difficult transitional period . METHODS We conducted a r and omized controlled trial of 84 female BC survivors ( Stages 0-III ) recruited from the H. Lee Moffitt Cancer and Research Institute . All subjects were within 18 months of treatment completion with surgery and adjuvant radiation and /or chemotherapy .  Subjects were r and omly assigned to a 6-week Mindfulness-Based Stress Reduction ( MBSR ) program design ed to self-regulate arousal to stressful circumstances or symptoms ( n=41 ) or to usual care ( n=43 ) . Outcome measures compared at 6 weeks by r and om assignment included vali date d measures of psychological status ( depression , anxiety , perceived stress , fear of recurrence , optimism , social support ) and psychological and physical subscales of quality of life ( SF-36 ) . RESULTS Compared with usual care , subjects assigned to MBSR(BC ) had significantly lower ( two-sided p<0.05 ) adjusted mean levels of depression ( 6.3 vs 9.6 ) , anxiety ( 28.3 vs 33.0 ) , and fear of recurrence ( 9.3 vs 11.6 ) at 6 weeks , along with higher energy ( 53.5 vs 49.2 ) , physical functioning ( 50.1 vs 47.0 ) , and physical role functioning ( 49.1 vs 42.8 ) . In stratified analyses , subjects more compliant with MBSR tended to experience greater improvements in measures of energy and physical functioning . CONCLUSIONS Among BC survivors within 18 months of treatment completion , a 6-week MBSR(BC ) program result ed in significant improvements in psychological status and quality of life compared with usual care The effects of 8-week cancer support groups ( CSGs ) with and without coaching on adaptation were tested in a sample of 181 women with newly diagnosed early stage breast cancer .  CSG participation with coaching result ed in higher quality of relationship with significant other at CSG conclusion ; this effect was not sustained 8 weeks later . CSG participation had no effect on symptom distress , emotional distress , or functional status . On average , symptom distress was low , emotional distress was moderate , and functional status was relatively high . Independent of CSGs , symptom distress decreased and functional status increased over time from entry into the study to 16 weeks later . Further research is needed to determine the optimal starting time and length for CSGs OBJECTIVE The current report provides the result of a Phase II clinical trial regarding the effectiveness and feasibility of problem-solving therapy for psychological distress experienced by Japanese early-stage breast cancer patients . METHODS Participants were 36 post-surgery Japanese breast cancer patients in a university hospital located in Osaka Prefecture , Japan . After screening for psychological distress using the Distress and Impact Thermometer and the Hospital Anxiety and Depression Scale , highly distressed patients were exposed to 5 weekly sessions of the problem-solving therapy program . RESULTS Nineteen patients completed the intervention and follow-up . There was a significant difference between the pre-intervention and the 3-month follow-up in the total Hospital Anxiety and Depression Scale score ( P = 0.02 ) , and the mean change score from the pre-intervention to the follow-up was 6.05 ( SD = 1.94 ) . The intervention had a large effect size ( d = 0.82 ) . There were also significant changes in worry , self-efficacy and quality of life measures . CONCLUSIONS The findings of our study suggest that the problem-solving therapy program has potential to be effective for alleviating psychological distress experienced by Japanese early-stage breast cancer patients . The true effectiveness of the program should be confirmed by a future r and omized control trial PURPOSE To test the effectiveness of a psycho-educational group intervention to improve psychological distress measured by POMS TMD , Quality of Life measured by European Organisation for Research and Treatment of Cancer ( EORTC ) , the core and breast cancer module , Mental Adjustment measured by MAC and marital relationship measured by BLRI in women with primary breast cancer conducted 10 weeks after surgery . A secondary outcome was 4-year survival . PATIENTS AND METHODS We r and omly assigned 210 patients with primary breast cancer to a control or an intervention group . Patients in the intervention group were offered two weekly 6-h sessions of psycho-education and eight weekly 2-h sessions of group psychotherapy . All participants were followed up for Quality of Life , coping ability and social relations 1 , 6 and 12 months after the intervention and on survival 4 years after surgical treatment . RESULTS No statistically significant effects of the intervention were found on any of the psychosocial question naire outcomes . There were not enough cases of death to analyse overall survival . The only statistically significant result was for patients who used anti depressive medication , for whom almost all measures improved over time , in both the control and intervention groups . CONCLUSION Psycho-education and group psychotherapy did not decrease psychological distress or increase Quality of Life , Mental Adjustment or improve marital relationship among patients with primary breast cancer A Roy adaptation model 
    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 : Despite thous and s of papers , the value of quality of life ( QoL ) in curing disease remains uncertain . Until now , we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building , modelling , an exploratory trial and now a definitive r and omised controlled trial ( RCT ) in breast cancer , whose results we report here . Methods : In all , 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals . Patients were r and omised to either ( 1 ) a novel care pathway including diagnosis of ‘ diseased ’ QoL ( any QoL measure below 50 points ) using a QoL profile and expert report sent to the patient 's coordinating practitioner , who arranged QoL therapy consisting of up to five st and ardised treatments for specific QoL defects or ( 2 ) st and ard postoperative care adhering to the German national guideline for breast cancer . The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery . Patients were blinded to their allocated group . Results : At 0 and 3 months after surgery , diseased QoL was diagnosed in 70 % of patients . The QoL pathway reduced rates of diseased QoL to 56 % at 6 months , especially in emotion and coping , compared with 71 % in controls ( P=0.048 ) . Relative risk reduction was 21 % ( 95 % confidence interval ( CI ) : 0–37 ) , absolute risk reduction 15 % ( 95 % CI : 0.3–29 ) , number needed to treat (NNT)=7 ( 95 % CI : 3–37 ) . When QoL therapy finished after successful treatment , diseased QoL often returned again , indicating good responsiveness of the QoL pathway . Conclusion : A three-component outcome system including clinician-derived objective , patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention . A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based , pragmatic , definitive RCT . While the pathway was active , it was effective with an NNT of 7 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 Objectives : The internet offers new possibilities in psychosocial patient care . However , empirical data are lacking for oncological patients . A field-experimental study was conducted to obtain initial data to enable evaluation of the effectiveness of online counseling via e-mail for breast cancer patients . A secondary objective was to explore how patients reached by the service can be characterized on psychosocial status and illness . Methods : On a dedicated German- language website , 235 breast cancer patients registered for psychosocial counseling via e-mail . 133 registrants were r and omly assigned to a treatment group to receive immediate counseling or to a waiting list control group . The two-month counseling session took the form of a psychoeducation , individually tailored to each patient . Psychosocial outcome measures including psychological distress ( BSI ) and quality of life ( EORTC QLQ-C30 ) were assessed at registration and at a two-month follow-up . Descriptive data were recorded at registration . At the conclusion of the program , participants were asked to complete a patient satisfaction question naire ( ZUF-8 ) . Results : BSI responses showed that 85 % of all patients were initially diagnosable with comorbid psychopathology . Despite high severity of distress and attendant large reductions in quality of life , 72 % of all patients were not obtaining conventional assistance . Among counseling participants ( n=31 ) , no significant improvements in distress or quality of life were found in comparison to the control group ( n=34 ) , but patient satisfaction was nonetheless high . Conclusion : The study demonstrates that online counseling via e-mail reaches patients with unmet therapeutic needs , but also indicated its limitations , suggesting that the online setting may be most useful for prompting and supporting a transition to conventional counseling services PURPOSE To evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue .  PATIENTS AND METHODS This r and omized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers . Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart . Instruments included a numeric rating scale assessing confidence with managing fatigue ; 11-point numeric rating scales measuring fatigue at worst , average , and best ; the Functional Assessment of Cancer Therapy-Fatigue and Piper Fatigue Scales ; the Cancer Self-Efficacy Scale ; the European Organisation for Research and Treatment of Cancer Quality of Life Question naire C30 ; and the Hospital Anxiety and Depression Scale . For each outcome , separate analyses of covariance of change scores between baseline ( T1 ) and the three follow-up time points ( T2 , T3 , and T4 ) were conducted , controlling for the variable 's corresponding baseline value . RESULTS Compared with the intervention group , mean difference scores between the baseline ( T1 ) and immediate after the test ( T2 ) assessment s increased significantly more for the control group for worst and average fatigue , Functional Assessment of Cancer Therapy-Fatigue , and Piper fatigue severity and interference measures . These differences were not observed between baseline and T3 and T4 assessment s. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue , cancer self-efficacy , anxiety , depression , or quality of life . CONCLUSION Preparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term . However , further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue OBJECTIVE The aim is to evaluate the effectiveness of a manualized 12-week supportive-expressive group therapy program among primary breast cancer patients treated in community setting s , to determine whether highly distressed patients were most likely to benefit and whether therapist 's training or experience was related to outcome . METHOD Three hundred and fifty-three women within one year of diagnosis with primary breast cancer were r and omly assigned to receive supportive-expressive group therapy or to an education control condition . Participants were recruited from two academic centers and nine oncology practice s , which were members of NCI 's Community Clinical Oncology Program ( CCOP ) and were followed over 2 years . RESULTS A 2x2x19 analysis of variance was conducted with main effects of treatment condition , cohort , and baseline distress and their interactions . There was no main effect for treatment condition after removing one subject with an extreme score .  Highly distressed women did not derive a greater benefit from treatment . Therapist training and psychotherapy experience were not associated with a treatment effect . CONCLUSIONS This study provides no evidence of reduction in distress as the result of a brief supportive-expressive intervention for women with primary breast cancer . Future studies might productively focus on women with higher initial levels of distress The question of whether stress poses a risk for cancer progression has been difficult to answer . A r and omized clinical trial tested the hypothesis that cancer patients coping with their recent diagnosis but receiving a psychologic intervention  would have improved survival compared with patients who were only assessed OBJECTIVES Considerable morbidity persists among survivors of breast cancer ( BC ) including high levels of psychological stress , anxiety , depression , fear of recurrence , and physical symptoms including pain , fatigue , and sleep disturbances , and impaired quality of life . Effective interventions are needed during this difficult transitional period . METHODS We conducted a r and omized controlled trial of 84 female BC survivors ( Stages 0-III ) recruited from the H. Lee Moffitt Cancer and Research Institute . All subjects were within 18 months of treatment completion with surgery and adjuvant radiation and /or chemotherapy .  Subjects were r and omly assigned to a 6-week Mindfulness-Based Stress Reduction ( MBSR ) program design ed to self-regulate arousal to stressful circumstances or symptoms ( n=41 ) or to usual care ( n=43 ) . Outcome measures compared at 6 weeks by r and om assignment included vali date d measures of psychological status ( depression , anxiety , perceived stress , fear of recurrence , optimism , social support ) and psychological and physical subscales of quality of life ( SF-36 ) . RESULTS Compared with usual care , subjects assigned to MBSR(BC ) had significantly lower ( two-sided p<0.05 ) adjusted mean levels of depression ( 6.3 vs 9.6 ) , anxiety ( 28.3 vs 33.0 ) , and fear of recurrence ( 9.3 vs 11.6 ) at 6 weeks , along with higher energy ( 53.5 vs 49.2 ) , physical functioning ( 50.1 vs 47.0 ) , and physical role functioning ( 49.1 vs 42.8 ) . In stratified analyses , subjects more compliant with MBSR tended to experience greater improvements in measures of energy and physical functioning . CONCLUSIONS Among BC survivors within 18 months of treatment completion , a 6-week MBSR(BC ) program result ed in significant improvements in psychological status and quality of life compared with usual care The effects of 8-week cancer support groups ( CSGs ) with and without coaching on adaptation were tested in a sample of 181 women with newly diagnosed early stage breast cancer .  CSG participation with coaching result ed in higher quality of relationship with significant other at CSG conclusion ; this effect was not sustained 8 weeks later . CSG participation had no effect on symptom distress , emotional distress , or functional status . On average , symptom distress was low , emotional distress was moderate , and functional status was relatively high . Independent of CSGs , symptom distress decreased and functional status increased over time from entry into the study to 16 weeks later . Further research is needed to determine the optimal starting time and length for CSGs OBJECTIVE The current report provides the result of a Phase II clinical trial regarding the effectiveness and feasibility of problem-solving therapy for psychological distress experienced by Japanese early-stage breast cancer patients . METHODS Participants were 36 post-surgery Japanese breast cancer patients in a university hospital located in Osaka Prefecture , Japan . After screening for psychological distress using the Distress and Impact Thermometer and the Hospital Anxiety and Depression Scale , highly distressed patients were exposed to 5 weekly sessions of the problem-solving therapy program . RESULTS Nineteen patients completed the intervention and follow-up . There was a significant difference between the pre-intervention and the 3-month follow-up in the total Hospital Anxiety and Depression Scale score ( P = 0.02 ) , and the mean change score from the pre-intervention to the follow-up was 6.05 ( SD = 1.94 ) . The intervention had a large effect size ( d = 0.82 ) . There were also significant changes in worry , self-efficacy and quality of life measures . CONCLUSIONS The findings of our study suggest that the problem-solving therapy program has potential to be effective for alleviating psychological distress experienced by Japanese early-stage breast cancer patients . The true effectiveness of the program should be confirmed by a future r and omized control trial PURPOSE To test the effectiveness of a psycho-educational group intervention to improve psychological distress measured by POMS TMD , Quality of Life measured by European Organisation for Research and Treatment of Cancer ( EORTC ) , the core and breast cancer module , Mental Adjustment measured by MAC and marital relationship measured by BLRI in women with primary breast cancer conducted 10 weeks after surgery . A secondary outcome was 4-year survival . PATIENTS AND METHODS We r and omly assigned 210 patients with primary breast cancer to a control or an intervention group . Patients in the intervention group were offered two weekly 6-h sessions of psycho-education and eight weekly 2-h sessions of group psychotherapy . All participants were followed up for Quality of Life , coping ability and social relations 1 , 6 and 12 months after the intervention and on survival 4 years after surgical treatment . RESULTS No statistically significant effects of the intervention were found on any of the psychosocial question naire outcomes . There were not enough cases of death to analyse overall survival . The only statistically significant result was for patients who used anti depressive medication , for whom almost all measures improved over time , in both the control and intervention groups . CONCLUSION Psycho-education and group psychotherapy did not decrease psychological distress or increase Quality of Life , Mental Adjustment or improve marital relationship among patients with primary breast cancer A Roy adaptation model 
    Output:
    