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 Due to early detection and advances in treatment , the number of women surviving breast cancer is increasing . Whilst there are many positive aspects of improved survival , breast cancer survival is associated with many long-term health and psychosocial sequelae . Engaging in regular physical activity post-diagnosis can reduce this burden . Despite this evidence , the majority of breast cancer survivors do not engage in regular physical activity . The challenge is to provide breast cancer survivors with appealing and effective physical activity support in a sustainable and cost-effective way . This article describes the protocol for the Move More for Life Study , which aims to assess the relative efficacy of two promising theory-based , print interventions design ed to promote regular physical activity amongst breast cancer survivors . Method and design Breast cancer survivors were recruited from across Australia . Participants will be r and omised into one of three groups : ( 1 ) A tailored-print intervention group , ( 2 ) a targeted-print intervention group , or ( 3 ) a st and ard recommendation control group . Participants in the tailored-print intervention group will receive 3 tailored newsletters in the mail over a three month period . Participants in the targeted-print group will receive a previously developed physical activity guidebook design ed specifically for breast cancer survivors immediately after baseline . Participants in the st and ard recommendation control will receive a brochure detailing the physical activity guidelines for Australian adults . All participants will be assessed at baseline , and at 4 and 10 months post-baseline . Intervention efficacy for changing the primary outcomes ( mins/wk aerobic physical activity ; sessions/exercises per week resistance physical activity ) and secondary outcomes ( steps per day , health-related quality life , compliance with physical activity guidelines , fatigue ) will be assessed . Mediation and moderation analyses will also be conducted . Discussion Given the growing number of cancer survivors , distance-based behaviour change programs addressing physical activity have the potential to make a significant public health impact . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) identifier : Background Limited research has examined the association between physical activity , health-related fitness , and disease outcomes in breast cancer survivors . Here , we present the rationale and design of the Alberta Moving Beyond Breast Cancer ( AMBER ) Study , a prospect i ve cohort study design ed specifically to examine the role of physical activity and health-related fitness in breast cancer survivorship from the time of diagnosis and for the balance of life . The AMBER Study will examine the role of physical activity and health-related fitness in facilitating treatment completion , alleviating treatment side effects , hastening recovery after treatments , improving long term quality of life , and reducing the risks of disease recurrence , other chronic diseases , and premature death . Methods / Design The AMBER Study will enroll 1500 newly diagnosed , incident , stage I-IIIc breast cancer survivors in Alberta , Canada over a 5 year period . Assessment s will be made at baseline ( within 90 days of surgery ) , 1 year , and 3 years consisting of objective and self-reported measurements of physical activity , health-related fitness , blood collection , lymphedema , patient-reported outcomes , and determinants of physical activity . A final assessment at 5 years will measure patient-reported data only . The cohort members will be followed for an additional 5 years for disease outcomes . Discussion The AMBER cohort will answer key questions related to physical activity and health-related fitness in breast cancer survivors including : ( 1 ) the independent and interactive associations of physical activity and health-related fitness with disease outcomes ( e.g. , recurrence , breast cancer-specific mortality , overall survival ) , treatment completion rates , symptoms and side effects ( e.g. , pain , lymphedema , fatigue , neuropathy ) , quality of life , and psychosocial functioning ( e.g. , anxiety , depression , self-esteem , happiness ) , ( 2 ) the determinants of physical activity and health-related fitness including demographic , medical , social cognitive , and environmental variables , ( 3 ) the mediators of any observed associations between physical activity , health-related fitness , and health outcomes including biological , functional , and psychosocial , and ( 4 ) the moderators of any observed associations including demographic , medical , and biological/disease factors . Taken together , these data will provide a comprehensive inquiry into the outcomes , determinants , mechanisms , and moderators of physical activity and health-related fitness in breast cancer survivors PURPOSE The 2000 National Institutes of Health Consensus Conference on Adjuvant Therapy of Breast Cancer recommended chemotherapy for all women with invasive cancer greater than 1 centimeter . Studies of long-term breast cancer survivors have found poorer quality of life ( QOL ) in women who received adjuvant chemotherapy .  The aim of this article is to characterize physical and psychosocial recovery as a function of chemotherapy receipt in the year after medical treatment completion . PATIENTS AND METHODS Prospect i ve longitudinal survey data ( R AND SF-36 and Breast Cancer Prevention Trial [ BCPT ] Symptom Scales ) collected from 558 women with breast cancer enrolled on the Moving Beyond Cancer ( MBC ) psychoeducational intervention trial were compared according to receipt of chemotherapy . MBC study enrollment occurred within 4 weeks after the end of primary treatment ( eg , surgery , chemotherapy , radiation ) . Self-report question naire data collected at enrollment and at 2 , 6 , and 12 months thereafter were examined , controlling for intervention and with propensity score adjustment for imbalance of covariates . Outcome analyses were carried out by fitting linear mixed models by using SAS PROC MIXED . RESULTS Longitudinal SF-36 scale scores did not differ by chemotherapy treatment exposure , and both groups improved significantly ( P < .01 ) in the year after primary treatment ended . However , adjuvant chemotherapy treatment was associated with significantly more severe physical symptoms , including musculoskeletal pain ( P = .01 ) , vaginal problems ( P < .01 ) , weight problems ( P = .01 ) , and nausea ( P = .03 ) . CONCLUSION Physical and psychosocial functioning improved significantly after breast cancer treatment , independent of receipt of adjuvant chemotherapy .  Women who received chemotherapy experienced more severe and persistent physical symptoms that should be more effectively managed as part of survivorship care Background Radiation therapy is an essential modality in the treatment of breast cancer . Addition of radiotherapy to surgery has significantly increased local control and survival rates of the disease . However , radiotherapy is also associated with side effects , such as tissue fibrosis or enhanced vascular morbidity . Modern radiotherapy strategies , such as intensity modulated radiotherapy ( IMRT ) , can shorten the overall treatment time by integration of the additional tumor bed boost significantly . To what extent this might be possible without impairing treatment outcome and cosmetic results remains to be clarified . Methods / Design The IMRT-MC2 study is a prospect i ve , two armed , multicenter , r and omized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery . 502 patients will be recruited and r and omized into two arms : patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor bed by integrated boost , while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and consecutive boost in 8 fractions to a total dose of 66.4 Gy . Discussion Primary objectives of the study are the evaluation of the cosmetic results 6 weeks and 2 years post treatment and the 2- and 5-year local recurrence rates for the two different radiotherapy strategies . Secondary objectives are long term overall survival , disease free survival and quality of life . Trial Registration Clinical Trials.gov Protocol ID : NCT01322854 Background Few data exist on survival or health-related quality of life ( QOL ) related to herbal remedy use among long-term breast cancer survivors . The objective of this report is to examine whether herbal remedy use is associated with survival or the health-related QOL of these long-term breast cancer survivors . Methods In 1999 - 2000 , we collected the information of herbal remedy use and QOL during a telephone interview with 371 Los Angeles Non-Hispanic/Hispanic white women who had survived more than 10 years after breast cancer diagnosis .  QOL was measured using the Medical Outcomes Study Short Form-36 ( SF-36 ) question naire . Patients were followed for mortality from the baseline interview through 2007 . 299 surviving patients completed a second telephone interview on QOL in 2002 - 2004 . We used multivariable Cox proportional hazards methods to estimate relative risks ( RR ) and 95 % confidence intervals ( CI ) for mortality and applied multivariable linear regression models to compare average SF-36 change scores ( follow-up - baseline ) between herbal remedy users and non-users . Results Fifty-nine percent of participants were herbal remedy users at baseline . The most commonly used herbal remedies were echinacea , herbal teas , and ginko biloba . Herbal remedy use was associated with non-statistically significant increases in the risks for all-cause ( 44 deaths , RR = 1.28 , 95 % CI = 0.62 - 2.64 ) and breast cancer ( 33 deaths , RR = 1.78 , 95 % CI = 0.72 - 4.40 ) mortality . Both herbal remedy users ' and non-users ' mental component summary scores on the SF-36 increased similarly from the first survey to the second survey ( P = 0.16 ) , but herbal remedy users ' physical component summary scores decreased more than those of non-users ( -5.7 vs. -3.2 , P = 0.02 ) . Conclusions Our data provide some evidence that herbal remedy use is associated with poorer survival and a poorer physical component score for health-related QOL among women who have survived breast cancer for at least 10 years . These conclusions are based on exploratory analyses of data from a prospect i ve study using two-sided statistical tests with no correction for multiple testing and are limited by few deaths for mortality analysis and lack of information on when herbal remedy use was initiated or duration of or reasons for use Background We evaluate trade-offs between quality of life ( QoL ) and survival improvement for two chemotherapy regimens in advanced breast cancer . We also report on the  long-term survival of patients in the ANZ 8614 clinical trial . Methods A total of 391 patients were r and omized to mitoxantrone ( 14 mg/m2 intravenously every 21 days ) or a combination of cyclophosphamide 100 mg/m2 and prednisone 40 mg/m2 orally days 1 to 14 plus methotrexate 40 mg/m2 and 5-fluorouracil 600 mg/m2 intravenously days 1 and 8 every 28 days ( CMFP ) .  QoL was self-assessed on 14 linear analog scales . We computed the mean differences between the two treatments as products of the mean differences in global QoL , progression-free survival and overall survival . Results CMFP led to a higher overall tumor response ( 39 % vs. 25 % , P=0.004 ) and longer progression-free survival ( PFS ) ( median 5.6 vs 3.9 months , P=0.02 ) but with significantly more toxicity from alopecia , mucositis , diarrhea , anemia and lethargy . Overall survival ( OS ) was similar in the two groups ( median 10.1 vs 11.6 months , P=0.81 ) . QoL over the first 12 weeks was rated better by patients on CMFP for mood ( P=0.04 ) , nausea and vomiting ( P=0.01 ) , and feeling sick ( P=0.02 ) but worse for hair loss ( P<0.0001 ) . A weighted combination of individual QoL items favoured CMFP ( subset score mean difference 2.4 , P=0.03 ) . A global QoL score tended to favour CMFP ( global score mean difference 1.7 , P=0.18 ) . Quality -adjusted PFS was significantly longer with CMFP ( mean 7.208 vs 5.965 months , P=0.04 ) , but quality -adjusted OS was not significantly different ( mean 11.832 vs 11.315 months , P=0.57 ) . Conclusion Despite the greater toxicity , the superior antitumor activity of CMFP led to an overall improvement in quality -adjusted PFS . In advanced breast cancer , in clinical decision making about treatment for palliative intent , the principle used to assess trade-offs between antitumor efficacy and toxicity remains relevant and applicable to all modern therapeutic agents Background Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients . However , it is associated with considerable side effects that negatively affect patients ’ quality of life and cause non-adherence . The recently demonstrated effect of individual expectations on side-effect development ( nocebo effect ) suggests that psychological factors play a role in the prevention of side effects . The aim of this study is to evaluate cognitive-behavioral side-effect prevention training ( SEPT ) for breast cancer patients . This article describes the study protocol and applied research methods . Methods / Design In a r and omized controlled trial , 184 female breast cancer patients are assigned to receive either SEPT , st and ard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment . SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy , imagination-training to integrate positive aspects of medication into daily life 
    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 Due to early detection and advances in treatment , the number of women surviving breast cancer is increasing . Whilst there are many positive aspects of improved survival , breast cancer survival is associated with many long-term health and psychosocial sequelae . Engaging in regular physical activity post-diagnosis can reduce this burden . Despite this evidence , the majority of breast cancer survivors do not engage in regular physical activity . The challenge is to provide breast cancer survivors with appealing and effective physical activity support in a sustainable and cost-effective way . This article describes the protocol for the Move More for Life Study , which aims to assess the relative efficacy of two promising theory-based , print interventions design ed to promote regular physical activity amongst breast cancer survivors . Method and design Breast cancer survivors were recruited from across Australia . Participants will be r and omised into one of three groups : ( 1 ) A tailored-print intervention group , ( 2 ) a targeted-print intervention group , or ( 3 ) a st and ard recommendation control group . Participants in the tailored-print intervention group will receive 3 tailored newsletters in the mail over a three month period . Participants in the targeted-print group will receive a previously developed physical activity guidebook design ed specifically for breast cancer survivors immediately after baseline . Participants in the st and ard recommendation control will receive a brochure detailing the physical activity guidelines for Australian adults . All participants will be assessed at baseline , and at 4 and 10 months post-baseline . Intervention efficacy for changing the primary outcomes ( mins/wk aerobic physical activity ; sessions/exercises per week resistance physical activity ) and secondary outcomes ( steps per day , health-related quality life , compliance with physical activity guidelines , fatigue ) will be assessed . Mediation and moderation analyses will also be conducted . Discussion Given the growing number of cancer survivors , distance-based behaviour change programs addressing physical activity have the potential to make a significant public health impact . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) identifier : Background Limited research has examined the association between physical activity , health-related fitness , and disease outcomes in breast cancer survivors . Here , we present the rationale and design of the Alberta Moving Beyond Breast Cancer ( AMBER ) Study , a prospect i ve cohort study design ed specifically to examine the role of physical activity and health-related fitness in breast cancer survivorship from the time of diagnosis and for the balance of life . The AMBER Study will examine the role of physical activity and health-related fitness in facilitating treatment completion , alleviating treatment side effects , hastening recovery after treatments , improving long term quality of life , and reducing the risks of disease recurrence , other chronic diseases , and premature death . Methods / Design The AMBER Study will enroll 1500 newly diagnosed , incident , stage I-IIIc breast cancer survivors in Alberta , Canada over a 5 year period . Assessment s will be made at baseline ( within 90 days of surgery ) , 1 year , and 3 years consisting of objective and self-reported measurements of physical activity , health-related fitness , blood collection , lymphedema , patient-reported outcomes , and determinants of physical activity . A final assessment at 5 years will measure patient-reported data only . The cohort members will be followed for an additional 5 years for disease outcomes . Discussion The AMBER cohort will answer key questions related to physical activity and health-related fitness in breast cancer survivors including : ( 1 ) the independent and interactive associations of physical activity and health-related fitness with disease outcomes ( e.g. , recurrence , breast cancer-specific mortality , overall survival ) , treatment completion rates , symptoms and side effects ( e.g. , pain , lymphedema , fatigue , neuropathy ) , quality of life , and psychosocial functioning ( e.g. , anxiety , depression , self-esteem , happiness ) , ( 2 ) the determinants of physical activity and health-related fitness including demographic , medical , social cognitive , and environmental variables , ( 3 ) the mediators of any observed associations between physical activity , health-related fitness , and health outcomes including biological , functional , and psychosocial , and ( 4 ) the moderators of any observed associations including demographic , medical , and biological/disease factors . Taken together , these data will provide a comprehensive inquiry into the outcomes , determinants , mechanisms , and moderators of physical activity and health-related fitness in breast cancer survivors PURPOSE The 2000 National Institutes of Health Consensus Conference on Adjuvant Therapy of Breast Cancer recommended chemotherapy for all women with invasive cancer greater than 1 centimeter . Studies of long-term breast cancer survivors have found poorer quality of life ( QOL ) in women who received adjuvant chemotherapy .  The aim of this article is to characterize physical and psychosocial recovery as a function of chemotherapy receipt in the year after medical treatment completion . PATIENTS AND METHODS Prospect i ve longitudinal survey data ( R AND SF-36 and Breast Cancer Prevention Trial [ BCPT ] Symptom Scales ) collected from 558 women with breast cancer enrolled on the Moving Beyond Cancer ( MBC ) psychoeducational intervention trial were compared according to receipt of chemotherapy . MBC study enrollment occurred within 4 weeks after the end of primary treatment ( eg , surgery , chemotherapy , radiation ) . Self-report question naire data collected at enrollment and at 2 , 6 , and 12 months thereafter were examined , controlling for intervention and with propensity score adjustment for imbalance of covariates . Outcome analyses were carried out by fitting linear mixed models by using SAS PROC MIXED . RESULTS Longitudinal SF-36 scale scores did not differ by chemotherapy treatment exposure , and both groups improved significantly ( P < .01 ) in the year after primary treatment ended . However , adjuvant chemotherapy treatment was associated with significantly more severe physical symptoms , including musculoskeletal pain ( P = .01 ) , vaginal problems ( P < .01 ) , weight problems ( P = .01 ) , and nausea ( P = .03 ) . CONCLUSION Physical and psychosocial functioning improved significantly after breast cancer treatment , independent of receipt of adjuvant chemotherapy .  Women who received chemotherapy experienced more severe and persistent physical symptoms that should be more effectively managed as part of survivorship care Background Radiation therapy is an essential modality in the treatment of breast cancer . Addition of radiotherapy to surgery has significantly increased local control and survival rates of the disease . However , radiotherapy is also associated with side effects , such as tissue fibrosis or enhanced vascular morbidity . Modern radiotherapy strategies , such as intensity modulated radiotherapy ( IMRT ) , can shorten the overall treatment time by integration of the additional tumor bed boost significantly . To what extent this might be possible without impairing treatment outcome and cosmetic results remains to be clarified . Methods / Design The IMRT-MC2 study is a prospect i ve , two armed , multicenter , r and omized phase-III-trial comparing intensity modulated radiotherapy with integrated boost to conventional radiotherapy with consecutive boost in patients with breast cancer after breast conserving surgery . 502 patients will be recruited and r and omized into two arms : patients in arm A will receive IMRT in 28 fractions delivering 50.4 Gy to the breast and 64.4 Gy to the tumor bed by integrated boost , while patients in arm B will receive conventional radiotherapy of the breast in 28 fractions to a dose of 50.4 Gy and consecutive boost in 8 fractions to a total dose of 66.4 Gy . Discussion Primary objectives of the study are the evaluation of the cosmetic results 6 weeks and 2 years post treatment and the 2- and 5-year local recurrence rates for the two different radiotherapy strategies . Secondary objectives are long term overall survival , disease free survival and quality of life . Trial Registration Clinical Trials.gov Protocol ID : NCT01322854 Background Few data exist on survival or health-related quality of life ( QOL ) related to herbal remedy use among long-term breast cancer survivors . The objective of this report is to examine whether herbal remedy use is associated with survival or the health-related QOL of these long-term breast cancer survivors . Methods In 1999 - 2000 , we collected the information of herbal remedy use and QOL during a telephone interview with 371 Los Angeles Non-Hispanic/Hispanic white women who had survived more than 10 years after breast cancer diagnosis .  QOL was measured using the Medical Outcomes Study Short Form-36 ( SF-36 ) question naire . Patients were followed for mortality from the baseline interview through 2007 . 299 surviving patients completed a second telephone interview on QOL in 2002 - 2004 . We used multivariable Cox proportional hazards methods to estimate relative risks ( RR ) and 95 % confidence intervals ( CI ) for mortality and applied multivariable linear regression models to compare average SF-36 change scores ( follow-up - baseline ) between herbal remedy users and non-users . Results Fifty-nine percent of participants were herbal remedy users at baseline . The most commonly used herbal remedies were echinacea , herbal teas , and ginko biloba . Herbal remedy use was associated with non-statistically significant increases in the risks for all-cause ( 44 deaths , RR = 1.28 , 95 % CI = 0.62 - 2.64 ) and breast cancer ( 33 deaths , RR = 1.78 , 95 % CI = 0.72 - 4.40 ) mortality . Both herbal remedy users ' and non-users ' mental component summary scores on the SF-36 increased similarly from the first survey to the second survey ( P = 0.16 ) , but herbal remedy users ' physical component summary scores decreased more than those of non-users ( -5.7 vs. -3.2 , P = 0.02 ) . Conclusions Our data provide some evidence that herbal remedy use is associated with poorer survival and a poorer physical component score for health-related QOL among women who have survived breast cancer for at least 10 years . These conclusions are based on exploratory analyses of data from a prospect i ve study using two-sided statistical tests with no correction for multiple testing and are limited by few deaths for mortality analysis and lack of information on when herbal remedy use was initiated or duration of or reasons for use Background We evaluate trade-offs between quality of life ( QoL ) and survival improvement for two chemotherapy regimens in advanced breast cancer . We also report on the  long-term survival of patients in the ANZ 8614 clinical trial . Methods A total of 391 patients were r and omized to mitoxantrone ( 14 mg/m2 intravenously every 21 days ) or a combination of cyclophosphamide 100 mg/m2 and prednisone 40 mg/m2 orally days 1 to 14 plus methotrexate 40 mg/m2 and 5-fluorouracil 600 mg/m2 intravenously days 1 and 8 every 28 days ( CMFP ) .  QoL was self-assessed on 14 linear analog scales . We computed the mean differences between the two treatments as products of the mean differences in global QoL , progression-free survival and overall survival . Results CMFP led to a higher overall tumor response ( 39 % vs. 25 % , P=0.004 ) and longer progression-free survival ( PFS ) ( median 5.6 vs 3.9 months , P=0.02 ) but with significantly more toxicity from alopecia , mucositis , diarrhea , anemia and lethargy . Overall survival ( OS ) was similar in the two groups ( median 10.1 vs 11.6 months , P=0.81 ) . QoL over the first 12 weeks was rated better by patients on CMFP for mood ( P=0.04 ) , nausea and vomiting ( P=0.01 ) , and feeling sick ( P=0.02 ) but worse for hair loss ( P<0.0001 ) . A weighted combination of individual QoL items favoured CMFP ( subset score mean difference 2.4 , P=0.03 ) . A global QoL score tended to favour CMFP ( global score mean difference 1.7 , P=0.18 ) . Quality -adjusted PFS was significantly longer with CMFP ( mean 7.208 vs 5.965 months , P=0.04 ) , but quality -adjusted OS was not significantly different ( mean 11.832 vs 11.315 months , P=0.57 ) . Conclusion Despite the greater toxicity , the superior antitumor activity of CMFP led to an overall improvement in quality -adjusted PFS . In advanced breast cancer , in clinical decision making about treatment for palliative intent , the principle used to assess trade-offs between antitumor efficacy and toxicity remains relevant and applicable to all modern therapeutic agents Background Adjuvant endocrine therapy can improve disease-free survival and time before recurrence in breast cancer patients . However , it is associated with considerable side effects that negatively affect patients ’ quality of life and cause non-adherence . The recently demonstrated effect of individual expectations on side-effect development ( nocebo effect ) suggests that psychological factors play a role in the prevention of side effects . The aim of this study is to evaluate cognitive-behavioral side-effect prevention training ( SEPT ) for breast cancer patients . This article describes the study protocol and applied research methods . Methods / Design In a r and omized controlled trial , 184 female breast cancer patients are assigned to receive either SEPT , st and ard medical care or a manualized supportive therapy at the start of adjuvant endocrine treatment . SEPT consists of three sessions of cognitive-behavioral training including psychoeducation to provide a realistic view of endocrine therapy , imagination-training to integrate positive aspects of medication into daily life 
    Output:
    