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: OBJECTIVE To evaluate the efficacy of an interactive self-help workbook in reducing distress , and improving quality of life ( QOL ) and coping for women recently diagnosed with breast cancer . DESIGN R and omised controlled trial comparing the use of the workbook and that of an information booklet . PARTICIPANTS AND SETTING 49 women with Stage 0 to II breast cancer diagnosed in the previous month and recruited from 1 February 2007 to 1 February 2008 , in two urban Australian public hospitals . MAIN OUTCOME MEASURES The primary outcome measures were depression , anxiety , and posttraumatic stress . Secondary outcomes included QOL , body image , and the coping styles helplessness/hopelessness , cognitive avoidance and anxious preoccupation . RESULTS After controlling for baseline levels , interactions at 3-month follow-up showed that participants in the workbook group had significantly lower levels of posttraumatic stress ( F[1,89 ] = 7.01 ; P = 0.01 ) , helplessness/hopelessness ( F [ 1,89 ] = 4.75 ; P = 0.03 ) , and cognitive avoidance ( F [ 1,89 ] = 4.95 ; P = 0.03 ) than those in the control ( information booklet ) group . However , women in the workbook group had significantly poorer body image than those in the control group ( F [ 1,89 ] = 6.43 ; P = 0.01 ) . At 6 months , only the body image interaction remained significant ( F [ 1,93 ] = 7.44 ; P = 0.01 ) . CONCLUSION These results suggest that a self-help workbook can be an effective , short-term intervention for improving posttraumatic stress , cognitive avoidance , and certain depressive symptoms in women recently diagnosed with breast cancer . However , issues related to body image need to be dealt with differently . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Background Among glioma patients , depression is estimated to be more prevalent than in both the general population and the cancer patient population . This can have negative consequences for both patients and their primary informal caregivers ( e.g. , a spouse , family member or close friend ) . At present , there is no evidence from r and omized controlled trials for the effectiveness of psychological treatment for depression in glioma patients . Furthermore , the possibility of delivering mental health care through the internet has not yet been explored in this population . Therefore , a r and omized controlled trial is warranted to evaluate the effects of an internet-based , guided self-help intervention for depressive symptoms in glioma patients . Methods / design The intervention is based on problem-solving therapy . An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms ( Center for Epidemiology Studies Depression Scale score ≥12 ) . Sample size calculations yield 126 glioma patients to be included , who are r and omly assigned to either the intervention group or a waiting list control group .  In addition , we aim to include 63 patients with haematological cancer in a non- central nervous system malignancy control group . Assessment s take place at baseline , after 6 and 12 weeks , and after 6 and 12 months . Primary outcome measure is the change in depressive symptoms . Secondary outcome measures include health-related quality of life , fatigue , costs and patient satisfaction . In addition , all patients are asked to assign a primary informal caregiver , who does not participate in the intervention but who is asked to complete similar assessment s. Their mood , health-related quality of life and fatigue is evaluated as well . Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients . If proven effective , this treatment will contribute to the mental health care of glioma patients in clinical practice .Trial registration Netherl and s Trial Register Background : Internet-based methods for provision of psychological support and intervention to cancer survivors hold promise for increasing the public impact of such treatments . Purpose : The goal of this controlled pilot study was to examine the effect and potential mechanisms of action of a self-guided , Internet-based coping-skills training group on quality of life outcomes in women with early-stage breast cancer . Methods : Sixty-two women completed baseline evaluations and were r and omized into either a small online coping group or a waiting-list control condition . Results : No main effects for treatment were observed at the 12-week follow up . However , there was a significant interaction between baseline self-reported health status and treatment , such that women with poorer self-perceived health status showed greater improvement in perceived health over time when assigned to the treatment condition . Linguistic analyses revealed that positive changes across quality of life variables were associated with greater expression of negative emotions such as sadness and anxiety , greater cognitive processing , and lower expression of health-related concerns . Conclusions : These results demonstrate the potential efficacy of self-guided Internet coping groups while highlighting the limitations of such groups Studies show that engaging patients in exercise and /or stress management techniques during hematopoietic cell transplantation ( HCT ) improves quality of life . The Blood and Marrow Transplant Clinical Trials Network tested the efficacy of training patients to engage in self-directed exercise and stress management during HCT . The study r and omized 711 patients at 21 centers to receive 1 of 4 training interventions before HCT : a self-directed exercise program , a self-administered stress management program , both  ,  or neither .  Participants completed self-reported assessment s at enrollment and up to 180 days after HCT . R and omization was stratified by center and transplant type . There were no differences in the primary endpoints of the Physical Component Summary and Mental Component Summary scales of the Medical Outcomes Study Short Form 36 at day + 100 among the groups , based on an intention-to-treat analysis . There also were no differences in overall survival , days of hospitalization through day + 100 post-HCT , or in other patient-reported outcomes , including treatment-related distress , sleep quality , pain , and nausea . Patients r and omized to training in stress management reported more use of those techniques , but patients r and omized to training in exercise did not report more physical activity . Although other studies have reported efficacy of more intensive interventions , brief training in an easy-to-disseminate format for either self-directed exercise or stress management was not effective in our trial PURPOSE / OBJECTIVES To test the effects of a brief psychosocial intervention using CD-ROM ( BPIC ) on psychosocial ( fighting spirit , helplessness or hopelessness , anxiety , and depression ) and behavioral ( self-care behaviors ) outcomes in patients with cancer receiving adjuvant therapy . DESIGN Quasi-experimental . SETTING A comprehensive cancer center in Seoul , South Korea . SAMPLE 71 patients undergoing adjuvant therapy .  METHODS The study participants were assigned to either BPIC or a control group . The experimental group underwent a two-week psychosocial intervention via CD-ROM , booklet , and telephone counseling . MAIN RESEARCH VARIABLES Fighting spirit , helplessness or hopelessness , anxiety , depression , and self-care behaviors . FINDINGS After BPIC , the experimental group showed significantly higher scores than the control group for fighting spirit ( p = 0.005 ) and self-care behaviors ( p < 0.001 ) . However , the groups showed no significant differences in helplessness or hopelessness ( p = 0.42 ) , anxiety ( p = 0.279 ) , and depression ( p = 0.068 ) . CONCLUSIONS BPIC use improved fighting spirit and self-care behaviors in study participants . The results partially support the effectiveness of BPIC for adaptation among patients with cancer receiving adjuvant therapy . IMPLICATION S FOR NURSING A brief psychosocial intervention using multimedia can be used effectively in clinical oncology setting s to accelerate adaptation among patients with cancer in the adjuvant phase Background Approximately 20–30 % of patients with cancer experience a clinical ly relevant level of emotional distress in response to disease and treatment . This in itself is alarming but it is even more problematic because it is often difficult for physicians and nurses to identify cancer patients who experience clinical ly relevant levels of anxiety and depression symptoms . This can result in persistent distress and can cause human suffering as well as costs for individuals and to the community . Methods Applying a multi-disciplinary and design -oriented approach aim ed at attaining new evidence -based knowledge in basic and applied psychosocial oncology , this protocol will evaluate an intervention to be implemented in clinical practice to reduce cancer patient  anxiety and depression . A prospect i ve r and omized design will be used . The overarching goal of the intervention is to promote psychosocial health among patients suffering from cancer by means of self-help programmes delivered via an Internet platform . Another goal is to reduce costs for individuals and society , caused by emotional distress in response to cancer . Following screening to detect levels of patient distress , patients will be r and omized to st and ard care or a stepped care intervention . For patients r and omized to the intervention , step 1 will consist of self-help material , a chat forum where participants will be able to communicate with each other , and a  Frequently Asked Questions  ( FAQ ) section where they can ask questions and get answers from an expert . Patients in the intervention group who still report symptoms of anxiety or depression after access to step 1 will be offered step 2 , which will consist of cognitive behavioral therapy ( CBT ) administered by a personal therapist . The primary end point of the study is patients ’ levels of anxiety and depression , evaluated longitudinally during and after the intervention . Discussion There is a lack of controlled studies of the psychological and behavioral processes involved in this type of intervention for anxiety and depressive disorders . Since anxiety and depressive symptoms are relatively common in patients with cancer and the availability of adequate support efforts is limited , there is a need to develop evidence -based stepped care for patients with cancer , to be delivered via the Internet . Trial registration Clinical Trials.gov Identifier : OBJECTIVE Psychosocial patient care in oncology is no longer limited to the inpatient setting . Outpatient services are in dem and . Internet-based interventions could aid in optimizing service delivery across disciplines . The effectiveness of an Internet-based program for hematologic cancer patients was tested in a r and omized controlled trial under field experimental conditions . METHODS A 4-week cognitive-behavioral program for coping with cancer was offered to hematologic cancer patients online . One hundred eighty-six registrants were r and omly assigned to an intervention group ( n = 105 ) or a waiting list ( n = 81 ) . The outcome measures , ' mental adjustment ' ( MAC ) and ' psychological distress ' ( BSI ) , were assessed at registration and after 4 weeks . Patient satisfaction was assessed ( ZUF-8 ) , and complete-cases and intention-to-treat analyses were performed . RESULTS At registration , the majority of participants displayed clinical ly significant distress ( BSI ) and lacked alternative access concerning psychosocial care . One hundred eleven patients filled out the post question naire at 4 weeks . In contrast to the waiting list , the intervention group displayed a significant increase in fighting spirit ( d = 0.42 ; CI 95 % , 0.04 to 0.80 ) . The effect was confirmed by intention-to-treat analysis ( d = 0.33 ; CI 95 % , 0.04 to 0.62 ) . Otherwise , no effects were observed . Patient satisfaction with the program was high . CONCLUSION The results demonstrate the potential efficacy of Internet-based programs while highlighting their limitations . Future research is needed to clarify and optimize efficacy , taking different program components and patient characteristics into particular consideration Background High rates of anxiety , depression and unmet needs are evident amongst haematological cancer patients undergoing treatment and their Support Persons . Psychosocial distress may be minimised by ensuring that patients are sufficiently involved in decision making , provided with tailored information and adequate preparation for potentially threatening procedures . To date , there are no published studies evaluating interventions design ed to reduce psychosocial distress and unmet needs specifically in patients with haematological cancers and their Support Persons . This study will examine whether access to a web-based information tool and nurse-delivered telephone support reduces depression , anxiety and unmet information needs for haematological cancer patients and their Support Persons . Methods / Design A non-blinded , parallel-group , multi-centre r and omised controlled trial will be conducted to compare the effectiveness of a web-based information tool and nurse-delivered telephone support with usual care .  Participants will be recruited from the haematology inpatient wards of five hospitals in New South Wales , Australia . Patients diagnosed with acute myeloid leukaemia , acute lymphoblastic leukaemia , Burkitt ’s lymphoma , Lymphoblastic lymphoma ( B or T cell ) , or Diffuse Large B-Cell lymphoma and their Support Persons will be eligible to participate . Patients and their Support Persons will be r and omised as dyads . Participants allocated to the intervention will receive access to a tailored web-based tool that provides accurate , up-to- date and personalised information about : cancer and its causes ; treatment options including treatment procedures information ; complementary and alternative medicine ; and available support . Patients and Support Persons will complete self-report measures of anxiety , depression and unmet needs at 2 , 4 , 8 and 12 weeks post-recruitment . Patient and Support Person outcomes will be assessed independently . Discussion This study will assess whether providing information and support using web-based and telephone support address the major psychosocial challenges faced by haematological patients and their Support Persons . The approach , if found to be effective , has potential to improve psychosocial outcomes for haematological and other cancer patients , reduce the complexity and burden of meeting patients ’ psychosocial needs for health care providers with high potential for translation into clinical practice .Trial registration ACTRN12612000720819 Background A cancer diagnosis elicits greater distress than any other medical diagnosis , and yet very few studies have evaluated the efficacy 
    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: OBJECTIVE To evaluate the efficacy of an interactive self-help workbook in reducing distress , and improving quality of life ( QOL ) and coping for women recently diagnosed with breast cancer . DESIGN R and omised controlled trial comparing the use of the workbook and that of an information booklet . PARTICIPANTS AND SETTING 49 women with Stage 0 to II breast cancer diagnosed in the previous month and recruited from 1 February 2007 to 1 February 2008 , in two urban Australian public hospitals . MAIN OUTCOME MEASURES The primary outcome measures were depression , anxiety , and posttraumatic stress . Secondary outcomes included QOL , body image , and the coping styles helplessness/hopelessness , cognitive avoidance and anxious preoccupation . RESULTS After controlling for baseline levels , interactions at 3-month follow-up showed that participants in the workbook group had significantly lower levels of posttraumatic stress ( F[1,89 ] = 7.01 ; P = 0.01 ) , helplessness/hopelessness ( F [ 1,89 ] = 4.75 ; P = 0.03 ) , and cognitive avoidance ( F [ 1,89 ] = 4.95 ; P = 0.03 ) than those in the control ( information booklet ) group . However , women in the workbook group had significantly poorer body image than those in the control group ( F [ 1,89 ] = 6.43 ; P = 0.01 ) . At 6 months , only the body image interaction remained significant ( F [ 1,93 ] = 7.44 ; P = 0.01 ) . CONCLUSION These results suggest that a self-help workbook can be an effective , short-term intervention for improving posttraumatic stress , cognitive avoidance , and certain depressive symptoms in women recently diagnosed with breast cancer . However , issues related to body image need to be dealt with differently . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Background Among glioma patients , depression is estimated to be more prevalent than in both the general population and the cancer patient population . This can have negative consequences for both patients and their primary informal caregivers ( e.g. , a spouse , family member or close friend ) . At present , there is no evidence from r and omized controlled trials for the effectiveness of psychological treatment for depression in glioma patients . Furthermore , the possibility of delivering mental health care through the internet has not yet been explored in this population . Therefore , a r and omized controlled trial is warranted to evaluate the effects of an internet-based , guided self-help intervention for depressive symptoms in glioma patients . Methods / design The intervention is based on problem-solving therapy . An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms ( Center for Epidemiology Studies Depression Scale score ≥12 ) . Sample size calculations yield 126 glioma patients to be included , who are r and omly assigned to either the intervention group or a waiting list control group .  In addition , we aim to include 63 patients with haematological cancer in a non- central nervous system malignancy control group . Assessment s take place at baseline , after 6 and 12 weeks , and after 6 and 12 months . Primary outcome measure is the change in depressive symptoms . Secondary outcome measures include health-related quality of life , fatigue , costs and patient satisfaction . In addition , all patients are asked to assign a primary informal caregiver , who does not participate in the intervention but who is asked to complete similar assessment s. Their mood , health-related quality of life and fatigue is evaluated as well . Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients . If proven effective , this treatment will contribute to the mental health care of glioma patients in clinical practice .Trial registration Netherl and s Trial Register Background : Internet-based methods for provision of psychological support and intervention to cancer survivors hold promise for increasing the public impact of such treatments . Purpose : The goal of this controlled pilot study was to examine the effect and potential mechanisms of action of a self-guided , Internet-based coping-skills training group on quality of life outcomes in women with early-stage breast cancer . Methods : Sixty-two women completed baseline evaluations and were r and omized into either a small online coping group or a waiting-list control condition . Results : No main effects for treatment were observed at the 12-week follow up . However , there was a significant interaction between baseline self-reported health status and treatment , such that women with poorer self-perceived health status showed greater improvement in perceived health over time when assigned to the treatment condition . Linguistic analyses revealed that positive changes across quality of life variables were associated with greater expression of negative emotions such as sadness and anxiety , greater cognitive processing , and lower expression of health-related concerns . Conclusions : These results demonstrate the potential efficacy of self-guided Internet coping groups while highlighting the limitations of such groups Studies show that engaging patients in exercise and /or stress management techniques during hematopoietic cell transplantation ( HCT ) improves quality of life . The Blood and Marrow Transplant Clinical Trials Network tested the efficacy of training patients to engage in self-directed exercise and stress management during HCT . The study r and omized 711 patients at 21 centers to receive 1 of 4 training interventions before HCT : a self-directed exercise program , a self-administered stress management program , both  ,  or neither .  Participants completed self-reported assessment s at enrollment and up to 180 days after HCT . R and omization was stratified by center and transplant type . There were no differences in the primary endpoints of the Physical Component Summary and Mental Component Summary scales of the Medical Outcomes Study Short Form 36 at day + 100 among the groups , based on an intention-to-treat analysis . There also were no differences in overall survival , days of hospitalization through day + 100 post-HCT , or in other patient-reported outcomes , including treatment-related distress , sleep quality , pain , and nausea . Patients r and omized to training in stress management reported more use of those techniques , but patients r and omized to training in exercise did not report more physical activity . Although other studies have reported efficacy of more intensive interventions , brief training in an easy-to-disseminate format for either self-directed exercise or stress management was not effective in our trial PURPOSE / OBJECTIVES To test the effects of a brief psychosocial intervention using CD-ROM ( BPIC ) on psychosocial ( fighting spirit , helplessness or hopelessness , anxiety , and depression ) and behavioral ( self-care behaviors ) outcomes in patients with cancer receiving adjuvant therapy . DESIGN Quasi-experimental . SETTING A comprehensive cancer center in Seoul , South Korea . SAMPLE 71 patients undergoing adjuvant therapy .  METHODS The study participants were assigned to either BPIC or a control group . The experimental group underwent a two-week psychosocial intervention via CD-ROM , booklet , and telephone counseling . MAIN RESEARCH VARIABLES Fighting spirit , helplessness or hopelessness , anxiety , depression , and self-care behaviors . FINDINGS After BPIC , the experimental group showed significantly higher scores than the control group for fighting spirit ( p = 0.005 ) and self-care behaviors ( p < 0.001 ) . However , the groups showed no significant differences in helplessness or hopelessness ( p = 0.42 ) , anxiety ( p = 0.279 ) , and depression ( p = 0.068 ) . CONCLUSIONS BPIC use improved fighting spirit and self-care behaviors in study participants . The results partially support the effectiveness of BPIC for adaptation among patients with cancer receiving adjuvant therapy . IMPLICATION S FOR NURSING A brief psychosocial intervention using multimedia can be used effectively in clinical oncology setting s to accelerate adaptation among patients with cancer in the adjuvant phase Background Approximately 20–30 % of patients with cancer experience a clinical ly relevant level of emotional distress in response to disease and treatment . This in itself is alarming but it is even more problematic because it is often difficult for physicians and nurses to identify cancer patients who experience clinical ly relevant levels of anxiety and depression symptoms . This can result in persistent distress and can cause human suffering as well as costs for individuals and to the community . Methods Applying a multi-disciplinary and design -oriented approach aim ed at attaining new evidence -based knowledge in basic and applied psychosocial oncology , this protocol will evaluate an intervention to be implemented in clinical practice to reduce cancer patient  anxiety and depression . A prospect i ve r and omized design will be used . The overarching goal of the intervention is to promote psychosocial health among patients suffering from cancer by means of self-help programmes delivered via an Internet platform . Another goal is to reduce costs for individuals and society , caused by emotional distress in response to cancer . Following screening to detect levels of patient distress , patients will be r and omized to st and ard care or a stepped care intervention . For patients r and omized to the intervention , step 1 will consist of self-help material , a chat forum where participants will be able to communicate with each other , and a  Frequently Asked Questions  ( FAQ ) section where they can ask questions and get answers from an expert . Patients in the intervention group who still report symptoms of anxiety or depression after access to step 1 will be offered step 2 , which will consist of cognitive behavioral therapy ( CBT ) administered by a personal therapist . The primary end point of the study is patients ’ levels of anxiety and depression , evaluated longitudinally during and after the intervention . Discussion There is a lack of controlled studies of the psychological and behavioral processes involved in this type of intervention for anxiety and depressive disorders . Since anxiety and depressive symptoms are relatively common in patients with cancer and the availability of adequate support efforts is limited , there is a need to develop evidence -based stepped care for patients with cancer , to be delivered via the Internet . Trial registration Clinical Trials.gov Identifier : OBJECTIVE Psychosocial patient care in oncology is no longer limited to the inpatient setting . Outpatient services are in dem and . Internet-based interventions could aid in optimizing service delivery across disciplines . The effectiveness of an Internet-based program for hematologic cancer patients was tested in a r and omized controlled trial under field experimental conditions . METHODS A 4-week cognitive-behavioral program for coping with cancer was offered to hematologic cancer patients online . One hundred eighty-six registrants were r and omly assigned to an intervention group ( n = 105 ) or a waiting list ( n = 81 ) . The outcome measures , ' mental adjustment ' ( MAC ) and ' psychological distress ' ( BSI ) , were assessed at registration and after 4 weeks . Patient satisfaction was assessed ( ZUF-8 ) , and complete-cases and intention-to-treat analyses were performed . RESULTS At registration , the majority of participants displayed clinical ly significant distress ( BSI ) and lacked alternative access concerning psychosocial care . One hundred eleven patients filled out the post question naire at 4 weeks . In contrast to the waiting list , the intervention group displayed a significant increase in fighting spirit ( d = 0.42 ; CI 95 % , 0.04 to 0.80 ) . The effect was confirmed by intention-to-treat analysis ( d = 0.33 ; CI 95 % , 0.04 to 0.62 ) . Otherwise , no effects were observed . Patient satisfaction with the program was high . CONCLUSION The results demonstrate the potential efficacy of Internet-based programs while highlighting their limitations . Future research is needed to clarify and optimize efficacy , taking different program components and patient characteristics into particular consideration Background High rates of anxiety , depression and unmet needs are evident amongst haematological cancer patients undergoing treatment and their Support Persons . Psychosocial distress may be minimised by ensuring that patients are sufficiently involved in decision making , provided with tailored information and adequate preparation for potentially threatening procedures . To date , there are no published studies evaluating interventions design ed to reduce psychosocial distress and unmet needs specifically in patients with haematological cancers and their Support Persons . This study will examine whether access to a web-based information tool and nurse-delivered telephone support reduces depression , anxiety and unmet information needs for haematological cancer patients and their Support Persons . Methods / Design A non-blinded , parallel-group , multi-centre r and omised controlled trial will be conducted to compare the effectiveness of a web-based information tool and nurse-delivered telephone support with usual care .  Participants will be recruited from the haematology inpatient wards of five hospitals in New South Wales , Australia . Patients diagnosed with acute myeloid leukaemia , acute lymphoblastic leukaemia , Burkitt ’s lymphoma , Lymphoblastic lymphoma ( B or T cell ) , or Diffuse Large B-Cell lymphoma and their Support Persons will be eligible to participate . Patients and their Support Persons will be r and omised as dyads . Participants allocated to the intervention will receive access to a tailored web-based tool that provides accurate , up-to- date and personalised information about : cancer and its causes ; treatment options including treatment procedures information ; complementary and alternative medicine ; and available support . Patients and Support Persons will complete self-report measures of anxiety , depression and unmet needs at 2 , 4 , 8 and 12 weeks post-recruitment . Patient and Support Person outcomes will be assessed independently . Discussion This study will assess whether providing information and support using web-based and telephone support address the major psychosocial challenges faced by haematological patients and their Support Persons . The approach , if found to be effective , has potential to improve psychosocial outcomes for haematological and other cancer patients , reduce the complexity and burden of meeting patients ’ psychosocial needs for health care providers with high potential for translation into clinical practice .Trial registration ACTRN12612000720819 Background A cancer diagnosis elicits greater distress than any other medical diagnosis , and yet very few studies have evaluated the efficacy 
    Output:
    