Study protocol for a single-site feasibility study evaluating the adoption and fidelity of Prep-4-RT: prehabilitation for head and neck cancer patients undergoing radiotherapy
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SUBMITTER: Ray H
PROVIDER: S-EPMC11295311 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:PurposeRadiotherapy imposes a significant physiological and psychological burden on gynaecological cancer patients. Prehabilitation is being increasingly used to prepare individuals for cancer treatment and improve their well-being and resilience. Whilst prehabilitation has demonstrated benefit for individuals undergoing cancer surgery, the structure, role and implementation of prehabilitation prior to radiotherapy are poorly defined and relatively unexplored. This scoping review aims to provide a comprehensive overview of the current literature regarding prehabilitation interventions for individuals with gynaecological cancer undergoing radiotherapy.MethodsThis review was conducted following the gold-standard Joanna Briggs Institute guidelines for scoping reviews. Literature searches were completed in October 2024 across: the Allied and Complementary Medicine Database; British Nursing Index; Cumulative Index to Nursing and Allied Health Literature; Cochrane library (Controlled trials and systematic reviews); Embase; Medical Literature Analysis and Retrieval System Online; and the Psychological Information Database. Grey literature searches were conducted via Google Scholar, Overton.io, and Trip Pro Medical Database.ResultsNinety records met the inclusion criteria, pertaining to 56 studies. Cervical cancer was the most represented gynaecological cancer type across studies. A small number of multimodal prehabilitation studies were identified (n = 4). Studies evaluating unimodal interventions were more common, with nutritional interventions (n = 24) being the most frequent, followed by psychological (n = 22) and physical exercise (n = 6) interventions. There was considerable variation across studies in respect to intervention initiation, duration, delivery and outcome measures.ConclusionsThe physiological and psychological impacts of cancer diagnosis and treatment are closely entwined. Further development of multimodal prehabilitation to cohesively address these is an important area for future research. Studies evaluating exercise interventions are relatively unexplored in this patient population and the potential barriers to engagement must be considered. Future research should focus on complete and transparent reporting of interventions, with input from those with lived experience, and adopting a standardised set of outcome measures reported across all trials.
| S-EPMC11906083 | biostudies-literature
Project description:ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) to evaluate a prehabilitation programme for frail patients undergoing total hip replacement (THR) or total knee replacement (TKR).DesignRandomised feasibility study with embedded qualitative work.SettingThree National Health Service hospitals.ParticipantsAdults aged ≥65 years, frail and scheduled for primary THR or TKR.InterventionAppointment with a physiotherapist to individualise a home-based exercise programme. Participants were encouraged to do the home exercises daily for 12 weeks pre-operative and were provided with a daily protein supplement. Participants were supported by six telephone calls over the 12-week intervention period.Outcome measuresEligibility and recruitment rates, intervention adherence, data completion rates of patient-reported outcome measures, retention rates and acceptability of the trial and intervention. Qualitative interviews were conducted with participants and non-participants and analysed using thematic analysis.ResultsBetween December 2022 and August 2023, 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants (73%) completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% (55/64 overall) at 12 weeks. The 12-week follow-up questionnaire was returned by 46 of the 55 participants (84%) who were sent a questionnaire. Interviews with 19 patients found that the trial processes and intervention were generally acceptable, but areas of potential improvements were identified.ConclusionsThis study demonstrated that a larger study is possible and has identified improvements to optimise the design of an RCT.Trial registration numberISRCTN11121506.
| S-EPMC11409239 | biostudies-literature
Project description:BackgroundApproximately, 8% of community-based adults aged ≥ 50 years in England are frail. Frailty has been found to be associated with poorer outcomes after joint replacement. Targeting frailty preoperatively via exercise and protein supplementation has the potential to improve outcomes for people undergoing joint replacement. Prior to proceeding with a randomised controlled trial (RCT), a feasibility study is necessary to address key uncertainties and explore how to optimise trial design and delivery.MethodsThe Joint PRehabilitation with Exercise and Protein (Joint PREP) study is a feasibility study for a multicentre, two-arm, parallel group, pragmatic, RCT to evaluate the clinical and cost-effectiveness of prehabilitation for frail patients undergoing total hip or knee replacement. Sixty people who are ≥ 65 years of age, frail according to the self-reported Groningen Frailty Indicator, and scheduled to undergo total hip or knee replacement at 2-3 hospitals in England and Wales will be recruited and randomly allocated on a 1:1 ratio to the intervention or usual care group. The usual care group will receive the standard care at their hospital. The intervention group will be given a daily protein supplement and will be asked to follow a home-based, tailored daily exercise programme for 12 weeks before their operation, in addition to usual care. Participants will be supported through six follow-up calls from a physiotherapist during the 12-week intervention period. Study questionnaires will be administered at baseline and 12 weeks after randomisation. Embedded qualitative research with patients will explore their experiences of participating, reasons for nonparticipation, and/or reasons for withdrawal or treatment discontinuation. Primary feasibility outcomes will be eligibility and recruitment rates, adherence to the intervention, and acceptability of the trial and the intervention.DiscussionThis study will generate important data regarding the feasibility of a RCT to evaluate a prehabilitation intervention for frail patients undergoing total hip and knee replacement. A future phase-3 RCT will determine if preoperative exercise and protein supplementation improve the recovery of frail patients after primary joint replacement.Trial registrationISRCTN11121506, registered 29 September 2022.
| S-EPMC10405490 | biostudies-literature
Project description:BackgroundEpidermal growth factor receptor (EGFR) activation is associated with increased production of interleukin 6 (IL6), which is intensified by radiotherapy (RT) induced inflammatory response. Elevated IL6 levels intensifies RT-induced anemia by upregulating hepcidin causing functional iron deficiency. Cetuximab, an EGFR inhibitor, has been associated with lower rates of anemia for locally advanced head and neck squamous cell carcinoma (HNSCC). We hypothesized that concomitant cetuximab could prevent RT-induced anemia.MethodsWe queried our institutional head and neck cancers database for non-metastatic HNSCC cases that received RT with concomitant cetuximab or RT-only between 2006 and 2018. Cetuximab was administered for some high-risk cases medically unfit for platinum agents per multidisciplinary team evaluation. We only included patients who had at least one complete blood count in the 4 months preceding and after RT. We compared the prevalence of anemia (defined as hemoglobin (Hb) below 12 g/dL in females and 13 g/dL in males) and mean Hb levels at baseline and after RT. Improvement of anemia/Hb (resolution of baseline anemia and/or an increase of baseline Hb ≥1 g/dL after RT), and overall survival (OS) in relation to anemia/Hb dynamics were also compared.ResultsA total of 171 patients were identified equally distributed between cetuximab-plus-RT and RT-only groups. The cetuximab-plus-RT group had more locally-advanced stage, oropharyngeal and high grade tumors (p < 0.001 for all). Baseline anemia/Hb were similar, however anemia after RT conclusion was higher in the cetuximab-plus-RT vs RT-only (63.5% vs. 44.2%; p = 0.017), with a mean Hb of 11.98 g/dL vs. 12.9 g/dL; p = 0.003, for both respectively. This contributed to significantly worse anemia/Hb improvement for cetuximab-plus-RT (18.8% vs. 37.2%; p = 0.007). This effect was maintained after adjusting for other factors in multivariate analysis. The prevalence of iron, vitamin-B12 and folate deficiencies; and chronic kidney disease, was non-different. Baseline anemia was associated with worse OS (p = 0.0052) for the whole study cohort. Nevertheless, improvement of anemia/Hb was only marginally associated with better OS (p = 0.068).ConclusionsIn contrast to previous studies, cetuximab was not associated with lower rates of anemia after RT for nonmetastatic HNSCC patients compared to RT-alone. Dedicated prospective studies are needed to elucidate the effect of cetuximab on RT-induced anemia.
| S-EPMC9175328 | biostudies-literature
Project description:IntroductionBioelectrical impedance analysis (BIA) serves as a method to estimate body composition. Parameters such as phase angle (PA), standardized phase angle (SPA), body mass cell (BCM), BCM index (BCMI), and fat-free mass (FFM) might significantly impact the prognosis of head and neck cancer (HNC) patients. The present study aimed to investigate whether bioelectrical parameters can be used to predict survival in the HNC population and establish the optimal cutoff points for predictive accuracy.MethodsA multicenter observational study was performed across 12 tertiary hospitals in Andalusia (a region from the south of Spain). A total of 494 patients diagnosed with HNC between 2020 and 2022 at different stages were included in this study, with a minimum follow-up period of 12 months. The BIA assessment was carried out during the first 2 weeks of radical radiotherapy treatment with chemotherapy or other systemic treatments. A multivariate logistic regression analysis of overall survival, complications, hospital admission, and palliative care and its relationship with BIA nutritional assessment was performed.ResultsSignificant prognostic factors identified in the multivariable analysis encompassed phase angle (PA), standardized phase angle (SPA), body cell mass (BCM), and BCM index (BCMI). Lower PA and BCM values were significantly associated with adverse clinical outcomes. A BCM threshold above 17 kg/m2 was the most significant predictor for predicting survival within the overall HNC population. The PA values of <5.1° in male and <4.8° in female patients showed the best predictive potential for mortality. Increased PA (as a continuous variable) demonstrated a significantly reduced risk for mortality (OR, 0.64; 95% CI, 0.43-0.94; p < 0.05) and a decreased likelihood of hospital admission (OR, 0.75; 95% CI, 0.52-1.07; p < 0.05). Higher BCM correlated with a lower risk of mortality (OR, 0.88; 95% CI, 0.80-0.96; p < 0.01) and a diminished probability of hospital admission (OR, 0.91; 95% CI, 0.83-0.99; p < 0.05).ConclusionBIA is a crucial tool in the nutritional assessment of HNC patients. BCM and PA are the main bioelectrical parameters used to predict clinical outcomes in this population. Future studies are needed to validate BIA variables in a large cohort to ensure whether early intensification of nutritional treatment would improve survival.
| S-EPMC10921554 | biostudies-literature
Project description:BackgroundHead and neck cancer (HNC) patients suffer from a series of complications due to changes in body image caused by radiotherapy, resulting in patients' unwillingness to participate in society and a strong sense of social alienation. Social alienation not only affects the physical and mental health and quality of life of individuals but also increases the pressure on the families and society of HNC patients, which may lead to a series of social problems. Therefore, this study explores social alienation in patients with HNC treated at our center and analyses its influencing factors, to provide a basis for the development of relevant nursing interventions.MethodsIn this study, 236 patients with HNC who were treated in a tertiary hospital in northeast China from September 2023 to June 2024 were investigated by a convenient sampling method. The survey was conducted using general demographic information, the General Alienation Scale (GAS), the Fear of Progress Questionnaire-Short Form (FoP-Q-SF), the Self-Perceived Burden Scale (SPBS), and the Social Support Scale (SRSS). Data were collected by paper scale. The data were processed by SPSS26.0 software, and the influencing factors of patients' social alienation were analyzed by single-factor analysis and multiple linear regression. The writing process of this article follows the STROBE principle.ResultsThe total GAS score of patients with radiotherapy for HNC was 33.45 ± 5.77, which was in the upper-middle level. Fear of disease progression and self-perceived burden were significantly positively correlated with social alienation (r = 0.414, p < 0.01; r = 0.422, p < 0.01), and social support was significantly negatively correlated with social alienation (r=-0.342, p < 0.01). Multiple linear regression analysis showed that retirement (β = 0.156, p < 0.01), education level (β=-0.123, p = 0.029), number of radiotherapy treatments (β = 0.120, p = 0.033), fear of disease progression (β = 0.228, p < 0.01), self-perceived burden (β = 0.228, p < 0.01), and social support (β=- 0.222, p < 0.01) were the main influences on social alienation in radiotherapy patients with HNC (t value is -3.894 to 3.252, p < 0.05), explaining 31.9% of the total variance.ConclusionThe social alienation in patients undergoing radiotherapy for HNC is at a moderately high level. Clinical medical staff should pay attention to the social alienation of HNC patients, pay more attention to patients who are in the retirement stage, with low education level and undergoing radiotherapy. By alleviating patients' fear of disease progression, reducing self-perceived burden, and enhancing social support, healthcare providers can effectively reduce their level of social alienation.Clinical trial numberNot applicable.
| S-EPMC11905440 | biostudies-literature
Project description:BackgroundThe concept of "prehabilitation," or optimising individual physical and mental wellbeing prior to surgery is well established in cancer and orthopaedic populations. However, amongst the cardiac surgery population, the concept is relatively new. Of the few studies available, all focus on the elective surgical population. This pilot feasibility trial is novel as it will focus on the impact of multimodal prehabilitation on the acute inpatient cardiac surgical population.MethodsThis single centre, prospective, single arm pilot feasibility trial will recruit 20 inpatients awaiting cardiac surgery. Measurements will be collected at the start of the trial (baseline), 7 days after intervention, and 14 days after the intervention or before the day of surgery. The primary outcome measure will be feasibility and practicality of the programme in an acute inpatient population. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include incidence of study-related adverse events, improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, anxiety scores and spirometry. At the end of the trial, we will be seeking the feedback of the participants on key components of the programme to help us inform future work. We hypothesise that light to moderate structured exercise training is low risk and feasible in patients awaiting inpatient cardiac surgery. The study was approved by Health Research Authority and Heath and Care Research Wales (Yorkshire & the Humber- Bradford Leeds Research Ethics Committee: REC reference 23/YH/0255) on the 8th November 2023.DiscussionMultimodal prehabilitation could improve individual physical and mental wellbeing whilst awaiting inpatient cardiac surgery. Prehabilitation can provide individuals with a sense of ownership and control over their condition, improve their motivation and independence, and enhance their mental and physical recovery after surgery. Traditionally, patients waiting for cardiac surgery are discouraged from physical activity/ structured exercise training and receive limited information regarding their health. Appropriate physical and psychological support could improve their confidence to mobilise sooner after surgery. This may then facilitate earlier discharge leading to improved hospital bed utilisation and patient flow.Trial registrationClinicalTrials.gov NCT06275100.
| S-EPMC11892877 | biostudies-literature
Project description:Patients with curable non-surgical lung cancer are often current smokers, have co-existing medical comorbidities and are treated with curative radiotherapy. To maximise the benefits of modern radiotherapy, there is an urgent need to optimise the patient's health to improve survival and quality of life.Methods and analysisThe Yorkshire Cancer Research-funded Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) (L426) is a single-centre prospective feasibility study to assess embedding behavioural changes into the radical radiotherapy pathway of patients with lung cancer. Feasibility will be assessed by measuring acceptability, demand and implementation. The duration of the study is 24 months. PREHABS has two workstreams: the intervention study and the theory of change (ToC) study.Intervention study: PREHABS will commence at the R-IDEAL phase 2 trial (exploratory) based on existing evidence and includes support for smoking cessation, increasing activity and dietary well-being. Patients undergoing radical radiotherapy for lung cancer will be recruited from the oncology department at Leeds Teaching Hospitals NHS Trust (LTHT). ToC study: to maximise the acceptability and adherence to the PREHABS, we will use a ToC approach to qualitatively explore the key barriers and enablers of implementing a tailored programme of 'prehabilitation'. The PREHABS ToC study participants will be recruited from patients with lung cancer undergoing radical radiotherapy and staff from the LTHT oncology department.AnalysisThe primary endpoint analysis will report the number of participants and adherence to the study interventions. Secondary endpoints include continued engagement with study interventions post-treatment. The analysis will focus on descriptive statistics. Thematic analysis of the qualitative data from the ToC study will identify consensus on intervention optimisation and delivery.Ethics and disseminationOn 12 May 2021, the Cambridge East Ethics Committee granted ethical approval (21/EE/0048). The study is registered in the National Institute for Health and Care Research (NIHR) portfolio. The results will be disseminated through publication in peer-reviewed scientific journals and presented at conferences.Trial registration numberNIHR portfolio 48420.
| S-EPMC10824008 | biostudies-literature
Project description:Background and purposeAnatomical changes during radiotherapy pose a challenge to robustness of plans. Principal component analysis (PCA) is commonly used to model such changes. We propose a toolbox to evaluate how closely a given PCA model can represent actual deformations seen in the patient and highlight regions where the model struggles to capture these changes.Materials and methodsWe propose to calculate a residual error map from the difference between an actual displacement vector field (DVF) and the closest DVF that the PCA model can produce. This was done by taking the inner product of the DVF with the PCA components from the model. As a global measure of error, the 90th percentile of the residual errors (Mres90 ) across the whole scan was used. As proof of principle, we demonstrated this approach on both patient-specific cases and a population-based PCA in head and neck (H&N) cancer patients. These models were created using deformation data from deformable registrations between the planning computed tomography and cone-beam computed tomography (CBCTs), and were evaluated against DVFs from registrations of CBCTs not used to create the model.ResultsFor our example cases, the oropharyngeal and the nasal cavity regions showed the largest local residual error, indicating the PCA models struggle to predict deformations seen in these regions. Mres90 ranged from 0.4 mm to 6.3 mm across the different models.ConclusionsA method to quantitatively evaluate how well PCA models represent observed anatomical changes was proposed. We demonstrated our approach on H&N PCA models, but it can be applied to other sites.
| S-EPMC9038571 | biostudies-literature
Project description:IntroductionPatients receiving radiotherapy are at risk of developing radiotherapy-related insufficiency fractures, which are associated with increased morbidity and pose a significant burden to patients' quality of life and to the health system. Therefore, effective preventive techniques are urgently required. The RadBone randomised controlled trial (RCT) aims to determine the feasibility and acceptability of a musculoskeletal health package (MHP) intervention in women undergoing pelvic radiotherapy for gynaecological malignancies and to preliminary explore clinical effectiveness of the intervention.Methods and analysisThe RadBone RCT will evaluate the addition to standard care of an MHP consisting of a physical assessment of the musculoskeletal health, a 3-month prehabilitation personalised exercise package, as well as an evaluation of the fracture risk and if required the prescription of appropriate bone treatment including calcium, vitamin D and-for high-risk individuals-bisphosphonates. Forty participants will be randomised in each group (MHP or observation) and will be followed for 18 months. The primary outcome of this RCT will be feasibility, including the eligibility, screening and recruitment rate, intervention fidelity and attrition rates; acceptability and health economics. Clinical effectiveness and bone turnover markers will be evaluated as secondary outcomes.Ethics and disseminationThis study has been approved by the Greater Manchester East Research Ethics Committee (Reference: 20/NW/0410, November 2020). The results will be published in peer-reviewed journals, will be presented in national and international conferences and will be communicated to relevant stakeholders. Moreover, a plain English report will be shared with the study participants, patients' organisations and media.Trial registration numberNCT04555317.
| S-EPMC9198686 | biostudies-literature