Personalised exercise rehabilitation in cancer survivorship: the percs triage and referral system study protocol.

BACKGROUND: To effectively embed exercise rehabilitation in cancer survivorship care, a co-ordinated system of acute and community exercise rehabilitation services, forming a stepped model of care, is recommended. Patients can be directed to the exercise rehabilitation service which best meets their needs through a system of assessment, triage and referral. Triage and referral systems are not yet widely applied in cancer survivorship practice and need to be evaluated in real-world contexts. The PERCS (Personalised Exercise Rehabilitation in Cancer Survivorship) study aims to evaluate the real-world application of an exercise rehabilitation triage and referral system in cancer survivors treated during the COVID-19 pandemic. Secondary aims are to evaluate change in physical and psychosocial outcomes, and to qualitatively evaluate the impact of the system and patient experiences, at three months after application of the triage and referral system. METHODS: This study will assess the implementation of an exercise rehabilitation triage and referral system within the context of a physiotherapy-led cancer rehabilitation clinic for cancer survivors who received cancer treatment during the COVID-19 pandemic. The PERCS triage and referral system supports decision making in exercise rehabilitation referral by recommending one of three pathways: independent exercise; fitness professional referral; or health professional referral. Up to 100 adult cancer survivors treated during the COVID-19 pandemic who have completed treatment and have no signs of active disease will be recruited. We will assess participants' physical and psychosocial wellbeing and evaluate whether medical clearance for exercise is needed. Participants will then be triaged to a referral pathway and an exercise recommendation will be collaboratively decided. Reassessment will be after 12 weeks. Primary outcomes are implementation-related, guided by the RE-AIM framework. Secondary outcomes include physical function, psychosocial wellbeing and exercise levels. Qualitative analysis of semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR) will provide insights on implementation and system impact. DISCUSSION: The PERCS study will investigate the real-world application of a cancer rehabilitation triage and referral system. This will provide proof of concept evidence for this triage approach and important insights on the implementation of a triage system in a specialist cancer centre. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, registration number: NCT05615285, date registered: 21st October 2022.

The acceptability of exercise prehabilitation before cancer surgery among patients, family members and health professionals: a mixed methods evaluation.

PURPOSE: Exercise prehabilitation aims to increase preoperative fitness, reduce post-operative complications, and improve health-related quality of life. For prehabilitation to work, access to an effective programme which is acceptable to stakeholders is vital. The aim was to explore acceptability of exercise prehabilitation before cancer surgery among key stakeholders specifically patients, family members and healthcare providers. METHODS: A mixed-methods approach (questionnaire and semi-structured interview) underpinned by the Theoretical Framework of Acceptability was utilised. Composite acceptability score, (summation of acceptability constructs and a single-item overall acceptability construct), and median of each construct was calculated. Correlation analysis between the single-item overall acceptability and each construct was completed. Qualitative data was analysed using deductive and inductive thematic analysis. RESULTS: 244 participants completed the questionnaire and n=31 completed interviews. Composite acceptability was comparable between groups (p=0.466). Four constructs positively correlated with overall acceptability: affective attitude (r=0.453), self-efficacy (r=0.399), ethicality (r=0.298) and intervention coherence (r=0.281). Qualitative data confirmed positive feelings, citing psychological benefits including a sense of control. Participants felt flexible prehabilitation program would be suitable for everyone, identifying barriers and facilitators to reduce burden. CONCLUSION: Exercise prehabilitation is highly acceptable to key stakeholders. Despite some burden, it is a worthwhile and effective intervention. Stakeholders understand its purpose, are confident in patients' ability to participate, and regard it is an important intervention contributing to patients' psychological and physical wellbeing. IMPLICATIONS: •Introduction should be comprehensively designed and clearly presented, providing appropriate information and opportunity for questions. •Programmes should be patient-centred, designed to overcome barriers and address patients' specific needs and goals. •Service must be appropriately resourced with a clear referral-pathway.

Measurement and optimization of perioperative risk among patients undergoing surgery for esophageal cancer.

Esophagectomy is an exemplar of complex oncological surgery and is associated with a relatively high risk of major morbidity and mortality. In the modern era, where specific complications are targeted in prevention and treatment pathways, and where the principles of enhanced recovery after surgery are espoused, optimum outcomes are targeted via a number of approaches. These include comprehensive clinical and physiological risk assessment, specialist perioperative care by a high-volume team, and multimodal inputs throughout the patient journey that aim to preserve or restore nutritional deficits, muscle mass and function.

ExPeCT: a randomised trial examining the impact of exercise on quality of life in men with metastatic prostate cancer.

PURPOSE: All patients living with cancer, including those with metastatic cancer, are encouraged to be physically active. This paper examines the secondary endpoints of an aerobic exercise intervention for men with metastatic prostate cancer. METHODS: ExPeCT (Exercise, Prostate Cancer and Circulating Tumour Cells), was a multi-centre randomised control trial with a 6-month aerobic exercise intervention arm or a standard care control arm. Exercise adherence data was collected via heart rate monitors. Quality of life (FACT-P) and physical activity (self-administered questionnaire) assessments were completed at baseline, at 3 months and at 6 months. RESULTS: A total of 61 patients were included (69.4 ± 7.3 yr, body mass index 29.2 ± 5.8 kg/m2). The median time since diagnosis was 34 months (IQR 7-54). A total of 35 (55%) of participants had > 1 region affected by metastatic disease. No adverse events were reported by participants. There was no effect of exercise on quality of life (Cohen's d = - 0.082). Overall adherence to the supervised sessions was 83% (329 out of 396 possible sessions attended by participants). Overall adherence to the non-supervised home exercise sessions was 72% (months 1-3) and 67% (months 3-6). Modelling results for overall physical activity scores showed no significant main effect for the group (p-value = 0.25) or for time (p-value = 0.24). CONCLUSION: In a group of patients with a high burden of metastatic prostate cancer, a 6-month aerobic exercise intervention did not lead to change in quality of life. Further exercise studies examining the role of exercise for people living with metastatic prostate cancer are needed. TRIAL REGISTRATION: The trial was registered at clinicaltrials.gov (NCT02453139) on May 25th 2015.

1-year quality of life and health-outcomes in patients hospitalised with COVID-19: a longitudinal cohort study.

BACKGROUND: Published studies suggest physical recovery from the COVID-19 is complex, with many individuals experiencing persistent symptoms. There is a paucity of data investigating the longer-term trajectory of physical recovery from COVID-19. METHODS: A prospective longitudinal design was utilised to investigate the impact COVID-19 has on physical functioning at 10-weeks (T1), 6-months (T2) and 1-year (T3) post-hospital discharge. Objective measures of recovery included 6-Minute Walk Test Distance (6MWTD), frailty (Clinical Frailty Scale), quantification of falls following hospital-discharge, return to work status and exercise levels. Subjective markers included symptoms (COVID-19-Specific Patient Concerns Assessment), fatigue (Chalder Fatigue Score) and health-related quality of life (HrQOL) [Short-Form-36 Health Survey Questionnaire (SF-36-II)]. Univariate analysis was performed using t-test, Wilcoxon rank-sum, and Chi-squared test, paired analysis using one-way analysis of variance and Krustal Wallis testing and correlation analysis with Spearman correlation tests. RESULTS: Sixty-one subjects participated. Assessments were conducted at a median of 55 days(T1), 242 days(T2), and 430 days(T3) following hospital-discharge. 6MWTD improved significantly overtime (F = 10.3, p < 0.001) from 365(209)m at T1 to 447(85)m at T3, however remained below population norms and with no associated improvement in perceived exertion. Approximately half (n = 27(51%)) had returned to pre-diagnosis exercise levels at T3. At least one concern/symptom was reported by 74%, 59% and 64% participants at T1, T2 and T3 respectively. Fatigue was the most frequently reported symptom at T1(40%) and T2(49%), while issues with memory/concentration was the most frequently reported at T3(49%). SF-36 scores did not change in any domain over the study period, and scores remained lower than population norms in the domains of physical functioning, energy/vitality, role limitations due to physical problems and general health. Return-to-work rates are low, with 55% of participants returning to work in some capacity, and 31% of participants don't feel back to full-health at 1-year following infection. CONCLUSION: Hospitalised COVID-19 survivors report persistent symptoms, particularly fatigue and breathlessness, low HrQOL scores, sub-optimal exercise levels and continued work absenteeism 1-year following infection, despite some objective recovery of physical functioning. Further research is warranted to explore rehabilitation goals and strategies to optimise patient outcomes during recovery from COVID-19. CLINICAL MESSAGE: Hospitalised COVID-19 survivors report significant ongoing rehabilitation concerns 1-year following infection, despite objective recovery of physical functioning. Our findings suggest those who returned to exercise within 1-year may have less fatigue and breathlessness. The impact of exercise, and other rehabilitative strategies on physical functioning outcomes following COVID-19 should be investigated in future research.

Identifying outcomes reported in exercise interventions in oesophagogastric cancer survivors: a systematic review.

BACKGROUND: Research investigating exercise interventions in oesophagogastric cancer survivors is sparse, and the outcomes are varied. The aim of this systematic review is to identify the domains and outcomes reported in exercise interventions in oesophagogastric cancer survivors to be included in a Delphi study, with a view to informing the development of a core outcome set (COS). METHODS: EMBASE, PubMed, CINHAL, Cochrane Library, SCOPUS, and PEDro were searched up to March 2020 using a predefined search strategy. The outcomes identified during data extraction were categorised using the core areas outlined in the OMERACT Filter 2.0. RESULTS: Fourteen domains and 63 outcomes were identified. The most frequently reported outcomes were in the domains of quality of life using the EORTC-QLQ-C30 questionnaire and the relevant disease-specific modules (100%), exercise capacity/fitness/physical function (100%), anthropometrics (83.33%), physical activity (66.67%), and biomarker analysis (50%). CONCLUSION: This systematic review quantifies and describes the domains and outcomes examined in exercise interventions in oesophagogastric cancer survivors. Some inconsistency exists within the domains and outcomes used, and little attention was given to nutritional or economic endpoints. In order to develop a COS, a Delphi consensus process with key stakeholders is needed to identify the relevant domains and outcomes for inclusion.

Preoperative exercise to improve fitness in patients undergoing complex surgery for cancer of the lung or oesophagus (PRE-HIIT): protocol for a randomized controlled trial.

BACKGROUND: Patients with cancer of the lung or oesophagus, undergoing curative treatment, usually require a thoracotomy and a complex oncological resection. These surgeries carry a risk of major morbidity and mortality, and risk assessment, preoperative optimisation, and enhanced recovery after surgery (ERAS) pathways are modern approaches to optimise outcomes. Pre-operative fitness is an established predictor of postoperative outcome, accordingly, targeting pre-operative fitness through exercise prehabilitation has logical appeal. Exercise prehabilitation is challenging to implement however due to the short opportunity for intervention between diagnosis and surgery. Therefore, individually prescribed, intensive exercise training protocols which convey clinically meaningful improvements in cardiopulmonary fitness over a short period need to be investigated. This project will examine the influence of exercise prehabilitation on physiological outcomes and postoperative recovery and, through evaluation of health economics, the impact of the programme on hospital costs. METHODS: The PRE-HIIT Randomised Controlled Trial (RCT) will compare a 2-week high intensity interval training (HIIT) programme to standard preoperative care in a cohort of thoracic and oesophageal patients who are > 2-weeks pre-surgery. A total of 78 participants will be recruited (39 per study arm). The primary outcome is cardiorespiratory fitness. Secondary outcomes include, measures of pulmonary and physical and quality of life. Outcomes will be measured at baseline (T0), and post-intervention (T1). Post-operative morbidity will also be captured. The impact of PRE-HIIT on well-being will be examined qualitatively with focus groups/interviews post-intervention (T1). Participant's experience of preparation for surgery on the PRE-HIIT trial will also be explored. The healthcare costs associated with the PRE-HITT programme, in particular acute hospital costs, will also be examined. DISCUSSION: The overall aim of this RCT is to examine the effect of tailored, individually prescribed high intensity interval training aerobic exercise on pre-operative fitness and postoperative recovery for patients undergoing complex surgical resections, and the impact on use of health services. TRIAL REGISTRATION: The study is registered with Clinical Trials.Gov (NCT03978325). Registered on 7th June 2019.

Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial.

BACKGROUND: Curative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver. METHODS: The ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed. DISCUSSION: This RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.

The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship.

OBJECTIVE: The Rehabilitation Strategies in Esophagogastric cancer (RESTORE) randomized controlled trial evaluated the efficacy of a 12-week multidisciplinary program to increase the cardiorespiratory fitness and health-related quality of life (HRQOL) of esophagogastric cancer survivors. BACKGROUND: Patients following treatment for esophagogastric cancer are at risk of physical deconditioning, nutritional compromise, and sarcopenia. Accordingly, compelling rationale exists to target these impairments in recovery. METHODS: Disease-free patients treated for esophagogastric cancer were randomized to either usual care or the 12-week RESTORE program (exercise training, dietary counseling, and multidisciplinary education). The primary outcome was cardiopulmonary exercise testing (VO2peak). Secondary outcomes included body composition (bioimpedance analysis), and HRQOL (EORTC-QLQ-C30). Outcomes were assessed at baseline (T0), postintervention (T1), and at 3-month follow-up (T2). RESULTS: Twenty-two participants were randomized to the control group [mean (standard deviation) age 64.14 (10.46) yr, body mass index 25.67 (4.83) kg/m, time postsurgery 33.68 (19.56) mo], and 21 to the intervention group [age 67.19(7.49) yr, body mass index 25.69(4.02) kg/m, time postsurgery 23.52(15.23) mo]. Mean adherence to prescribed exercise sessions were 94(12)% (supervised) and 78(27)% (unsupervised). Correcting for baseline VO2peak, the intervention arm had significantly higher VO2peak at both T1, 22.20 (4.35) versus 21.41 (4.49) mL ·â€Šmin ·â€Škg, P < 0.001, and T2, 21.75 (4.27) versus 20.74 (4.65) mL ·â€Šmin ·â€Škg, P = 0.001, compared with the control group. Correcting for baseline values, no changes in body composition or HRQOL were observed. CONCLUSIONS: The RESTORE program significantly improved cardiorespiratory fitness of disease-free patients after esophagogastric cancer surgery, without compromise to body composition. This randomized controlled trial provides proof of principle for rehabilitation programs in esophagogastric cancer. CLINICAL TRIAL REGISTRATION NUMBER: NCT03314311.

Sarcopenia during neoadjuvant therapy for oesophageal cancer: characterising the impact on muscle strength and physical performance.

PURPOSE: Preoperative chemo(radio)therapy for oesophageal cancer (OC) may have an attritional impact on body composition and functional status, impacting postoperative outcome. Physical decline with skeletal muscle loss has not been previously characterised in OC and may be amenable to physical rehabilitation. This study characterises skeletal muscle mass and physical performance from diagnosis to post-neoadjuvant therapy in patients undergoing preoperative chemo(radio)therapy for OC. METHODS: Measures of body composition (axial computerised tomography), muscle strength (handgrip), functional capacity (walking distance), anthropometry (weight, height and waist circumference), physical activity, quality-of-life and nutritional status were captured prospectively. Sarcopenia status was defined as pre-sarcopenic (low muscle mass only), sarcopenic (low muscle mass and low muscle strength or function) or severely sarcopenic (low muscle mass and low muscle strength and low muscle function). RESULTS: Twenty-eight participants were studied at both time points (mean age 62.86 ± 8.18 years, n = 23 male). Lean body mass reduced by 4.9 (95% confidence interval 3.2 to 6.7) kg and mean grip strength reduced by 4.3 (2.5 to 6.1) kg from pre- to post-neoadjuvant therapy. Quality-of-life scores capturing gastrointestinal symptoms improved. Measures of anthropometry, walking distance, physical activity and nutritional status did not change. There was an increase in sarcopenic status from diagnosis (pre-sarcopenic n = 2) to post-treatment (pre-sarcopenic n = 5, severely sarcopenic n = 1). CONCLUSIONS: Despite maintenance of body weight, functional capacity and activity habits, participants experience declines in muscle mass and strength. Interventions involving exercise and/or nutritional support to build muscle mass and strength during preoperative therapy, even in patients who are functioning normally, are warranted.

Sarcopenia: Prevalence, and Impact on Operative and Oncologic Outcomes in the Multimodal Management of Locally Advanced Esophageal Cancer.

OBJECTIVE: The aim of this article was to study the prevalence and significance of sarcopenia in the multimodal management of locally advanced esophageal cancer (LAEC), and to assess its independent impact on operative and oncologic outcomes. SUMMARY OF BACKGROUND DATA: Sarcopenia in cancer may confer negative outcomes, but its prevalence and impact on modern multimodal regimens for LAEC have not been systematically studied. METHODS: Two hundred fifty-two consecutive patients were studied. Lean body mass (LBM), skeletal muscle index (SMI), and fat mass (FM) were determined pre-treatment, preoperatively, and 1 year postoperatively. Sarcopenia was defined by computed tomography (CT) at L3 as SMI < 52.4 cm/m for males and SMI < 38.5 cm/m for females. All complications were recorded prospectively, including comprehensive complications index (CCI), Clavien-Dindo complication (CDC), and pulmonary complications (PPCs). Multivariable linear, logistic, and Cox regression analysis was performed. RESULTS: In-hospital mortality was 1%, and CCI was 21 ±â€Š19. Sarcopenia increased (P = 0.02) from 16% at diagnosis to 31% post-neoadjuvant therapy, with loss of LBM (-3.0 ±â€Š5.4 kg, P < 0.0001), but not FM (-0.3 ±â€Š2.7 kg, P= 0.31) during treatment. On multivariable analysis, preoperative sarcopenia was associated with CCI (P = 0.043), and CDC ≥IIIb (P = 0.003). PPCs occurred in 36% nonsarcopenic versus 55% sarcopenic patients (P = 0.01). Sarcopenia did not impact disease-specific (P = 0.14) or overall survival (P = 0.11) after resection. At 1 year, 35% had sarcopenia, significantly associated with pre-treatment BMI (P = 0.013) but not complications (P = 0.20). CONCLUSIONS: Sarcopenia increases through multimodal therapy, is associated with an increased risk of major postoperative complications, and is prevalent in survivorship. These data highlight a potentially modifiable marker of risk that should be assessed and targeted in modern multimodal care pathways.

Weight Loss, Satiety, and the Postprandial Gut Hormone Response After Esophagectomy: A Prospective Study.

OBJECTIVE: To prospectively characterize changes in body weight, satiety, and postprandial gut hormone profiles following esophagectomy. BACKGROUND: With improved oncologic outcomes in esophageal cancer, there is an increasing focus on functional status and health-related quality of life in survivorship. Early satiety and weight loss are common after esophagectomy, but the pathophysiology of these phenomena remains poorly understood. METHODS: In this prospective study, consecutive patients undergoing esophagectomy with gastric conduit reconstruction were studied preoperatively and at 10 days, 6 weeks, and 3 months postoperatively. Glucagon-like peptide 1 (GLP-1) immunoreactivity of plasma collected immediately before and at 15, 30, 60, 90, 120, 150, and 180 minutes after a standardized 400-kcal mixed meal was determined. Gastrointestinal symptom scores were computed using European Organization for Research and Treatment of Cancer questionnaires. RESULTS: Body weight loss at 6 weeks and 3 months postoperatively among 13 patients undergoing esophagectomy was 11.1 ±â€Š2.3% (P < 0.001) and 16.3 ±â€Š2.2% (P < 0.0001), respectively. Early satiety (P = 0.043), gastrointestinal pain and discomfort (P = 0.01), altered taste (P= 0.006), and diarrhea (P= 0.038) scores increased at 3 months postoperatively. Area under the curve for the satiety gut hormone GLP-1 was significantly increased from 10 days postoperatively (2.4 ±â€Š0.2-fold increase, P < 0.01), and GLP-1 peak increased 3.8 ±â€Š0.6-, 4.7 ±â€Š0.8-, and 4.4 ±â€Š0.5-fold at 10 days, 6 weeks, and 3 months postoperatively (all P < 0.0001). Three months postoperatively, GLP-1 area under the curve was associated with early satiety (P = 0.0002, R = 0.74), eating symptoms (P = 0.007, R = 0.54), and trouble enjoying meals (P = 0.0004, R = 0.73). CONCLUSIONS: After esophagectomy, patients demonstrate an exaggerated postprandial satiety gut hormone response, which may mediate postoperative changes in satiety, body weight, and gastrointestinal quality of life.

Effects of a multimodal rehabilitation programme on inflammation and oxidative stress in oesophageal cancer survivors: the ReStOre feasibility study.

PURPOSE: Physical, nutritional and quality-of-life compromises are known sequelae of oesophageal cancer (OC) treatment. Inflammation and oxidative stress may be relevant to adverse consequences. Multimodal rehabilitation involving exercise and diet prescription may attenuate some of the negative consequences and optimise survivorship, and this was assessed in this feasibility study in OC patients at least 1 year post-oesophagectomy. METHODS: The 12-week programme included supervised and home-based exercise, dietetic counselling to ensure energy balance and multidisciplinary education. Baseline and post-intervention assessments examined aerobic fitness, physical activity and body composition. Serum interleukin (IL)-1ß, tumour necrosis factor (TNF)-α, IL-6 and IL-8 were measured via multiplex arrays. Lactate secretion, lipid peroxidation (4-HNE) and oxidative stress (8-iso-PGF2α) were measured by enzyme-linked immunosorbent assay (ELISA). RESULTS: Twelve patients (mean (SD) age 64(1.29) years) participated. IL-8 reduced significantly from pre- to post-intervention (percentage change -11.25 % (95 % CI -20.98 to -1.51 %), p = 0.03), and there was a non-significant trend towards lower expression patterns of other inflammatory mediators. At baseline, inflammatory status correlated inversely with sedentary behaviour (IL-6 rho = -0.74, IL-8 rho = -0.59, TNF-α rho = -0.69; p < 0.05). While energy metabolism did not change, post-intervention lactate concentration correlated strongly and inversely with aerobic fitness (rho = -0.68, p = 0.02). Body composition was maintained throughout the intervention. CONCLUSIONS: Results suggest that multimodal rehabilitation following OC treatment reduced inflammatory status without compromising body composition. Findings will be further examined in a larger randomised controlled trial.

Physical activity and life-limiting conditions.

BACKGROUND: Physical activity can assist people with life-limiting conditions to maintain their wellbeing and quality of life. AIMS: To explore the views of clinical nurse specialists (CNS) working in community palliative care towards the role of physical activity for people with life-limiting conditions, and to explore the physical activity needs of patients with life-limiting conditions identified by CNSs. METHODS: A purposive sample of CNSs working in community palliative care received an anonymous online survey via email. FINDINGS: The response rate was 66% (n=20). Most respondents were practicing for over 20 years (60%, n=12). All respondents (100%, n=20) reported they would like further information on the role of exercise for palliative populations. The main perceived benefit of physical activity was to improve quality of life (95%, n=18). A lack of physical activity guidelines for people living with life-limiting conditions was the most commonly reported barrier to engaging in discussions around physical activity (74%, n=14). CONCLUSION: Further education opportunities on the role of physical activity for patients living with life-limiting conditions are needed.

Feasibility metrics of exercise interventions during chemotherapy: A systematic review.

BACKGROUND: Exercise has been shown to play an important role in managing chemotherapy-related side effects, preserving skeletal muscle mass, and attenuating decline in cardiorespiratory fitness associated with chemotherapy treatment, however, the feasibility of how these exercise programs are being delivered has yet to be synthesized. The objective of this review was to measure the rates of recruitment, adherence, and retention to exercise programs delivered for cancer patients during chemotherapy. METHODS: Relevant studies were identified through a search of MEDLINE, Cochrane, EMBASE and CINAHL databases from January 2002 to July 2022 using keywords relating to exercise interventions during chemotherapy. Title and abstract screening, full text review, data extraction, and quality assessment were all performed independently by two reviewers. RESULTS: A total of 36 studies were included in the review. The mean recruitment rate for the included studies was 62.39% (SD = 19.40; range 25.7-95%). Travel was the most common reason for declining recruitment in these trials. Adherence rates ranged from 17-109%, however the definition of adherence varied greatly between studies. Mean retention rates for the exercise groups was 84.1% (SD = 12.7; range 50-100%), with chemotherapy side effects being the most common reason why participants dropped out of these trials. CONCLUSION: Multiple challenges exist for cancer patients during chemotherapy and careful consideration needs to be given when designing an exercise program for this population. Future research should include public and patient involvement to ensure exercise programs are pragmatic and patient centred.

A prospective investigation of predictive and modifiable risk factors for breast cancer in unaffected BRCA1 and BRCA2 gene carriers.

BACKGROUND: Breast cancer is the most common female cancer worldwide. The lifetime risk of a woman being diagnosed with breast cancer is approximately 12.5%. For women who carry the deleterious mutation in either of the BRCA genes, BRCA1 or BRCA2, the risk of developing breast or ovarian cancer is significantly increased. In recent years there has been increased penetrance of BRCA1 and BRCA2 associated breast cancer, prompting investigation into the role of modifiable risk factors in this group. Previous investigations into this topic have relied on participants recalling lifetime weight changes and subjective methods of recording physical activity. The influence of obesity-related biomarkers, which may explain the link between obesity, physical activity and breast cancer risk, has not been investigated prospectively in this group. This paper describes the design of a prospective cohort study investigating the role of predictive and modifiable risk factors for breast cancer in unaffected BRCA1 and BRCA2 gene mutation carriers. METHODS/DESIGN: Participants will be recruited from breast cancer family risk clinics and genetics clinics. Lifestyle risk factors that will be investigated will include body composition, metabolic syndrome and its components, physical activity and dietary intake. PBMC telomere length will be measured as a potential predictor of breast cancer occurrence. Measurements will be completed on entry to the study and repeated at two years and five years. Participants will also be followed annually by questionnaire to track changes in risk factor status and to record cancer occurrence. Data will be analysed using multiple regression models. The study has an accrual target of 352 participants. DISCUSSION: The results from this study will provide valuable information regarding the role of modifiable lifestyle risk factors for breast cancer in women with a deleterious mutation in the BRCA gene. Additionally, the study will attempt to identify potential blood biomarkers which may be predictive of breast cancer occurrence.

The presentation of metabolic dysfunction and the relationship with energy output in breast cancer survivors: a cross-sectional study.

BACKGROUND: Breast cancer prognosis can be adversely influenced by obesity, physical inactivity and metabolic dysfunction. Interventions aimed at improving surrogate markers of breast cancer risk such as insulin resistance may result in improved breast cancer outcomes. The design of such interventions may be improved through increased understanding of metabolic presentation in this cohort. This cross-sectional study aimed to characterise the metabolic profile of breast cancer survivors relative to abdominal obesity and insulin resistance. A secondary aim was to compare measures of energy output across these groups. METHODS: Sixty-nine women (mean (SD) age 53.43 (9.39) years) who had completed adjuvant chemotherapy and radiotherapy for breast cancer were recruited. All measures were completed during one assessment conducted 3.1 (1.0) years post diagnosis. Body composition was measured by bioimpedance analysis and waist circumference (WC). Fasting (12 hour) blood samples were drawn to measure lipid profile, glucose, insulin, glycosylated haemoglobin A1c (HBA1c) and C-reactive protein (CRP). Insulin resistance was estimated by the homeostatic model assessment index (HOMA-IR)). Energy output was evaluated by resting metabolic rate (RMR) measured by indirect calorimetry and physical activity measured by accelerometry. Characteristics were compared across four groups (1. WC <80 cm, not insulin resistant; 2. WC 80-87.9 cm, not insulin resistant; 3. WC >88 cm, not insulin resistant; 4. WC >80 cm, insulin resistant) using ANOVA (p < 0.05). RESULTS: Group 4 was characterised by significant disturbances in measures of glucose metabolism (glucose, insulin, HOMA-IR and HBA1c) and raised CRP compared to other groups. Group 4 also displayed evidence of dyslipidemia and higher body composition values compared to Groups 1 and 2. Both absolute and adjusted RMR were significantly higher in the Group 4 versus all other groups. Physical activity levels were similar for all groups. CONCLUSIONS: The results from this study suggest that participants who were both centrally obese and insulin resistant showed evidence of dyslipidemia, low-grade inflammation and glucose dysregulation. Metabolic profiles of participants who were centrally obese only were not significantly different from lean participants. Consideration of baseline metabolic presentation may be useful when considering the therapeutic targets for future interventions in this cohort.

A hospital to community exercise referral pathway: results of a pilot project.

BACKGROUND: People living with chronic disease should ideally engage with community-based exercise services following hospital-based rehabilitation. However, transition from hospital to community exercise settings is extremely challenging and strategies to support this transition are underdeveloped. AIMS: The aims of this study were to develop and explore the feasibility of a pilot exercise referral pathway between an acute hospital and community gyms for patients with chronic health conditions and to evaluate patient satisfaction with the exercise referral pathway. METHODS: A stakeholder-informed exercise referral pathway was developed and offered to patients following completion of a hospital-based exercise programme for a chronic health condition. The pathway was evaluated using a mixed-methods approach. Quantitative data examining participant engagement was used to examine feasibility. Quantitative survey data and qualitative data from semi-structured interviews examined satisfaction with the pathway. RESULTS: Forty-nine people living with chronic conditions (mean age 72 ± 7.8 years) participated (recruitment rate 59%). The average number of community gym visits over 4 months was 17.4 (range 0-51). Twenty-nine (78%) participants reported that they planned to continue their gym membership when the programme ended. Themed responses from participant interviews (n = 12) highlighted the benefits of a supported transition from hospital to gym membership and the need for more structured exercise support in community gyms. CONCLUSION: A structured exercise referral pathway to support exercise transition between hospital and community settings in populations with chronic health conditions appears feasible. Participants reported high levels of satisfaction with the referral pathway.

Moving Forward With Telehealth in Cancer Rehabilitation: Patient Perspectives From a Mixed Methods Study.

BACKGROUND: The COVID-19 pandemic accelerated the use of telehealth in cancer care and highlighted the potential of telehealth as a means of delivering the much-needed rehabilitation services for patients living with the side effects of cancer and its treatments. OBJECTIVE: This mixed methods study aims to explore patients' experiences of telehealth and their preferences regarding the use of telehealth for cancer rehabilitation to inform service development. METHODS: The study was completed in 2 phases from October 2020 to November 2021. In phase 1, an anonymous survey (web- and paper-based) exploring the need, benefits, barriers, facilitators, and preferences for telehealth cancer rehabilitation was distributed to survivors of cancer in Ireland. In phase 2, survivors of cancer were invited to participate in semistructured interviews exploring their experiences of telehealth and its role in cancer rehabilitation. Interviews were conducted via telephone or video call following an interview guide informed by the results of the survey and transcribed verbatim, and reflexive thematic analysis was performed using a qualitative descriptive approach. RESULTS: A total of 48 valid responses were received. The respondents were at a median of 26 (range 3-256) months after diagnosis, and 23 (48%) of the 48 participants had completed treatment. Of the 48 respondents, 31 (65%) reported using telehealth since the start of the pandemic, 15 (31%) reported having experience with web-based cancer rehabilitation, and 43 (90%) reported a willingness for web-based cancer rehabilitation. A total of 26 (54%) of the 48 respondents reported that their views on telehealth had changed positively since the start of the pandemic. Semistructured interviews were held with 18 survivors of cancer. The mean age of the participants was 58.9 (SD 8.24) years, 56% (10/18) of the participants were female, and 44% (8/18) of the participants were male. Reflexive thematic analysis identified 5 key themes: telehealth improves accessibility to cancer rehabilitation for some but is a barrier for others, lived experiences of the benefits of telehealth in survivorship, the value of in-person health care, telehealth in cancer care and COVID-19 (from novelty to normality), and the future of telehealth in cancer rehabilitation. CONCLUSIONS: Telehealth is broadly welcomed as a mode of cancer rehabilitation for patients living with and beyond cancer in Ireland. However, issues regarding accessibility and the importance of in-person care must be acknowledged. Factors of convenience, time savings, and cost savings indicate that telehealth interventions are a desirable patient-centered method of delivering care when performed in suitable clinical contexts and with appropriate populations.

Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial.

Background: Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ' Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial', a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors. Methods: This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James's Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit. Results: The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date. Conclusion: This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial. Registration: ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.