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: This study examined the relationship between objective ly measured nocturnal hot flashes and objective ly measured sleep in breast cancer survivors with insomnia . Twenty-four women who had completed treatment for non-metastatic breast cancer participated . All were enrolled in a study of cognitive-behavioral treatment for chronic insomnia .  Nocturnal hot flashes and sleep  were measured by skin conductance and polysomnography  , respectively . The 10-minute periods around hot flashes were found to have significantly more wake time , and more stage changes to lighter sleep , than other 10-minute periods during the night . Nights with hot flashes had a significantly higher percentage of wake time , a lower percentage of Stage 2 sleep , and a longer REM latency compared to nights without hot flashes . Overall , hot flashes were found to be associated with less efficient , more disrupted sleep . Nocturnal hot flashes , or their underlying mechanisms , should be considered as potential contributors to sleep disruption in women with breast cancer who report poor sleep BACKGROUND Chronic sleep-onset insomnia is a prevalent health complaint in adults . Although behavioral and pharmacological therapies have been shown to be effective for insomnia , no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia . The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy , singly and in combination , for chronic sleep-onset insomnia . METHODS This was a r and omized , placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia . Interventions included cognitive behavior therapy ( CBT ) , pharmacotherapy , or combination therapy compared with placebo . The main outcome measures were sleep-onset latency as measured by sleep diaries ; secondary measures included sleep diary measures of sleep efficiency and total sleep time , objective measures of sleep variables ( Nightcap sleep monitor recorder ) , and measures of daytime functioning . RESULTS In most measures , CBT was the most sleep effective intervention ; it produced the greatest changes in sleep-onset latency and sleep efficiency , yielded the largest number of normal sleepers after treatment , and maintained therapeutic gains at long-term follow-up . The combined treatment provided no advantage over CBT alone , whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation . CONCLUSIONS These findings suggest that young and middle-age patients with sleep-onset insomnia can derive significantly greater benefit from CBT than pharmacotherapy and that CBT should be considered a first-line intervention for chronic insomnia . Increased recognition of the efficacy of CBT and more widespread recommendations for its use could improve the quality of life of a large numbers of patients with insomnia PURPOSE To determine the effects of breast cancer-specific print material s and step pedometers on  physical activity ( PA ) and quality of life ( QoL ) in breast cancer survivors . PATIENTS AND METHODS Breast cancer survivors ( N = 377 ) were r and omly assigned to receive one of the following : a st and ard public health recommendation for PA , previously developed breast cancer-specific PA print material s , a step pedometer , or a combination of breast cancer-specific print material s and step pedometers . The primary outcome was self-reported moderate/vigorous PA minutes per week . Secondary outcomes were QoL ( Functional Assessment of Cancer Therapy-Breast ) , fatigue , self-reported brisk walking , and objective step counts . Assessment s were conducted at baseline and postintervention ( 12 weeks ) . RESULTS Attrition was 10.3 % ( 39 of 377 ) . On the basis of linear mixed-model analyses , PA increased by 30 minutes/week in the st and ard recommendation group compared with 70 minutes/week in the print material group ( mean difference , 39 minutes/week ; 95 % CI = -10 to 89 ; d = 0.25 ; P = .117 ) , 89 minutes/week in the pedometer group ( mean difference , 59 minutes/week ; 95 % CI , 11 to 108 ; d = 0.38 ; P = .017 ) , and 87 minutes/week in the combined group ( mean difference , 57 minutes/week ; 95 % CI , 8 to 106 ; d = 0.37 ; P = .022 ) . For brisk walking minutes/week , all three intervention groups reported significantly greater increases than the st and ard recommendation group . The combined group also reported significantly improved QoL ( mean difference , 5.8 ; 95 % CI , 2.0 to 9.6 ; d = 0.33 ; P = .003 ) and reduced fatigue ( mean difference , 2.3 ; 95 % CI , 0.0 to 4.7 ; d = 0.25 ; P = .052 ) compared with the st and ard recommendation group . CONCLUSION Breast cancer-specific PA print material s and pedometers may be effective strategies for increasing PA and QoL in breast cancer survivors . A combined approach appears to be optimal . CLINICAL TRIAL REGISTRATION Clinical Trials.gov Identifier Lymphedema is a chronic and progressive long-term adverse effect of breast cancer treatment commonly defined by swelling of the affected arm . Current clinical guidelines indicate that women with and at risk for lymphedema should protect the affected arm from overuse . In clinical practice , this often translates into risk aversive guidance to avoid using the arm . This could lead to a disuse pattern that may increase the likelihood of injury from common activities of daily living . Further , such guidance poses an additional barrier to staying physically active , potentially translating to weight gain , which has been shown to be associated with worse clinical course for women with lymphedema . We hypothesize that a program of slowly progressive strength training with no upper limit on the amount of weight that may be lifted would gradually increase the physiologic capacity of the arm so that common activities represent a decreasing percentage of maximal capacity . Theoretically , this increased capacity should decrease the risk that daily activities put stress on the lymphatic system of the affected side . The Physical Activity and Lymphedema ( PAL ) Trial is a recently completed r and omized controlled exercise intervention trial that recruited 295 breast cancer survivors ( 141 with lymphedema at study entry , 154 at risk for lymphedema at study entry ) . The purpose of this report is to provide detail regarding the study design , statistical design , and protocol of the PAL trial PURPOSE Evidence suggests that the re-entry phase ( ie , early period after medical treatment completion ) presents distinct challenges for cancer patients . To facilitate the transition to recovery , we conducted the Moving Beyond Cancer ( MBC ) trial , a multisite , r and omized , controlled trial of psychoeducational interventions for breast cancer patients . METHODS Breast cancer patients were registered within 6 weeks after surgery . After medical treatment , they completed baseline measures and were r and omly assigned to st and ard National Cancer Institute print material ( CTL ) ; st and ard print material and peer-modeling videotape ( VID ) ; or st and ard print material , videotape , two sessions with a trained cancer educator , and informational workbook ( EDU ) . Two primary end points were examined : energy/fatigue and cancer-specific distress . Secondary end points were depressive symptoms and post-traumatic growth . Perceived preparedness for re-entry was analyzed as a moderator of effects . RESULTS Of 558 women r and omly assigned to treatment , 418 completed the 6-month assessment and 399 completed the 12-month assessment . In analyses controlling for study site and baseline depressive symptoms , VID produced significant improvement in energy/fatigue at 6 months relative to CTL , particularly among women who felt less prepared for re-entry at baseline . No significant main effect of the interventions emerged on cancer-specific distress , but EDU prompted greater reduction in this outcome relative to CTL at 6 months for patients who felt more prepared for re-entry . Between-group differences in the primary outcomes were not significant at 12 months , and no significant effects emerged on the secondary end points . CONCLUSION A peer-modeling videotape can accelerate the recovery of energy during the re-entry phase in women treated for breast cancer , particularly among those who feel less prepared for re-entry PURPOSE We previously evaluated fatigue , menopausal symptoms , and cognitive dysfunction in patients receiving adjuvant therapy for breast cancer and matched healthy women . Here we report assessment of these women 1 and 2 years later . PATIENTS AND METHODS Patients without relapse and controls were evaluated by the Functional Assessment of Cancer Treatment-General Quality of Life question naire , with subscales for fatigue and endocrine symptoms , and by the High Sensitivity Cognitive Screen . RESULTS There were 104 , 91 , and 83 patients and 102 , 81 , and 81 controls assessed at baseline and at 1 and 2 years , respectively . Median Functional Assessment of Cancer Treatment-Fatigue scores ( range , 0 to 52 ) for patients improved from 31 ( on chemotherapy ) to 43 and 45 at 1 and 2 years , respectively , but were stable in controls ( 46 to 48 ) . Median Functional Assessment of Cancer Treatment-Endocrine Symptoms scores ( range , 0 to 72 ) for patients improved from 57 ( on chemotherapy ) to 59 and 61 at 1 and 2 years , respectively , and were stable in controls ( 64 to 65 ) . Differences between patients and controls remained significant for these scales . The incidence of moderate-severe cognitive dysfunction by the High Sensitivity Cognitive Screen  decreased in patients from 16 % ( on chemotherapy ) to 4.4 % and 3.8 % and in controls from 5 % to 3.6 % and 0 % at 1 and 2 years , respectively . There were minimal differences between estrogen receptor-positive patients who started hormonal therapy ( mainly tamoxifen ) after chemotherapy and estrogen receptor-negative patients who did not . Differences in quality of life between patients and controls were significant only at baseline . CONCLUSION Fatigue , menopausal symptoms , and cognitive dysfunction are important adverse effects of chemotherapy that improve in most patients . Hormonal treatment has minimal impact on them BACKGROUND Knowledge of sleep aid use is limited despite the high prevalence of insomnia among women before , during , and following breast cancer adjuvant chemotherapy treatments ( CTX ) . This study 's purpose was to ( 1 ) determine the frequency and characteristics of participants taking sleep aid(s ) ; ( 2 ) identify the frequency and percentage of sleep aid use by category ( prescription sedative/hypnotics , prescription anti-depressants , prescription analgesics , prescription anti-emetics , over-the-counter ( OTC ) analgesics , OTC cold/flu/sinus , OTC sleep , alcohol , and herbal supplements ) ; and ( 3 ) compare sleep aid use by category in the experimental and control groups within a r and omized-controlled clinical trial ( RCT ) . METHODS Longitudinal , descriptive , secondary RCT data analysis of women ( n=219 ) receiving out-patient CTX , and at 30 , 60 , and 90 days following the last CTX and 1 year following CTX1 . Participants recorded daily sleep aid use on a Sleep Diary . Analyses included descriptives , chi-square , and RM-ANOVA . RESULTS Approximately 20 % of participants took at least one  sleep aid  before CTX1 ; usage decreased over time ( 12 - 18 % ) ; a second sleep aid was used infrequently . Prescription sedative/hypnotics ( 46 % ) and OTC analgesics  ( 24 % ) were used most frequently . OTC sleep aids  were most commonly used as a second aid . Prescription sedative/hypnotics [ F(7,211)=4.26 , p=0.00 ] and OTC analgesics [ F(7,211)=2.38 , p=0.023 ] use decreased significantly over time . CONCLUSIONS Results reflect the natural course of CTX , recovery , and healing . Comprehensive screening for sleep-wake disturbances and sleep aid use may lead to a better underst and ing of the risks and benefits of pharmacologic and non-pharmacologic interventions , and ultimately lead to selection of the safest and most effective treatment The authors report a 3-year follow-up of the effects of 8-week support group interventions on the quality of life of women with early stage breast cancer . Shortly after diagnosis , women were r and omly assigned to 1 of 4 conditions : control , education , peer discussion , and education plus peer discussion . The education group intervention focused on providing information to enhance control over the illness experience , whereas the peer discussion group intervention focused on providing emotional support through the expression of feelings . Consistent with the results that emerged 6 months after the interventions ( V. S. Helgeson , S. Cohen , R. Schulz , & J. Yasko , 1999 ) , the authors found that the benefits of the education intervention were maintained over a 3-year period ( N=252 ) , although effects dissipated with time . The authors continued to find no benefits of the peer discussion intervention , either alone or in combination with education PURPOSE Professionally administered psychosocial interventions have been shown to improve the quality of life of cancer patients undergoing chemotherapy . The present study sought to improve access to psychosocial interventions during chemotherapy treatment by evaluating the efficacy and costs of a patient self-administered form of stress management training that requires limited professional time or experience to deliver . PATIENTS AND METHODS Four hundred eleven patients about to start chemotherapy were r and omly assigned to receive usual psychosocial care only , a professionally administered form of stress management training , or a patient self-administered form of stress management training .  Quality -of 
    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: This study examined the relationship between objective ly measured nocturnal hot flashes and objective ly measured sleep in breast cancer survivors with insomnia . Twenty-four women who had completed treatment for non-metastatic breast cancer participated . All were enrolled in a study of cognitive-behavioral treatment for chronic insomnia .  Nocturnal hot flashes and sleep  were measured by skin conductance and polysomnography  , respectively . The 10-minute periods around hot flashes were found to have significantly more wake time , and more stage changes to lighter sleep , than other 10-minute periods during the night . Nights with hot flashes had a significantly higher percentage of wake time , a lower percentage of Stage 2 sleep , and a longer REM latency compared to nights without hot flashes . Overall , hot flashes were found to be associated with less efficient , more disrupted sleep . Nocturnal hot flashes , or their underlying mechanisms , should be considered as potential contributors to sleep disruption in women with breast cancer who report poor sleep BACKGROUND Chronic sleep-onset insomnia is a prevalent health complaint in adults . Although behavioral and pharmacological therapies have been shown to be effective for insomnia , no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia . The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy , singly and in combination , for chronic sleep-onset insomnia . METHODS This was a r and omized , placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia . Interventions included cognitive behavior therapy ( CBT ) , pharmacotherapy , or combination therapy compared with placebo . The main outcome measures were sleep-onset latency as measured by sleep diaries ; secondary measures included sleep diary measures of sleep efficiency and total sleep time , objective measures of sleep variables ( Nightcap sleep monitor recorder ) , and measures of daytime functioning . RESULTS In most measures , CBT was the most sleep effective intervention ; it produced the greatest changes in sleep-onset latency and sleep efficiency , yielded the largest number of normal sleepers after treatment , and maintained therapeutic gains at long-term follow-up . The combined treatment provided no advantage over CBT alone , whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation . CONCLUSIONS These findings suggest that young and middle-age patients with sleep-onset insomnia can derive significantly greater benefit from CBT than pharmacotherapy and that CBT should be considered a first-line intervention for chronic insomnia . Increased recognition of the efficacy of CBT and more widespread recommendations for its use could improve the quality of life of a large numbers of patients with insomnia PURPOSE To determine the effects of breast cancer-specific print material s and step pedometers on  physical activity ( PA ) and quality of life ( QoL ) in breast cancer survivors . PATIENTS AND METHODS Breast cancer survivors ( N = 377 ) were r and omly assigned to receive one of the following : a st and ard public health recommendation for PA , previously developed breast cancer-specific PA print material s , a step pedometer , or a combination of breast cancer-specific print material s and step pedometers . The primary outcome was self-reported moderate/vigorous PA minutes per week . Secondary outcomes were QoL ( Functional Assessment of Cancer Therapy-Breast ) , fatigue , self-reported brisk walking , and objective step counts . Assessment s were conducted at baseline and postintervention ( 12 weeks ) . RESULTS Attrition was 10.3 % ( 39 of 377 ) . On the basis of linear mixed-model analyses , PA increased by 30 minutes/week in the st and ard recommendation group compared with 70 minutes/week in the print material group ( mean difference , 39 minutes/week ; 95 % CI = -10 to 89 ; d = 0.25 ; P = .117 ) , 89 minutes/week in the pedometer group ( mean difference , 59 minutes/week ; 95 % CI , 11 to 108 ; d = 0.38 ; P = .017 ) , and 87 minutes/week in the combined group ( mean difference , 57 minutes/week ; 95 % CI , 8 to 106 ; d = 0.37 ; P = .022 ) . For brisk walking minutes/week , all three intervention groups reported significantly greater increases than the st and ard recommendation group . The combined group also reported significantly improved QoL ( mean difference , 5.8 ; 95 % CI , 2.0 to 9.6 ; d = 0.33 ; P = .003 ) and reduced fatigue ( mean difference , 2.3 ; 95 % CI , 0.0 to 4.7 ; d = 0.25 ; P = .052 ) compared with the st and ard recommendation group . CONCLUSION Breast cancer-specific PA print material s and pedometers may be effective strategies for increasing PA and QoL in breast cancer survivors . A combined approach appears to be optimal . CLINICAL TRIAL REGISTRATION Clinical Trials.gov Identifier Lymphedema is a chronic and progressive long-term adverse effect of breast cancer treatment commonly defined by swelling of the affected arm . Current clinical guidelines indicate that women with and at risk for lymphedema should protect the affected arm from overuse . In clinical practice , this often translates into risk aversive guidance to avoid using the arm . This could lead to a disuse pattern that may increase the likelihood of injury from common activities of daily living . Further , such guidance poses an additional barrier to staying physically active , potentially translating to weight gain , which has been shown to be associated with worse clinical course for women with lymphedema . We hypothesize that a program of slowly progressive strength training with no upper limit on the amount of weight that may be lifted would gradually increase the physiologic capacity of the arm so that common activities represent a decreasing percentage of maximal capacity . Theoretically , this increased capacity should decrease the risk that daily activities put stress on the lymphatic system of the affected side . The Physical Activity and Lymphedema ( PAL ) Trial is a recently completed r and omized controlled exercise intervention trial that recruited 295 breast cancer survivors ( 141 with lymphedema at study entry , 154 at risk for lymphedema at study entry ) . The purpose of this report is to provide detail regarding the study design , statistical design , and protocol of the PAL trial PURPOSE Evidence suggests that the re-entry phase ( ie , early period after medical treatment completion ) presents distinct challenges for cancer patients . To facilitate the transition to recovery , we conducted the Moving Beyond Cancer ( MBC ) trial , a multisite , r and omized , controlled trial of psychoeducational interventions for breast cancer patients . METHODS Breast cancer patients were registered within 6 weeks after surgery . After medical treatment , they completed baseline measures and were r and omly assigned to st and ard National Cancer Institute print material ( CTL ) ; st and ard print material and peer-modeling videotape ( VID ) ; or st and ard print material , videotape , two sessions with a trained cancer educator , and informational workbook ( EDU ) . Two primary end points were examined : energy/fatigue and cancer-specific distress . Secondary end points were depressive symptoms and post-traumatic growth . Perceived preparedness for re-entry was analyzed as a moderator of effects . RESULTS Of 558 women r and omly assigned to treatment , 418 completed the 6-month assessment and 399 completed the 12-month assessment . In analyses controlling for study site and baseline depressive symptoms , VID produced significant improvement in energy/fatigue at 6 months relative to CTL , particularly among women who felt less prepared for re-entry at baseline . No significant main effect of the interventions emerged on cancer-specific distress , but EDU prompted greater reduction in this outcome relative to CTL at 6 months for patients who felt more prepared for re-entry . Between-group differences in the primary outcomes were not significant at 12 months , and no significant effects emerged on the secondary end points . CONCLUSION A peer-modeling videotape can accelerate the recovery of energy during the re-entry phase in women treated for breast cancer , particularly among those who feel less prepared for re-entry PURPOSE We previously evaluated fatigue , menopausal symptoms , and cognitive dysfunction in patients receiving adjuvant therapy for breast cancer and matched healthy women . Here we report assessment of these women 1 and 2 years later . PATIENTS AND METHODS Patients without relapse and controls were evaluated by the Functional Assessment of Cancer Treatment-General Quality of Life question naire , with subscales for fatigue and endocrine symptoms , and by the High Sensitivity Cognitive Screen . RESULTS There were 104 , 91 , and 83 patients and 102 , 81 , and 81 controls assessed at baseline and at 1 and 2 years , respectively . Median Functional Assessment of Cancer Treatment-Fatigue scores ( range , 0 to 52 ) for patients improved from 31 ( on chemotherapy ) to 43 and 45 at 1 and 2 years , respectively , but were stable in controls ( 46 to 48 ) . Median Functional Assessment of Cancer Treatment-Endocrine Symptoms scores ( range , 0 to 72 ) for patients improved from 57 ( on chemotherapy ) to 59 and 61 at 1 and 2 years , respectively , and were stable in controls ( 64 to 65 ) . Differences between patients and controls remained significant for these scales . The incidence of moderate-severe cognitive dysfunction by the High Sensitivity Cognitive Screen  decreased in patients from 16 % ( on chemotherapy ) to 4.4 % and 3.8 % and in controls from 5 % to 3.6 % and 0 % at 1 and 2 years , respectively . There were minimal differences between estrogen receptor-positive patients who started hormonal therapy ( mainly tamoxifen ) after chemotherapy and estrogen receptor-negative patients who did not . Differences in quality of life between patients and controls were significant only at baseline . CONCLUSION Fatigue , menopausal symptoms , and cognitive dysfunction are important adverse effects of chemotherapy that improve in most patients . Hormonal treatment has minimal impact on them BACKGROUND Knowledge of sleep aid use is limited despite the high prevalence of insomnia among women before , during , and following breast cancer adjuvant chemotherapy treatments ( CTX ) . This study 's purpose was to ( 1 ) determine the frequency and characteristics of participants taking sleep aid(s ) ; ( 2 ) identify the frequency and percentage of sleep aid use by category ( prescription sedative/hypnotics , prescription anti-depressants , prescription analgesics , prescription anti-emetics , over-the-counter ( OTC ) analgesics , OTC cold/flu/sinus , OTC sleep , alcohol , and herbal supplements ) ; and ( 3 ) compare sleep aid use by category in the experimental and control groups within a r and omized-controlled clinical trial ( RCT ) . METHODS Longitudinal , descriptive , secondary RCT data analysis of women ( n=219 ) receiving out-patient CTX , and at 30 , 60 , and 90 days following the last CTX and 1 year following CTX1 . Participants recorded daily sleep aid use on a Sleep Diary . Analyses included descriptives , chi-square , and RM-ANOVA . RESULTS Approximately 20 % of participants took at least one  sleep aid  before CTX1 ; usage decreased over time ( 12 - 18 % ) ; a second sleep aid was used infrequently . Prescription sedative/hypnotics ( 46 % ) and OTC analgesics  ( 24 % ) were used most frequently . OTC sleep aids  were most commonly used as a second aid . Prescription sedative/hypnotics [ F(7,211)=4.26 , p=0.00 ] and OTC analgesics [ F(7,211)=2.38 , p=0.023 ] use decreased significantly over time . CONCLUSIONS Results reflect the natural course of CTX , recovery , and healing . Comprehensive screening for sleep-wake disturbances and sleep aid use may lead to a better underst and ing of the risks and benefits of pharmacologic and non-pharmacologic interventions , and ultimately lead to selection of the safest and most effective treatment The authors report a 3-year follow-up of the effects of 8-week support group interventions on the quality of life of women with early stage breast cancer . Shortly after diagnosis , women were r and omly assigned to 1 of 4 conditions : control , education , peer discussion , and education plus peer discussion . The education group intervention focused on providing information to enhance control over the illness experience , whereas the peer discussion group intervention focused on providing emotional support through the expression of feelings . Consistent with the results that emerged 6 months after the interventions ( V. S. Helgeson , S. Cohen , R. Schulz , & J. Yasko , 1999 ) , the authors found that the benefits of the education intervention were maintained over a 3-year period ( N=252 ) , although effects dissipated with time . The authors continued to find no benefits of the peer discussion intervention , either alone or in combination with education PURPOSE Professionally administered psychosocial interventions have been shown to improve the quality of life of cancer patients undergoing chemotherapy . The present study sought to improve access to psychosocial interventions during chemotherapy treatment by evaluating the efficacy and costs of a patient self-administered form of stress management training that requires limited professional time or experience to deliver . PATIENTS AND METHODS Four hundred eleven patients about to start chemotherapy were r and omly assigned to receive usual psychosocial care only , a professionally administered form of stress management training , or a patient self-administered form of stress management training .  Quality -of 
    Output:
    