Conectar
Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.
This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.
This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.
This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.
First post-contrAst SubtracTed (FAST) MRI, an abbreviated breast MRI scan, has high sensitivity for sub-centimetre aggressive breast cancer and short acquisition and interpretation times. These attributes promise effective supplemental screening. Until now, FAST MRI research has focused on women above population-risk of breast cancer (high mammographic density or personal history). DYAMOND aims to define the population within the population-risk NHS Breast Screening Programme (NHSBSP) likely to benefit from FAST MRI. The study population is the 40% of screening clients aged 50–52 who have average mammographic density (BI-RADS (Breast Imaging Reporting and Data System) B) on their first screening mammogram. DYAMOND will answer whether sufficient numbers of breast cancers, missed by mammography, can be detected by FAST MRI to justify the inclusion of this group in a future randomised controlled trial.
Prospective, multicentre, diagnostic yield, single-arm study with an embedded qualitative sub-study: all recruited participants undergo a FAST MRI. An internal pilot will assess the willingness of sites and screening clients to participate in the study. Screening clients aged 50–52, with a clear first NHSBSP mammogram and BI-RADS B mammographic density (by automated measurement) will be invited to participate (recruitment target: 1000). The primary outcome is the number of additional cancers detected by FAST MRI (missed by screening mammography). A Fleming’s two-stage design will be used as this allows for early stopping after stage 1, to save participants, funding costs and time continuing to the end of the study if the question can be answered earlier.
The NHSBSP Research and Innovation Development Advisory Committee and the Yorkshire and Humber–Sheffield Research Ethics Committee (23/YH/0268, study ID (IRAS): 330059) approved this research protocol. Participation involves a two-stage informed consent process, enabling screening for eligibility through automated mammographic density measurement. Patients with breast cancer helped shape the study design and co-produced participant-facing documents. They will disseminate the results to the public in a clear and meaningful way. Results will be published with open access in international peer-reviewed scientific journals.
Although lung cancer remains the leading cause of cancer deaths in the US, recent advances in early detection and treatment have led to improvements in survival. However, there is a considerable risk of recurrence or second primary lung cancer (SPLC) following curative-intent treatment in patients with early-stage non-small cell lung cancer (NSCLC). Professional societies recommend routine surveillance with CT to optimise the detection of potential recurrence and SPLC at a localised stage. However, no definitive evidence demonstrates the effect of imaging surveillance on survival in patients with NSCLC. To close these research gaps, the Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2) study will leverage real-world electronic health records (EHRs) data to evaluate surveillance outcomes among patients with and without guideline-adherent surveillance. The overarching goal of the PLuS2 study is to assess the long-term effectiveness of surveillance strategies in real-world settings.
PLuS2 is an observational study designed to assemble a cohort of patients with incident pathologically confirmed stage I/II/IIIA NSCLC who have completed curative-intent therapy. Patients undergoing imaging surveillance will be followed from 2012 to 2026 by linking EHRs with tumour registry data in the OneFlorida+ Clinical Research Consortium. Data will be consolidated into a unified repository to achieve three primary aims: (1) Examine the utilisation and determinants of CT imaging surveillance by race/ethnicity and socioeconomic status, (2) Compare clinical endpoints, including recurrence, SPLCs and survival of patients who undergo semiannual versus annual CT imaging and (3) Use the observational data in conjunction with validated microsimulation models to simulate imaging surveillance outcomes within the US population. To our knowledge, this study represents the first attempt to integrate real-world data and microsimulation models to assess the long-term impact and effectiveness of imaging surveillance strategies.
This study involves human participants and was approved by the University of Florida Institutional Review Board (IRB), University of Florida IRB 01, under approval number IRB202300782. The results will be disseminated through publications and presentations at national and international conferences. Safety considerations encompass ensuring the confidentiality of patient information. All disseminated data will be de-identified and summarised.
Cancer has impacted patients’ quality of life (QoL). Qigong, a type of mind-body exercise, has been adopted by some patients with cancer to improve their QoL. However, various lengthy questionnaires were used to assess Qigong’s effects which made data synthesis difficult. Therefore, a simplified Qigong QoL Questionnaire (3Q instrument) has been developed to assess cancer patients’ QoL when they practise Qigong. This study aims to validate this instrument and contribute to the standardisation and simplification of the outcome measures for the studies on Qigong.
A total of 173 patients with cancer practising Qigong in Australia and China will be recruited to evaluate QoL using the 3Q instrument and Functional Assessment of Cancer Therapy–General (FACT-G) questionnaire. SPSS Statistics V.29 software will be used for data analyses. Exploratory factor analysis will be conducted to identify the factor structures of the 3Q instrument. The internal consistency of the 3Q instrument will be evaluated by Cronbach’s alpha. Test–retest reliabilities will be confirmed by intraclass correlations. Content validity will be assessed by the Spearman’s correlation coefficient. Construct validity will be established through confirmatory factor analysis. Criterion validity will be assessed against FACT-G, and Spearman’s correlation coefficient will be adopted to calculate their correlations.
This study has been approved by the RMIT University Human Research Ethics Committee (HREC26229). The findings from the present study will be submitted to peer-reviewed journals for publication and/or presented at conferences.
Systemic therapies for advanced gastric cancer (GC), including chemotherapy, targeted therapy and immunotherapy, have evolved significantly in the past few years. The combination of immune checkpoint inhibitors (ICIs) and chemotherapy has become the standard first-line (1L) treatment for advanced gastric or gastro-oesophageal junction (G/GEJ) cancer, although there remains a need for improvement in efficacy. Fruquintinib, an oral and highly selective vascular endothelial growth factor receptor inhibitor, has shown a synergistic antitumour effect when paired with ICI or chemotherapy. Moreover, it has demonstrated a tolerable safety profile and high potential for synergy with chemotherapy or immunotherapy, suggesting that a combination of fruquintinib, sintilimab and oxaliplatin+capecitabine (CAPEOX) can be a promising treatment for locally advanced G/GEJ cancer. This phase 1b/2 study aims to investigate the safety and efficacy of the combination of fruquintinib, sintilimab and CAPEOX regimen as a 1L combination therapy for unresectable advanced or metastatic G/GEJ cancer.
The FUNCTION trial (NCT06329973) is a single-arm, prospective, multicentre, phase Ib/II clinical trial that will consist of a dose escalation phase and an expansion phase. The study is planned to be conducted at 16 public hospitals. A total of 70 participants will be enrolled, comprising nine in the dose escalation phase and 61 in the expansion phase. The dosing regimen during the dose escalation phase will include three different doses of fruquintinib (3 mg, 4 mg and 5 mg, per oral, once per day days 1–14) + sintilimab, 200 mg, intravenous, day 1 +oxaliplatin 130 mg/m2, day 1, intravenous, + capecitabine 800 mg/m2, per oral, twice daily, days 1–14, every 21 days. The recommended phase 2 dose (RP2D) and maximum tolerated dose will be determined in the escalation phase, and the RP2D will be used in the expansion phase. The primary endpoints will be the maximum tolerated dose and objective response rate; the secondary endpoints will include OS, progression-free survival, disease control rate, duration of response, surgical conversion rate and adverse events and identification of molecular biomarkers for efficacy. The results from this study will provide evidence for expanding the clinical applications of fruquintinib plus sintilimab and CAPEOX as a 1L combination therapy in metastatic or non-resectable, locally advanced G/GEJ cancer and lay the foundation for future large-scale clinical investigations.
This study will be conducted in full compliance with the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH) GCP (Good Clinical Practice, GCP) guidelines, the rules of the Declaration of Helsinki and ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting) Guidelines . The study protocol has received approval from the Henan Cancer Hospital ethical committee (Approval No. 2023-237-002). Written informed consent will be obtained from all patients prior to enrolment. For patients who have the mental capacity for informed consent, their consent for participation will be sought and will not be overridden by their family members. For patients who have impaired cognition, informed consent will be sought from their legally acceptable representative. On completion of the analyses, the study findings will be disseminated locally and internationally through manuscript publications in peer-reviewed journals and conference presentations.
This qualitative study aimed to address the following central research question: what are the key factors and behavioural trajectories influencing delayed medical care-seeking among participants with breast cancer-related lymphoedema (BCRL), and how do these factors operate across the stages of symptom perception, alertness and decision-making?
This qualitative study employed a phenomenological approach, with semistructured interviews conducted to explore participants' experiences.
A tertiary hospital located in North China.
18 patients with BCRL were recruited through purposive maximum variation sampling and interviewed in person between January and June 2023.
10 themes emerged and were categorised into three stages: (1) the perception stage (lack of disease knowledge, risk underestimation and symptom avoidance); (2) the alertness stage (failed self-management, negative coping and exposure to misinformation) and (3) the decision-making stage (financial burden, limited healthcare access, insufficient social support and fatalism). The average delay was 10.2 months, with prolonged delays (>12 months) linked to severe lymphoedema progression.
Delayed care seeking in BCRL is a multifactorial behavioural trajectory shaped by knowledge gaps, systemic barriers and psychosocial factors. Clinicians should prioritise early patient education and context-sensitive interventions to mitigate delays.
To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.
Two-arm cluster-randomised pilot trial: SIP SMART2 trial.
Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.
Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.
Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.
12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.
It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.
Chronic caregiving stress accelerates biological aging, reflecting disease risk and mortality; however, the underlying mechanisms are poorly understood. Epigenetic clocks, which can be estimated from levels of DNA methylation in a subset of cytosine-phosphate-guanine loci in the genome, have been proposed as a promising biological age estimator. The objectives of this scoping review are to systematically scope the literature on the effects of stress on biological ageing measured by epigenetic clocks in family caregivers of patients diagnosed with cancer.
This review will be conducted following Joanna Briggs Institute methodology based on Arksey and O’Malley’s and Levac et al’s framework and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for scoping reviews. Studies will be included if (1) the studies focus on unpaid family caregivers of patients diagnosed with cancer; (2) caregivers are adults (≥18 years of age) and (3) the study measured epigenetic clocks. The search will encompass literature and peer-reviewed literature in PubMed/MEDLINE (National Library of Medicine), Embase (Elsevier), Cochrane CENTRAL (Wiley & Sons), Web of Science: Core Collection (Clarivate Analytics), CINAHL (EBSCOhost) and PsycInfo (American Psychological Association).
Since the scoping review methodology focuses on published literature, this study does not require ethical approval. We will publish our findings in a peer-reviewed journal and plan to disseminate our work in conferences and scientific meetings.
Open Science Framework (https://doi.org/10.17605/OSF.IO/KW7RT).
In current clinical practice, breast cancer is treated according to hormone receptor and human epidermal growth receptor 2 expression (HER2) status, which play an important role in disease management and overall prognosis. Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-breast trials. Recent marketing authorisation for T-DXd has been granted from Health Canada for HER2-positive breast cancer who have received prior treatment with trastuzumab emtansine, or at least one prior anti-HER2-based regimen in the metastatic setting, or who have received a prior anti-HER2-based regimen in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy. T-DXd is also indicated for HER2-low unresectable and/or metastatic breast cancer (mBC) patients who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. However, there is a paucity of evidence assessing T-DXd in the real-world setting. As such, the overarching aim of this study is to generate Canadian real-world evidence on discontinuations and treatment modifications for patients with HER2+ and HER2-low mBC undergoing treatment with T-DXd.
This is a hybrid, longitudinal cohort study design leveraging patient support programme (PSP) secondary data with additional primary data collection to assess study treatment-related outcomes among patients with HER2+ and HER2-low mBC receiving treatment with T-DXd. Mainly, this study will leverage secondary data from the PSP, which will include clinical and demographic characteristics as well as duration, modification and intensity of treatment information for patients while enrolled in the PSP. These data will be supplemented with primary data, which will be collected via a patient questionnaire and include additional self-reported clinical and demographic characteristics not captured within the PSP, including follow-up data on therapies received, treatment discontinuation information after the PSP closure and frequency of CT scans and cardiac monitoring scans.
The study protocol was approved by the Advarra Institutional Review Board on 13 December 2023 (ID: D133HR00037). Findings will be disseminated by publication in peer-reviewed journals, through oral and poster presentations for various audiences, websites and scientific meetings. Written informed consent will be obtained from all patients prior to agreeing to participate in this study.
Participant recruitment for primary data collection began on 22 April 2024 and was completed on 8 October 2024. Primary data collection for follow-up will continue through up to 12 months after the date of the last enrolment.
Oesophageal squamous cell carcinoma (ESCC) ranks among the most aggressive malignancies and carries a poor prognosis. Lymphocytes play a key role in combating infections and suppressing tumourigenesis. Many studies have established a close association between lymphocyte depletion and adverse therapeutic outcomes in oesophageal cancer. Nevertheless, high-quality data validating the clinical efficacy and safety of lymphocyte-sparing thoracic radiotherapy regimens for ESCC remain scarce.
This prospective, open-label, randomised controlled trial aims to determine whether lympho-nTRT-ESO reduces the incidence of acute grade 3–4 lymphopaenia in patients with ESCC undergoing neoadjuvant chemoradiotherapy (nCRT), compared with conventional thoracic radiotherapy (RT). A total of 212 participants will be enrolled and randomly allocated in a 1:1 ratio to either the lymphocyte-sparing RT (RT) group or the conventional RT group. All patients will receive standardised nCRT, which will deliver a total dose of 41.4 Gy in 23 fractions. For the lymphocyte-sparing RT group, RT planning prioritises the planning target volume (PTV) coverage and conventional organ-at-risk (OAR) constraints while applying dose constraints to lymphocyte-related OARs (LOARs). These LOARs include the T1–T12 vertebral bodies, ribs, spleen and major cardiovascular structures (heart and large blood vessels), with optimisation performed only after PTV coverage and standard OAR constraints are satisfied.
This trial was approved by the Ethics Committee of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (RJ 2024–210) on 11 July 2024 and registered on ClinicalTrials.gov (NCT06596954) before participant recruitment. All participants should provide written informed consent to be eligible. We planed to publish the primary and secondary results of this study in scientific peer-reviewed journals and present at radiation oncology conferences.
The improved survival rates of children with cancer have heightened concerns about treatment-related chronic health conditions, including platinum-induced hearing loss (PIHL). Cisplatin and carboplatin, widely used in paediatric cancer therapies, frequently cause irreversible sensorineural hearing loss. PIHL affects 1.7–90.1% of patients exposed to these drugs, yet known risk factors—including age, cisplatin dosage, cranial radiation and co-treatment with ototoxic drugs—fail to fully explain interindividual variability. Genetic factors likely play a role in susceptibility to PIHL. Since genetic susceptibility in children may differ from adults, and given the critical window of auditory development, a focused investigation of paediatric genetic factors using quantitative methods is warranted to detect small to moderate effects and understand the polygenic nature of PIHL.
In this study, we will systematically review and conduct a meta-analysis of genetic polymorphisms associated with PIHL in individuals diagnosed before the age of 21 years. Following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, the review will include randomised controlled trials, cohort, case-control and cross-sectional studies that analyse the genetic influence on PIHL in paediatric populations treated with cisplatin and carboplatin. A comprehensive search of PubMed, EMBASE and Cochrane databases will be conducted, supplemented by backward citation searching. Data will be extracted on study design, treatment details, hearing loss assessment methods, genetic findings and covariates. We will use forest plots to present the results, and both Mantel-Haenszel fixed-effects model and random-effects model will be used for meta-analysis. Heterogeneity will be assessed with the I² index. The study will address potential heterogeneity, individual study quality, proportion of missing data and meta-analysis bias. The quality of the evidence of the meta-analysis will be assessed using the Grading quality of evidence and strength of Recommendations (GRADE) approach.
This systematic review will enhance our understanding of the genetic contribution to PIHL in children and serve as a basis for further research for improvement of personalised treatment strategies for paediatric cancer care.
CRD42024532664.
All the included patient’s data are already published with an ethics approval for each study, respectively. No original data will be collected.
The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.
The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.
The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.
The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.
A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.
This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.
CRD42023452537.
Immunotherapy combined with chemotherapy has shown potential in improving the pathological complete response (pCR) rate in luminal-type breast cancer. This study explores whether the addition of stereotactic body radiotherapy (SBRT) and the bispecific antibody AK112 (Ivonescimab) further enhances treatment efficacy.
This is a single-centre, prospective, phase II trial using Simon’s two-stage design to evaluate the efficacy and safety of neoadjuvant SBRT combined with Ivonescimab and chemotherapy. A total of 50 patients will be enrolled. The primary endpoint is pCR. Secondary endpoints include objective response rate, disease control rate, Residual Cancer Burden Index, 12-month event-free survival, safety and quality of life. Exploratory endpoints include six-point minimal residual disease (MRD) assessment. Data will be analysed using the Kaplan-Meier method and one-sided exact binomial test (alpha=0.05).
This study has been approved by the ethics committee of Hubei Cancer Hospital (Approval No.: LCKY2024011). Results will be disseminated through peer-reviewed journals and conference presentations.
Nasopharyngeal carcinoma (NPC) presents significant nutritional challenges during concurrent chemoradiotherapy, adversely affecting treatment outcomes and quality of life. Non-pharmacological interventions may help improve nutritional and immune status, reduce complications and enhance overall well-being. However, evidence of their effectiveness is scattered and inconsistent, and no systematic review has yet synthesised the evidence on their effectiveness. This protocol outlines a systematic review and meta-analysis to evaluate the impact of non-pharmacological interventions on nutritional status, immune function and complications in NPC patients undergoing chemoradiotherapy. The findings may contribute to clinical recommendations and support evidence-based decision-making in the supportive care of NPC patients.
This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. A comprehensive search will be conducted in MEDLINE, PubMed, CINAHL, EMBASE, Cochrane Library, Web of Science, ProQuest, China National Knowledge Infrastructure, Chinese Biomedical Literature Database and Wan Fang from November 2014 to November 2024. Search terms will include concepts related to NPC, nutrition, supplements, education, exercise, multimodal interventions and chemoradiotherapy. Only randomised controlled trials will be included. Two reviewers will independently screen studies, extract data and assess the risk of bias using the Cochrane Risk of Bias Tool V.2. Where appropriate, a meta-analysis will be performed using RevMan 5.4.
This systematic review does not directly involve the use of human beings; therefore, there is no requirement for ethical approval. Findings will be disseminated through peer-reviewed publications and in various media, such as conferences, congresses or symposia.
CRD42024571769
Advanced-stage hepatocellular carcinoma (HCC) with high tumour burden and portal vein tumour thrombus (PVTT) is usually associated with poor survival outcomes. Rapid tumour control usually benefits long-term outcomes, which could be hardly achieved by solely systematic targeted and immunotherapy in current guidelines. Hepatic arterial infusion chemotherapy (HAIC) is reported as an effective intervention for rapid decrease of tumour burden. In order to determine the role of HAIC in the comprehensive treatments, a target trial emulation study is conducted to compare the effectiveness and safety of HAIC in combination with lenvatinib and programmed death receptor-1 (PD-1) inhibitors (H+L+P) to that of lenvatinib and PD-1 inhibitors (L+P) in patients with advanced HCC exhibiting high tumour burden and PVTT.
This target trial emulation study will be conducted at nationwide, multicentre CHANCE registries in China. We aim to include at least 228 patients with advanced-stage HCC with high tumour burden (up-to-seven criteria out) and PVTT who received L+P with or without HAIC as the first-line treatment between January 2021 and December 2023. The study design adheres to the framework of target trial emulation. To mitigate biases, a stabilised inverse probability of treatment weighting will be conducted. Overall survival is defined as the primary endpoint. Secondary endpoints consist of progression-free survival, objective response rate and adverse events.
Our study was approved by the Medical Research Ethics Committee of the First Hospital of China Medical University, and the study protocol was also approved by the institutional review boards of participating centres. The ethics committee waived informed consent because the study was retrospective. The findings of this study will be submitted for publication in peer-reviewed journals and will also be shared at multiple conferences on interventional radiology and oncology, ranging from local to international.
Combined vascular endothelial growth factor/programmed death-ligand 1 blockade through atezolizumab/bevacizumab (A/B) is the current standard of care in advanced hepatocellular carcinoma (HCC). A/B substantially improved objective response rates compared with tyrosine kinase inhibitor sorafenib; however, a majority of patients will still not respond to A/B. Strong scientific rationale and emerging clinical data suggest that faecal microbiota transfer (FMT) may improve antitumour immune response on PD-(L)1 blockade. Early trials in melanoma with FMT and reinduction of immune checkpoint blockade (ICI) therapy in patients with anti-PD-1-refractory metastatic melanoma were reported in 2021 and demonstrated reinstatement of response to ICI therapy in many patients. Due to anatomical vicinity and the physiological relevance of the gut-liver axis, we hypothesise HCC to be a particularly attractive cancer entity to further assess a potential benefit of FMT in combination with ICI towards increased antitumour immunity. Additionally, HCC often occurs in patients with liver cirrhosis, where liver function is prognostically relevant. There is evidence that FMT may increase hepatic function and therefore could positively affect outcome in this patient population.
This prospective, multicentre, randomised, placebo-controlled, double-blind phase II clinical trial has been designed to assess immunogenicity and safety of FMT via INTESTIFIX 001 combined with A/B in advanced HCC in comparison to A/B with placebo. Primary endpoints are measured as tumour CD8+ T cell infiltration after 2 cycles of treatment with vancomycin, A/B+INTESTIFIX 001 in comparison to vancomycin-placebo, A/B+INTESTIFIX 001-placebo and safety of the therapeutic combination in advanced HCC. INTESTIFIX 001 is an encapsulated FMT preparation by healthy donors with a high alpha-diversity in their gut microbiome for oral administration, manufactured by the Cologne Microbiota Bank (CMB). Sample size was calculated to achieve a specific expected accuracy for the primary immunological endpoint. 48 subjects will be randomised to reach a goal of 42 usable measurements in the modified intention-to-treat set. Subjects will be randomised in a 2:1 ratio to A/B or placebo (28 A/B, 14 placebo).
The study was approved by ethics committee review and the German Federal Ministry of Drugs and Medical Devices. The trial is registered under EU CT no. 2023-506887-15-00. The outcome of the study will be disseminated via peer-reviewed publications and at international conferences.
There are estimated to be 3.4 million patients in the UK living after a diagnosis of cancer. We know very little about their quality of life or healthcare usage. Patient-reported outcome measures (PROMs) are tools which help to translate a patient’s quality of life into measurable categories, but how to do this at scale remains underexplored. The study employs a randomised design to assess different engagement strategies for optimising participation, data linkage and questionnaire completion in Northwest London and then nationally, with appropriate research approvals.
We have designed and implemented an online, patient-completed, randomised observational trial. We will pilot it in Northwest London before national roll-out, using initially the General Practice (GP) record of a cancer diagnosis and then exploring the use of social media. The primary objective is to explore the feasibility of recruiting participants via self-identification or contact from the primary care research network and obtaining consent to link participants’ PROMs responses to their cancer registry records. Data collection occurs through a secure platform, with participants directly responsible for data entry. There is no formal target sample size because this is a feasibility study, and we want to explore how many patients we can recruit. Analyses will be conducted using descriptive statistics, repeated measures multilevel modelling and machine learning techniques. If a substantial difference in responses between randomisation arms is detected, ineffective strategies will be removed. If no clear difference is observed, recruitment will continue with periodic reviews based on response rates and data completeness.
The Study Coordination Centre has obtained approval from the London—Surrey Research Ethics Committee and Health Research Authority. We will publish and disseminate the results in local, national and international meetings, in peer-reviewed journals, on social media and on websites.
It has been registered under ‘Investigating Digital Outcomes for Cancer Survivors in the Community’ (NCT06095024).
NCT06095024: Investigating Digital Outcomes for Cancer Survivors in the Community.
The main objective of this study was to explore and describe perceived risk of women towards Human Papillomavirus (HPV) infection and cervical cancer (CC) in Adama, Ethiopia. Perception of women towards CC screening was also investigated.
A qualitative exploratory, descriptive and contextual research design was employed. The health belief model (HBM) theoretical framework guided the study. Data were collected through focus group discussions (FGDs) using open-ended, unstructured questions and analysed using a theory-driven thematic analysis with the use of the key constructs of the HBM.
The study was conducted from 1 to 30 October 2023 at three selected public health facilities in Adama, where CC screening service is being offered.
Thirty (10 from each public health facility) 25–49 years women were purposefully selected and participated in the FGDs until data saturation was reached. Information-rich women, believed to have some awareness about the topics to be discussed and could have the ability to clearly articulate their experience during the FGDs, were selected.
There was low perceived susceptibility but high perceived severity of HPV infection and CC. Early detection of symptoms, getting treated in time and prevention of CC were the major perceived benefits recognised in the study. Fear of the result and negative influence from peers were perceived barriers identified. With regard to self-efficacy, all the participants had full confidence to be screened. Participants’ cues to action include recommendation from health workers and perceived bad experiences previously happened on others.
There was low perceived susceptibility but high perceived severity of HPV infection and CC. Awareness creation campaigns about HPV infection and CC are crucial.
Advanced or recurrent endometrial carcinoma (EC) represents a significant clinical challenge. This study aimed to evaluate patient (age and comorbidities) and disease (histological subtypes and stages) characteristics, treatment patterns and survival outcomes in a real-world French healthcare setting.
In this national, multi-centre, retrospective observational cohort study, 200 patients with advanced or recurrent EC receiving first- or second-line chemotherapy during the year 2019 were analysed. Data collected included baseline characteristics, treatment regimens, real-world progression-free survival (rwPFS) and overall survival (OS).
127 and 73 were included in the first and second lines, respectively. Endometrioid carcinoma was the most represented histological subtype (62.0%). Patients in the first line, of whom 31.5% had FIGO (Fédération Internationale de Gynécologie Obstétrique) IVB disease, mainly received a combination of carboplatin and paclitaxel (78.0%), while 131 patients receiving second-line therapy were mainly administered anthracycline (54.2%). Median rwPFS and OS were, respectively, 8.5 and 13.2 months for patients receiving first-line therapy and 4.0 and 9.4 months for patients receiving second-line therapy. In Cox analyses, a diagnosis of carcinosarcoma, the presence of liver metastases and stage IVB disease were associated with worse survival outcomes for patients recieving first-line chemotherapy. Non-platinum chemotherapy and liver metastases were associated with poorer survival in patients receiving second-line chemotherapy.
This study highlights the landscape of metastatic EC treatment in a real-world French setting before the availability of PD1 inhibitors, emphasising the discrepancy between clinical trial data and real-world outcomes. It underscores the necessity for further real-world studies to complement clinical trials for a comprehensive understanding of metastatic EC management.
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