Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: the TREND statement. Measurement of health status. Ascertaining the minimal clinically important difference. Struggling with cancer and treatment: young athletes recapture body control and identity through exercise: qualitative findings from a supervised group exercise program in cancer patients of mixed gender undergoing chemotherapy. Fertility of female survivors of childhood cancer: a report from the childhood cancer survivor study. Effects of an exercise intervention on bone mass in pediatric bone tumor patients. Exercise Interventions in Children with Cancer: A Review The group matters: an explorative study of group cohesion and quality of life in cancer patients participating in physical exercise intervention during treatment. Effectiveness of physical activity on cardiorespiratory fitness and health-related quality of life in young and middle-aged cancer patients shortly after chemotherapy. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Randomized controlled trial of the effects of aerobic exercise on physical functioning and quality of life in lymphoma patients. Implementation of structured physical activity in the pediatric stem cell transplantation. Improved physical fitness of cancer survivors: A randomised controlled trial comparing physical training with physical and cognitive-behavioural training Clinical field testing of an enhanced-activity intervention in hospitalized children with cancer. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials The effects of a six-week supervised multimodal exercise intervention during chemotherapy on cancer-related fatigue. Effects of a 12-Month Randomized Controlled Trial of Aerobic or Resistance Exercise During and Following Cancer Treatment in Women
Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Cancer and treatment can negatively affect the body 's performance and appearance .  Exercise has been tested in a few studies for altered body image among middle-aged women with breast cancer . The aim of the study was to explore how young pre-cancer athletes of both genders experience disease- and treatment-related physical fitness and appearance changes while undergoing chemotherapy and participating in a 6-week group exercise intervention . A prospect i ve , explorative study using semi-structured interviews was conducted before and at termination of the intervention . The study included 22 cancer patients ( median age 28 years ) . The young athletes experienced a change from a high level of physical activity , body satisfaction and a positive self-identity to a low level of physical activity , body denial and a negative self-identity . In the program , the patients experienced increased physical strength and recapture of certain aspects of their former positive body perception . Deterioation of muscle functions caused by chemotherapy was particularly painful to these patients , independent of gender and age . Young physically active patients are heavily dependent on their physical capacity , body satisfaction and self-identity . This should be taken into account when design ing programs to rehabilitate and encourage these patients through the often-strenuous antineoplastic treatments PURPOSE This study was undertaken to determine the effect , if any , of treatment for cancer diagnosed during childhood or adolescence on fertility . PATIENTS AND METHODS We review ed the fertility of female participants in the Childhood Cancer Survivor Study ( CCSS ) , which consisted of 5-year survivors , and a cohort of r and omly selected siblings who responded to a question naire . Medical records of all members of the cohort were abstract ed to obtain chemotherapeutic agents administered ; the cumulative dose of drug administered for several drugs of interest ; and the doses , volumes , and date s of administration of all radiation therapy . RESULTS There were 5,149 female CCSS participants , and there were 1,441 female siblings of CCSS participants who were age 15 to 44 years . The relative risk ( RR ) for survivors of ever being pregnant was 0.81 ( 95 % CI , 0.73 to 0.90 ; P < .001 ) compared with female siblings . In multivariate models among survivors only , those who received a hypothalamic/pituitary radiation dose > or = 30 Gy ( RR , 0.61 ; 95 % CI , 0.44 to 0.83 ) or an ovarian/uterine radiation dose greater than 5 Gy were less likely to have ever been pregnant ( RR , 0.56 for 5 to 10 Gy ; 95 % CI , 0.37 to 0.85 ; RR , 0.18 for > 10 Gy ; 95 % CI , 0.13 to 0.26 ) . Those with a summed alkylating agent dose ( AAD ) score of three or four or who were treated with lomustine or cyclophosphamide were less likely to have ever been pregnant . CONCLUSION This large study demonstrated that fertility is decreased among female CCSS participants . The risk factors identified may be utilized for pretreatment counseling of patients and their parents The aim was to evaluate the effects of additional exercises during inpatient stays on bone mass in pediatric bone tumor patients . 21 patients were non-r and omly allocated either to the  exercise group ( n = 10 ) or the control group ( n = 11 ) . DXA of the lumbar spine , the non-affected femur and both calcanei was performed after completion of neoadjuvant chemotherapy ( baseline ) , as well as 6 and 12 months after baseline . Bone mineral content ( BMC ) , bone mineral density ( BMD ) and height-corrected lumbar spine Z-scores were determined . Group changes after 6 and 12 months were compared by covariance analyses . Additionally ,  daily physical activities ( PA )  were assessed by means of accelerometry . After adjusting for initial age , height and weight , mean reductions in lumbar spine and femoral BMC were lower in the exercise group ( not significant ) . Effect sizes during the observational period for lumbar spine and femur BMC were generally small ( partial η² = 0.03 ) . The exercise group demonstrated substantially higher PA levels in terms of gait cycles per day , per hour and moderate PA ( activities above 40 gait cycles per minute ) . Additional exercises for bone tumor patients are feasible during hospitalization . Though the intervention did not influence BMC , it appeared beneficial regarding PA promotion with respect to volume and intensity The purpose of this review is to summarize literature that describes the impact of exercise on health and physical function among children during and after treatment for cancer . Relevant studies were identified by entering the following search terms into Pubmed : aerobic training ; resistance training ; stretching ; pediatric ; children ; AND cancer . Reference lists in retrieved manuscripts were also review ed to identify additional trials . We include fifteen intervention trials published between 1993 and 2011 that included children younger than age 21 years with cancer diagnoses . Nine included children with an acute lymphoblastic leukemia ( ALL ) diagnosis , and six children with mixed cancer diagnoses . Generally , interventions tested were either in-hospital supervised exercise training or home based programs design ed to promote physical activity . Early evidence from small studies indicates that the effects of exercise include increased cardiopulmonary fitness , improved muscle strength and flexibility , reduced fatigue and improved physical function . Generalizations to the entire childhood cancer and childhood cancer survivor population s are difficult as most of the work has been done in children during treatment for and among survivors of ALL . Additional r and omized studies are needed to confirm these benefits in larger population s of children with ALL , and in population s with cancer diagnoses other than ALL A series of studies have shown that physical activity improves cancer patients  functional capacity and quality of life ( QOL ) . Few of these studies have included physical exercise carried out in a group setting . However , patient 's experience with the in-group processes remains unexplored . This study investigated group cohesion and changes in QOL in 55 cancer patients undergoing chemotherapy who participated in a 9 h weekly group exercise programme for 6 weeks . The study used a method triangulation component design . Seven qualitative group interviews were conducted post-intervention . QOL ( SF-36 ; EORTC QLQ-C30 ) was assessed at baseline and after Week 6 . The interviews revealed that group cohesion was an interim goal aim ed to maximize peak performance potential by patients . Group cohesion was characterized by a special ' esprit de corps ' and enabled the group members to feel like sport teams . The programme made purpose ful togetherness possible while allowing the patients an opportunity to let their illness fade into the background . Question naire data showed significant improvements in mental health , social and emotional functioning . This study identified a conceptualization of group cohesion that forms a valuable basis for a larger r and omized controlled trial to conclude whether the observed changes are a result of this specific intervention PURPOSE To evaluate the effectiveness of a supervised home-based flexible training program on cardiorespiratory fitness ( CRF ) , mental distress , and health-related quality of life ( HRQOL ) parameters in young and middle-aged cancer patients shortly after curative chemotherapy . PATIENTS AND METHODS One hundred eleven patients age 18 to 50 years who had received chemotherapy for lymphomas or breast , gynecologic , or testicular cancer completed the trial . These patients were r and omly allocated to either an intervention group ( n = 59 ) , which underwent a 14-week training program , or a control group ( n = 52 ) that received st and ard care . Primary outcome was change in CRF , as determined by Astr and -Rhyming indirect bicycle ergometer test ( maximum oxygen uptake [ VO(2max ) ] ) , between baseline ( T0 ) and follow-up ( T1 ) . Secondary outcomes were mental distress , as assessed by the Hospital Anxiety and Depression Scale , and HRQOL , as assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Question naire . Two-way analysis of covariance was used to analyze changes from T0 to T1 . RESULTS VO(2max ) increased by 6.4 mL/kg(-1)/min(-1 ) in patients in the intervention group and by 3.1 mL/kg(-1)/min(-1 ) in patients in the control group ( P < .01 ) . The fatigue score decreased by 17.0 points in the control group compared with only 5.8 points in the intervention group ( P < .01 ) . There were no intergroup differences in mental distress or HRQOL . CONCLUSION A supervised , home-based , flexible training program has significant effect on CRF in young and middle-aged cancer patients shortly after curative chemotherapy , but it has no favorable effect on patients ' experience of fatigue , mental distress , or HRQOL BACKGROUND Children with acute lymphoblastic leukemia ( ALL ) are at risk for developing musculoskeletal complications during and after their medical treatment . The objective of this study was to examine the feasibility of an in-hospital physical therapy- and home exercise program during the first four phases of medical treatment , for children with newly diagnosed ALL . PROCEDURE Nine patients , between the ages of 2 - 14 years old were enrolled within 2 weeks of diagnosis in the study . Each patient was evaluated at study entry , after each of the first four phases of therapy and each time patients were re-admitted to the hospital . Following the initial physical therapy evaluation an individualized home exercise program was developed , consisting of stretching , strengthening , and aerobic exercises . The following end points were measured at each evaluation : gross motor assessment as measured by gross motor function measure ( GMFM ) , health-related quality of life as measured by the PedsQL and parent satisfaction question naire . RESULTS This study was feasible with 98 % of the evaluation sessions completed . The GMFM and PedsQL improved steadily throughout the study ; however , the PedsQL slightly decreased from interim maintenance to delayed intensification . The parents reported being satisfied with the physical therapy program . CONCLUSION We demonstrated that an in-hospital- and home exercise physical therapy program during the first four phases of medical treatments is feasible for children with ALL . Future r and omized studies are needed to confirm whether an initial physical therapy program at diagnosis in children with ALL will limit functional impairments , improve overall fitness and increase health-related quality of life PURPOSE Lymphoma patients commonly experience declines in physical functioning and quality of life ( QoL )  that may be reversed with exercise training . PATIENTS AND METHODS We conducted a r and omized controlled trial in Edmonton , Alberta , Canada , between 2005 and 2008 that stratified 122 lymphoma patients by major disease type and current treatment status and r and omly assigned them to usual care ( UC ; n = 62 ) or 12 weeks of supervised aerobic exercise training ( AET ; n = 60 ) . Our primary end point was patient-rated physical functioning assessed by the Trial Outcome Index-Anemia . Secondary end points were overall QoL , psychosocial functioning , cardiovascular fitness , and body composition . RESULTS Follow-up assessment for our primary end point was 96 % ( 117 of 122 ) at postintervention and 90 % ( 110 of 122 ) at 6-month follow-up . Median adherence to the supervised exercise program was 92 % . At postintervention , AET was superior to UC for patient-rated physical functioning ( mean group difference , + 9.0 ; 95 % CI , 2.0 to 16.0 ; P = .012 ) , overall QoL ( P = .021 ) , fatigue ( P = .013 ) , happiness ( P = .004 ) , depression ( P = .005 ) , general health ( P < .001 ) , cardiovascular fitness ( P < .001 ) , and lean body mass ( P = .008 ) . Change in peak cardiovascular fitness mediated the change in patient-rated physical functioning . AET did not interfere with chemotherapy completion rate or treatment response . At 6-month follow-up , AET was still borderline or significantly superior to UC for overall QoL ( P = .054 ) , happiness ( P = .034 ) , and depression ( P = .009 ) without an increased risk of disease recurrence/progression . CONCLUSION AET significantly improved important patient-rated outcomes and objective physical functioning in lymphoma patients without interfering with medical treatments or response . Exercise training to improve cardiovascular fitness should be considered in the management of lymphoma patients The peripheral blood stem cell transplantation ( PBSCT ) represents a specific , but stressful therapy for hemato-oncological diseases . While for adults , data suggest positive eff ects for a supportive sport therapy , this question is not evaluated sufficiently for children . The objective of this study was to examine the integration of sports activity into pediatric PBSCT and to indicate attainable results . This 2-step case-control- study included 23 children and adolescents from the PBSCT : During the isolation phase 13 patients trained 3 times per week on a cycle ergometer and passed a course with different sports equipment . Apart from recording physiologic adaptations , quality of live was inquired in a pre-post design using question naires . Guided interviews according to necessity and requirements for sports activity at the PBSCT unit completed the evaluation and were used for the intervention as well as for the control group ( n = 10 ) without sports therapy . On the ergometer , patients trained average 25 min with 0.6 watt / kg . In the majority , a loss of muscular power could be avoided . Quality of life and fatigue symptoms improved by trend . Interview analysis showed general acceptance of physical activity during PBSCT . After initial skepticism due to the additional burden , our implementation study showed the feasibility of  supportive sports therapy  in PBSCT . Quality and flexibility of the equipment should be higher than normal and different physical and psychological conditions of the patients should be anticipated and integrated into the training program We compared the effect of a group-based 12-week supervised exercise programme , i.e. aerobic and resistance exercise , and group sports , with that of the same programme combined with cognitive-behavioural training on physical fitness and activity of cancer survivors . One hundred and forty seven cancer survivors ( all cancer types , medical treatment ≥3 months ago ) were r and omly assigned to physical training ( PT , n=71 ) or PT plus cognitive-behavioural training ( PT+CBT , n=76 ) . Maximal aerobic capacity , muscle strength and physical activity were assessed at baseline and post-intervention . Analyses using multilevel linear mixed-effects models showed that cancer survivors ’ physical fitness increased significantly in PT and PT+CBT from baseline to post-intervention . Changes did not differ between PT and PT+CBT . Physical fitness of cancer survivors was improved following an intensive physical training programme . Adding a structured cognitive-behavioural intervention did not enhance the effect This prospect i ve , two-site , r and omized , controlled pilot study assessed the feasibility of an enhanced physical activity ( EPA ) intervention in hospitalized children and adolescents receiving treatment for a solid tumor or for acute myeloid leukemia ( AML ) , and assessed different statistical techniques to detect the intervention 's sleep and fatigue outcomes .  Twenty-nine patients ( 25 with a solid tumor and 4 with AML ) participated . Data were collected from actigraph ; patient , parent , and staff nurse reports of patient fatigue ; parent sleep diaries ; and patient charts . The intervention was successfully implemented 85.4 % of the scheduled times . We used two different statistical methods to analyze the longitudinal data . Using an ANOVA model , sleep was significantly more efficient in the experimental arm than in the control arm when daily differences from baseline sleep efficiency values were averaged and compared ( F=4.17 , P=0.053 ) . However , in a mixed model ( repeated measures ) analysis , sleep duration ( F=0.54 , P=0.47 ) and sleep efficiency ( F=0.04 , P=0.85 ) were not seen to differ between study arms . We conclude that an inpatient intervention of EPA can be delivered to children and adolescents receiving chemotherapy . Our findings identify design and statistical considerations for a future effectiveness study of the EPA intervention in hospitalized pediatric oncology patients Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials PURPOSE Cancer related fatigue ( CRF ) is a common problem for cancer patients across diagnoses during chemotherapy  and is associated with physical inactivity , lower functional level and lack of energy . Few RCT exercise intervention studies have included cancer patients undergoing chemotherapy . The objective of this study is to evaluate whether a six-week supervised multimodal exercise intervention , adjunct to chemotherapy and st and ard care , can reduce the patient 's CRF level . METHODS Data is based on analyses of a prospect i ve r and omised controlled trial ' The Body & Cancer Trial ' . 213 cancer patients with different diagnoses were r and omised into an intervention group or wait-list control group . The primary outcome , Fatigue score ( CRF ) , was evaluated by the Functional Assessment of Cancer Therapy-Anaemia Question naire ( FACT-An- ) ( FACT-G score & FACT-An Anemia subscale ) . INTERVENTION Supervised exercise , comprising high-intensity cardiovascular and heavy resistance training , relaxation- and body awareness training and massage , 9 h weekly for 6 weeks . RESULTS CRF was significantly reduced in the intervention group , corresponding to a Fatigue score reduction of 3.04 ( effect size of 0.44 , 95 % CI 0.17 - 0.72 ) ( P = .002 ) , the FACT-An score by 5.40 ( P = .015 ) , the FACT-An Toi score by 5.22 ( P = .009 ) and the Anaemia-ANS by 3.76 ( P = .002 ) . There was no statistically significant effect on the General Quality of Life score ( FACT-G ) or on any of the individual wellbeing scores ; Physical ( P = .13 ) , Emotional ( P = .87 ) , Social ( P = .83 ) and Functional ( P = .26 ) . CONCLUSION In summary , this six-week supervised multimodal exercise intervention can lead to significant reduction in self-reported CRF in cancer patients undergoing chemotherapy Abstract Weight gain is common during and following cancer treatment and contributes to many adverse health consequences and increased risk of recurrence for cancer survivors . The purpose of this longitudinal r and omized controlled trial was to compare differences in weight change and body composition among newly diagnosed cancer survivors receiving chemotherapy who were r and omly assigned to usual care control , aerobic exercise , or resistance exercise interventions .  It was hypothesized that cancer survivors become more sedentary during treatment , leading to positive energy balance that in turn worsens body composition . One hundred one subjects completed the 12-month study . Data collected included body composition ( body weight and dual energy x-ray absorptiometry scan ) , aerobic capacity ( 12-minute walk ) , and muscle strength ( 1 repetition maximum ) . Aerobic exercisers were found to have significant improvements in body composition , aerobic capacity , and muscle strength . Resistance exercisers also benefitted , but were less compliant with the intervention over time . Thus , exercise during and following cancer treatment is an important intervention to maintain and perhaps improve body composition of cancer survivors , which may improve survival , reduce comorbidities , and improve quality of life
BACKGROUND There are numerous published controlled trials assessing the safety and the benefits of physical activity ( PA ) for child and adult cancer survivors .
However , trials exclusively comprised of adolescent cancer survivors aged 13 - 19 years , who may experience different health and quality of life ( QOL ) effects as a function of their developmental status , are lacking .
Rather , some trials have included both adolescent and child cancer survivors together .
OBJECTIVE The aim of this systematic review was to synthesize the findings from r and omized controlled trails ( RCTs ) and controlled clinical trials ( CCTs ) investigating the effects of PA on health and QOL outcomes in sample s comprised of > 50 % adolescent cancer survivors to summarize the current state of evidence , identify knowledge gaps , and highlight areas in need of additional research within this population .