Exercise during chemotherapy for ovarian cancer (ECHO) trial : design and implementation of a randomised controlled trial

Introduction Epidemiological evidence supports an association between higher levels of physical activity and improved cancer survival. Trial evidence is now needed to demonstrate the effect of exercise in a clinical setting. The Exercise during CHemotherapy for Ovarian cancer (ECHO) trial is a phase III, randomised controlled trial, designed to determine the effect of exercise on progression-free survival and physical well-being for patients receiving first-line chemotherapy for ovarian cancer. Methods and analysis Participants (target sample size n=500) include women with newly diagnosed primary ovarian cancer, scheduled to receive first-line chemotherapy. Consenting participants are randomly allocated (1:1) to either the exercise intervention (plus usual care) or usual care alone, with stratification for recruitment site, age, stage of disease and chemotherapy delivery (neoadjuvant vs adjuvant). The exercise intervention involves individualised exercise prescription with a weekly target of 150 minutes of moderate-intensity, mixed-mode exercise (equivalent to 450 metabolic equivalent minutes per week), delivered for the duration of first-line chemotherapy through weekly telephone sessions with a trial-trained exercise professional. The primary outcomes are progression-free survival and physical well-being. Secondary outcomes include overall survival, physical function, body composition, quality of life, fatigue, sleep, lymphoedema, anxiety, depression, chemotherapy completion rate, chemotherapy-related adverse events, physical activity levels and healthcare usage. Ethics and dissemination Ethics approval for the ECHO trial (2019/ETH08923) was granted by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Zone) on 21 November 2014. Subsequent approvals were granted for an additional 11 sites across Queensland, New South Wales, Victoria and the Australian Capital Territory. Findings from the ECHO trial are planned to be disseminated via peer-reviewed publications and international exercise and oncology conferences

The Cost of Acute Respiratory Infections With Cough Among Urban Aboriginal and Torres Strait Islander Children

Introduction: Acute respiratory infections with cough (ARIwC) contribute considerably to childhood morbidity, yet few studies have examined the cost of these illnesses among Australian children. Moreover, of the few studies that have, none are inclusive of Aboriginal and/or Torres Strait Islander children, despite this population experiencing a greater burden of respiratory illnesses. This study aimed to determine the costs of ARIwC among urban Aboriginal and/or Torres Strait Islander children from the perspective of caretakers, the public healthcare system, and employers.Methods: This cost of illness study used data collected from Aboriginal and/or Torres Strait Islander children aged <5 years enrolled in a 12 month prospective cohort study conducted through an urban primary healthcare clinic in Queensland, Australia. Illness-related resource use was collected for each episode of ARIwC reported, and costed at market rates. Linear regression was used to (a) examine cost per episode by season of illness onset and cough duration and (b) examine cost per month of observation by baseline child and family characteristics.Results: During the study period, a total of 264 episodes of ARIwC were reported among 138 children. The total mean cost was estimated to be $AU252 per non-hospitalized episode (95$991 (95%CI 514–1468). Winter episodes and episodes resulting in chronic cough were associated with significantly higher costs per episode. A prior history of wheezing, connections to traditional lands and parent/guardian belief that antibiotics should be given until symptoms resolved were associated with significantly higher cost per child month of observation.Conclusion: The cost of ARIwC in this predominantly disadvantaged population is substantial, particularly for caretakers and this needs to be considered in both clinical management and public health initiatives. The importance of cultural factors on health and burden of illness should not be overlooked. Further research into the prevention of chronic cough may play an important role in reducing the economic burden of pediatric respiratory infections

A cost-consequences analysis of the SAFE trial: a comparative, effectiveness trial evaluating high- versus low-supervision of an exercise intervention for women with breast cancer

Purpose: The aim of this analysis was to compare the cost-consequences of a 12 week exercise intervention when delivered under high- versus low-level supervision conditions by an Exercise Professional (ExP) to women with breast cancer. Methods: 60 women (50 ± 9 years) with stage II + breast cancer, who were insufficiently active, and reported ≥ 1 comorbidities or persistent treatment-related side-effects, were randomized to the high- or low-supervision group. The high-supervision group received 20 supervised sessions with an ExP over a 12 week period (reflecting a typical research model), whereas the low-supervision group received five sessions over the same period (replicating what is publicly funded within Australia). Health outcomes including health-related quality of life, and physical and psychosocial outcomes were assessed at baseline and post-intervention. To assess intervention consequences, composite effectiveness scores were created by calculating mean z-scores from raw data for all outcomes per participant. Total program costs were calculated including program development, staff training, program implementation, and equipment. Results: 79.3% of the high- and 63.0% of the low-supervision group showed clinically relevant health improvements. Cost per improver was $1,814 for 23 improvers and$1,571 for 17 improvers in the high- and low-supervision groups, respectively. Conclusion: The SAFE exercise intervention, when delivered via high- or low-supervised conditions, represents good value with over 60% of women in both groups reporting health improvements. High-supervision levels resulted in a greater proportion of women experiencing health benefits, but future research will need to determine the longer term health impacts of these group differences.</p

[In Press] A cost‑consequences analysis of the SAFE trial : a comparative, effectiveness trial evaluating high‑ versus low‑supervision of an exercise intervention for women with breast cancer

Purpose The aim of this analysis was to compare the cost-consequences of a 12 week exercise intervention when delivered under high- versus low-level supervision conditions by an Exercise Professional (ExP) to women with breast cancer. Methods 60 women (50 ± 9 years) with stage II + breast cancer, who were insufficiently active, and reported ≥ 1 comorbidities or persistent treatment-related side-effects, were randomized to the high- or low-supervision group. The high-supervision group received 20 supervised sessions with an ExP over a 12 week period (reflecting a typical research model), whereas the low-supervision group received five sessions over the same period (replicating what is publicly funded within Australia). Health outcomes including health-related quality of life, and physical and psychosocial outcomes were assessed at baseline and post-intervention. To assess intervention consequences, composite effectiveness scores were created by calculating mean z-scores from raw data for all outcomes per participant. Total program costs were calculated including program development, staff training, program implementation, and equipment. Results 79.3% of the high- and 63.0% of the low-supervision group showed clinically relevant health improvements. Cost per improver was $1,814 for 23 improvers and$1,571 for 17 improvers in the high- and low-supervision groups, respectively. Conclusion The SAFE exercise intervention, when delivered via high- or low-supervised conditions, represents good value with over 60% of women in both groups reporting health improvements. High-supervision levels resulted in a greater proportion of women experiencing health benefits, but future research will need to determine the longer term health impacts of these group differences

Longitudinal study of quality of life among children with acute respiratory infection and cough

Acute respiratory infections (ARIs), and associated symptoms such as cough, are frequently experienced among children and impose a burden on families (e.g., use of medical resources and time off work/school). However, there are little data on changes in, and predictors of, quality of life (QoL) over the duration of an ARI with cough (ARIwC) episode. We therefore aimed to determine cough-specific QoL and identify its influencing factors among children with ARIwC, at the time of presentation to a pediatric emergency department (ED), and over the following 4 weeks.Data from 283 children aged

The Cost of Acute Respiratory Infections With Cough Among Urban Aboriginal and Torres Strait Islander Children

Introduction: Acute respiratory infections with cough (ARIwC) contribute considerably to childhood morbidity, yet few studies have examined the cost of these illnesses among Australian children. Moreover, of the few studies that have, none are inclusive of Aboriginal and/or Torres Strait Islander children, despite this population experiencing a greater burden of respiratory illnesses. This study aimed to determine the costs of ARIwC among urban Aboriginal and/or Torres Strait Islander children from the perspective of caretakers, the public healthcare system and employers. Methods: This cost of illness study used data collected from Aboriginal and/or Torres Strait Islander children aged Results: During the study period, a total of 264 episodes of ARIwC were reported among 138 children. The total mean cost was estimated to be $AU252 per non-hospitalized episode (95$991 (95%CI 514-1468). Winter episodes and episodes resulting in chronic cough were associated with significantly higher costs per episode. A prior history of wheezing, connections to traditional lands and parent/guardian belief that antibiotics should be given until symptoms resolved were associated with significantly higher cost per child month of observation. Conclusion: The cost of ARIwC in this predominantly disadvantaged population is substantial, particularly for caretakers and this needs to be considered in both clinical management and public health initiatives. The importance of cultural factors on health and burden of illness should not be overlooked. Further research into the prevention of chronic cough may play an important role in reducing the economic burden of pediatric respiratory infection

Pre-post feasibility trial of a telephone-delivered exercise intervention for patients during chemotherapy for recurrent ovarian cancer: the ECHO-R trial protocol

Introduction The benefits of exercise in reducing treatment-related morbidity and improving quality of life following a primary diagnosis of cancer have been well documented and have led to exercise being recommended by oncology societies for all people with a cancer diagnosis. However, these recommendations are derived from research typically involving cohorts with more common cancers and relatively good prognosis, such as breast and prostate. Evidence from these cancers may not apply to women with recurrent ovarian cancer. Therefore, the primary objective of this trial is to evaluate the feasibility and safety of a home-based, telephone-delivered exercise intervention for women undergoing chemotherapy for recurrent ovarian cancer.Methods and analysis The Exercise During Chemotherapy for Recurrent Ovarian Cancer (ECHO-R) trial is a single-arm, phase II, pre/postintervention trial of a 6-month, telephone-delivered exercise intervention (consistent with recommended exercise oncology prescription). The target sample size is 80 women who are currently undergoing (or are scheduled to receive) chemotherapy for recurrent ovarian cancer. Recruitment is through participating hospital sites in Queensland, Australia, or via self-referral. The exercise intervention comprises 12 telephone sessions over a 6-month period delivered by trial-trained exercise professionals and supplemented (where feasible) by five sessions face to face. Exercise prescription is individualised and works towards an overall goal of achieving a weekly target of 150 min of moderate-intensity, mixed-mode exercise. Assessments via self-administered survey and physical fitness and function tests occur at baseline and then at 6 and 9 months postbaseline. Data to inform feasibility and safety are recorded as case notes by the exercise professional during each session.Ethics and dissemination Ethics approval for the ECHO-R trial was granted by the Metro North Human Research Ethics Committee (HREC/2020/QRBW/67223) on 6 November 2020. Findings from the trial are planned to be disseminated via peer-reviewed publications and both national and international exercise and oncology conferences.Trial registration number ACTRN12621000042842