Colorectal cancer (CRC) is the third leading cause of new cancer cases and the second leading cause of cancer-related deaths worldwide. Current therapeutic modalities for CRC include surgical resection, intravenous chemotherapy (IVC), radiotherapy, immunotherapy, targeted therapy and their combinations. As a mainstream systemic treatment for CRC, IVC leads to widespread drug distribution but relatively low intratumoural drug accumulation. Compared with IVC, transarterial infusion chemotherapy (TAIC) involves selective arterial catheterisation to deliver chemotherapeutic agents directly to the tumour feeding vessels. Hepatic tumours receive their blood supply predominantly through branches of the hepatic artery. Hepatic artery infusion chemotherapy (HAIC) yields significantly superior outcomes compared with IVC and is currently widely employed for the treatment of primary and secondary hepatic malignancies. HAIC in combination with IVC can offer long-term durable disease control in the clinical treatment of liver cancer compared with IVC. CRC is also predominantly grown through angiogenesis. Therefore, we raise the question whether sequential IVC administered after intensive TAIC achieves better clinical efficacy than IVC alone for the treatment of unresectable CRC (uCRC). However, no prospective clinical trials have been conducted to compare the efficacy of these two strategies. This prospective study was therefore designed to fill this clinical knowledge gap.

This is a prospective, multicentre, randomised, open-label clinical trial. The uCRC is defined as inability to achieve an R0 resection owing to locally advanced CRC with clinical T4 disease confirmed by MRI or CT and/or synchronous liver metastases. This study only includes microsatellite stable or proficient mismatch repair uCRC. A total of 50 eligible patients will be randomly assigned to either the IVC group or the TAIC group. Patients in the IVC group will receive FOLFOX (fluorouracil, leucovorin, oxaliplatin)-based IVC every 2 weeks for a total duration of 8 weeks. Patients in the TAIC group will receive FOLFOX-based TAIC at week 0 and week 4 and receive FOLFOX-based IVC at week 2 and week 6. For patients with colorectal liver metastases, cetuximab or bevacizumab will be administered according to the RAS and BRAF status and the primary tumour site. The primary endpoint is the objective response rate. This study is scheduled to commence on 10 January 2026, and complete follow-up on 31 December 2027. The first subject was enrolled on 20 March 2026. To date, one subject in the IVC group and six subjects in the TAIC group have been enrolled.

The present study protocol has been approved by the Medical Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (ethical approval number 2025-268 KY). On completion of the study, data cleaning and analysis will be performed, and the results will be disseminated at academic conferences and in international peer-reviewed journals. This trial has been registered at ClinicalTrials.gov. The statistical analysis plan will be finalised and approved before the database lock. The final version is retained in the study documentation and will be made available to support the transparency and interpretation of the study results.

NCT07333053.

This study examined social determinants and structural barriers to lung cancer outcomes in Kern and Fresno counties, California, and co-developed a multilevel intervention strategy informed by community perspectives.

Engaging stakeholders through group model building (GMB) to elicit their knowledge to build a system dynamics (SD) simulation model for intervention strategy design.

We identified and trained four community members from two community-based organisations in Central Valley, California, to help recruit GMB participants. 14 community members representing patient advocacy organisations, cancer survivors, clinicians, caregivers, public health professionals, medical interpreters, housing, agriculture, sanitation, healthcare payer organisations and local policymaking sectors were recruited.

The GMB protocol consisted of two in-person and four virtual workshops from 22 August to 11 November 2024. The SD simulation model was built with iSee System’s Stella Architect SD modelling software (V.4.0).

The 181 variables suggested by the GMB workshop participants were categorised into 3 themes and 13 subthemes, which shaped the system boundary and model structure. 7 of the 16 intervention scenarios tested showed a cumulative reduction in the at-risk population and increases in screening, diagnoses, treatment and cancer-free survival. Participants selected a multilevel strategy focused on expanding public health and insurance education and advocating for air pollution-related screening within existing protocols.

Community engagement is essential for understanding lung cancer disparities and designing practical multilevel interventions. Scenario testing enables informed planning to improve long-term population health outcomes.

Health-related quality of life (HRQoL) assessments are a cornerstone of outcome evaluations for patients with cancer. The aim of this project was to assess patients with cancer in Lubumbashi/Democratic Republic of the Congo and: (1) evaluate what constitutes a clinically important health problem, (2) evaluate HRQoL and (3) compare HRQoL to controls.

Cross-sectional, prospective study.

Patient recruitment took place in 12 hospitals in Lubumbashi.

Inclusion criteria were a secured diagnosis of cancer, aged 18 years and above, no serious cognitive impairments.

(1) Semi-structured interviews with patients and healthcare professionals were conducted to investigate aspects of clinical importance. (2) The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was employed to quantitatively assess HRQoL; (3) an exploratory comparison of HRQoL data to Spanish controls, multinational reference data and the European general population data is performed.

(1) 20 patients (x-age=55.0 years; 70.0% female) and 10 healthcare professionals were interviewed. Social isolation, need for help/care and worries were frequently mentioned aspects making a health problem clinically important. (2) 103 patients (x-age=54.0 years; 67.0% female) with various cancer types were assessed. The prevalence of clinically important problems ranged from 26.2 % for fatigue to 94.1% for financial problems. (3) Compared to matched Spanish controls (n=207), symptom burden was more pervasive (OR 1.18 for insomnia to 28.0 for financial problems) than functional health limitations (max. OR 2.12 for role function). While adjusting HRQoL scores for age, sex, comorbidities and treatment intention decreased effect sizes of score difference across countries for 14 out of 16 scales, statistically significant differences across countries (p<0.05) remained for ten scales even after adjusting for covariates.

Clinical characteristics, aspects of clinical importance and HRQoL profiles of patients with cancer in Lubumbashi were reported. Aspects of clinical importance were identified, whereas a high symptom burden was reported by patients with cancer in Lubumbashi. Enhancing symptom management in Lubumbashi may alleviate symptom burden of patients with cancer.

Oligoprogressive disease (OPD) is a clinically significant pattern of progression observed in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer treated with endocrine therapy (ET) and cyclin-dependent kinase (CDK) 4/6 inhibitors. Stereotactic ablative body radiotherapy (SABR) is an emerging strategy that may ablate resistant subclones and prolong the benefit of systemic therapy. The AVATAR-II trial investigates whether the addition of SABR to continued systemic therapy can delay the need to change treatment strategy.

AVATAR-II is a multicentre, randomised, open-label, phase II randomised controlled trial enrolling 74 patients with histologically confirmed ER-positive, HER2-negative advanced breast cancer and 1–5 sites of extracranial OPD. Eligible patients must have demonstrated clinical benefit (stable disease or partial response) from ET and CDK4/6 inhibitors for at least 6 months prior to randomisation. Participants will be randomised 1:1 to either SABR to all OPD sites with continuation of current systemic therapy (Arm A) or physician’s choice of systemic therapy (Arm B). The primary endpoint is time to treatment failure, defined as progression not amenable to SABR, cessation of systemic therapy or death. The secondary endpoints include progression-free survival (PFS), PFS2, overall survival, treatment-related adverse events and patient-reported quality of life using the Functional Assessment of Cancer Therapy–Breast score.

This study received ethical approval from the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC), under approval number 25/45 and HREC reference HREC/105165/PMCC. Results of the study will be disseminated via peer-reviewed presentation at scientific conferences and open-access publication.

NCT06882499.

More than 5 million people in Germany are living with cancer or a history of cancer, 40% of them aged 75 years or older. Cancer and its treatment may lead to reduced physiological reserves, multiple somatic comorbidities and a combination of functional and psychosocial health problems in addition to the long-term and late effects of cancer and its treatment. Therefore, providing tailored care and support through an interdisciplinary care network is crucial. The aim of the IMPULS-A (Implementation of a Support Programme for Long-Term Cancer Survivors in Old Age) study is to evaluate an innovative survivorship programme designed to address the specific needs of older cancer survivors by improving access to regional care networks.

IMPULS-A is a prospective, two-arm, randomised controlled trial. Altogether, n=724 cancer survivors ≥70 years, who have completed the course of first line/primary treatment, with an expected lifespan of >3 years, identified support needs and live in proximity (≤100 km) of the National Center for Tumor Diseases Heidelberg, Germany, will be randomly allocated (1:1) to an intervention or control group. All eligible participants complete study evaluation questionnaires— either via LimeSurvey or paper-based — at three time points: T0 (at randomisation), T1 (T0+9 months) and T2 (T0+18 months). The primary outcome is health literacy. Secondary outcomes are digital health literacy, quality of life, effects on preventive health measures and healthcare utilisation, personal resources, treatment satisfaction, acceptability, appropriateness and feasibility of the survivorship care model and support needs of relatives in the long-term survival phase. For participants in the intervention group, a care navigator provides appropriate referrals and information based on a biannual biopsychosocial screening. Participants with complex needs are reviewed and discussed in an interdisciplinary survivor board. Participants in the control group receive the current standard treatment. Data analysis will be performed according to the intention-to-treat principle. The primary hypothesis will be analysed using a multilevel model. Missing values will be handled using the mixed models for repeated measures method. Additionally, qualitative, semi-structured interviews with patients from both study arms will explore which aspects are important to older people in relation to a life worth living after cancer.

Written informed consent will be obtained from all participants prior to study enrolment. The protocol, informed consent forms and information letters have been approved by the Ethics Committee of the Medical Faculty of Heidelberg University (S-692/2024), the Ethics Committee of the State Medical Association of Baden-Württemberg (B-F-2025-056) and the Ethics Committee of the State Medical Association of Rhineland-Palatinate (2025–18207). The study is conducted in accordance with the current version of the Declaration of Helsinki. Study results will be disseminated through publication in peer-reviewed journals and presentations at relevant scientific congresses and conferences.

ISRCTN14717755.

Sinonasal carcinomas are rare malignancies with an overall poor prognosis. These tumours arise in close proximity to vital structures, critical organs and cranial nerves involved in essential sensory and endocrine functions. Although multimodal treatment strategies combining surgery and radiotherapy (RT) are required to maximise the chances of cure while sparing surrounding tissues and reducing the risk of recurrence, they are associated with substantial cumulative morbidity. Building on high conformality and steep gradients of modern dose-painting RT, multidisciplinarity can be exploited on technical inter-disciplinary aspects. In particular, minimally morbid endoscopic endonasal multi-block surgery (EES), together with accurate histosurgical mapping, can be leveraged to individualise target tumour subvolumes delineation by risk level to avoid unnecessarily large irradiation and reduce the morbidity of RT while maintaining or improving local tumour control.

We designed a randomised multicentre phase II study to assess whether EES-based histosurgical mapping delineation and optimisation using a dose-painting approach can reduce treatment-related toxicity compared with standard intensity-modulated RT using conventional delineation in sinonasal carcinomas. The primary endpoint is the proportion of patients free from severe clinically significant radiation-induced toxicity involving the nasal mucosa, eyes, auditory system, endocrine system and/or brain within 3 months following RT completion. Secondary objectives include assessing the proportion of patients free from severe toxicities at 12 months, tumour control, quality of life, tolerance profile, RT plan quality and the association of histoclinical characteristics and radiomic features with toxicities. To ensure tumour control and avoid quality biases on toxicity outcomes, multidisciplinary volume delineation with the surgeon, as well as prospective individual case review (ICR) of the first 2 cases for each centre and both technique arms, and retrospective ICR for all cases, will be conducted.

Eligible patients will be 1:1 randomised between dose-painting based on histosurgical mapping (experimental arm) or standard delineation/optimisation (control arm), with stratification according to RT modality (photons or protons). We plan to enrol 52 patients. RT will start no earlier than 4 weeks and no later than 8 weeks after surgery, and will be delivered over a 7-week period. Patients will be followed-up for 18 months after completion of RT. We hypothesise that dose-painting RT, which relies on extensive interdisciplinary optimisation, will enable a selective de-escalation of irradiated volumes, which should translate into lower treatment-related toxicities.

Ethical approval was obtained from the Comité de Protection des Personnes Nord-Ouest IV (N°ID-RCB: 2022-A02011-42; cppnordouestiv@univ-lille.fr) on 12 April 2023, and authorisation from the National Agency for Medical and Health Products Safety on 15 May 2023. The most recent amendment (V2) was approved on 25 January 2024. Written informed consent will be obtained from all participants. Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors guidelines.

NCT05943119.

Oral potentially malignant disorders (OPMDs) and oral squamous cell carcinoma (OSCC) present a remarkable public health challenge worldwide. They are the leading causes of cancer-related morbidity and mortality in low-resource regions. In rural and underserved populations, access to diagnostic facilities is limited, and delays in confirmation often result in late-stage presentations. Field screening camps frequently serve as the first and sometimes only point of contact for many at-risk individuals; however, conventional cytology relies on laboratory infrastructure and specialist review, making same-visit diagnoses unfeasible. Recent advances in artificial intelligence-driven systems have created opportunities for point-of-care (PoC) diagnosis, enabling real-time disease detection and triage directly in community settings. This study aims to develop and clinically validate a convolutional neural network (CNN)-enabled PoC cytology device for real-time screening of OPMDs such as leukoplakia, oral submucous fibrosis, erythroplakia and OSCC in community field settings, following Standards for Reporting Diagnostic Accuracy Studies 2015 (STARD) and Standard Protocol Items: Recommendations for Interventional Trials 2013 (SPIRIT) guidelines.

This diagnostic accuracy study will evaluate an artificial intelligence (AI)-based PoC cytology screening tool for OPMDs and OSCC. A total of 900 participants (360 retrospective, 540 prospective) will be included to ensure adequate representation of normal, OPMDs and OSCC cases for both model development and clinical validation. Retrospective smears will be used to train and internally validate a deep learning CNN to classify smears as low-risk or high-risk. All slides will be independently reviewed by two blinded cytopathologists, with a third adjudicator resolving disagreements; inter-rater reliability will be assessed using Cohen’s kappa. Prospective validation will be evaluated in patients with clinically suspicious lesions against AI predictions with cytopathologist review and histopathology when available. Diagnostic performance will be assessed using sensitivity, specificity, positive and negative predictive values and area under the receiver operating characteristic curve, which will be calculated. Secondary outcomes are concordance with expert cytology, turn-around time and operational feasibility.

The protocol adheres to the Central Ethics Committee on Human Research ethical guidelines and has received institutional ethical approval from Datta Meghe Institute of Higher Education and Research (Deemed University) with the reference no. DMIHER (DU)/IEC/2024/18. Written informed consent will be obtained before recruitment.

The results will be published in peer-reviewed scientific journals and presented at national and international conferences.

CTRI/2025/01/079408.

Pain is one of the most prevalent symptoms among patients with cancer, and its presence and severity provide important prognostic information regarding survival. Patients with cancer pain experience a decline in their overall quality of life, along with a corresponding reduction in physical, cognitive, emotional and social functioning. Symptom management based on dynamic patient-reported outcomes (PROs) is recognised as the optimal ‘patient - centered’ healthcare model. However, clinical trial evidence on symptom management for patients with cancer pain remains insufficient. Therefore, we plan to conduct a randomised controlled trial to evaluate the effect of a PRO-based symptom monitoring response programme on pain intervention in patients with cancer in pain.

This study will recruit 116 patients with cancer in pain from our hospital. They will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. When a patient in the intervention group reports target symptoms (pain Numerical Rating Scale (NRS) >3, emotional screening Patient Health Questionnaire-4 Score >5 or nutritional screening NRS2002 Score ≥3), they will receive stratified symptom management based on PROs. A specialist physician will make adjustments according to symptom severity. Patients in the control group will not trigger alerts and will continue to follow the standard symptom management process. All patients will undergo a baseline assessment on the day of enrolment. The control group will receive routine outpatient management, and follow-ups will be conducted via telephone or online at 1 week, 2 weeks and 1 month after discharge. All patients will be followed up until 3 months after enrolment, disease progression, achievement of a pain-free state or death, whichever occurs first. The primary outcome measure—the effective rate of pain control—will be statistically analysed to compare differences between the intervention and control groups.

This study was approved by the Ethics Committee of Chengdu BOE Hospital on 14 August 2025 (approval No.: 2025052) and subsequently amended on 14 January 2026 (approval No.: 2026006). The manuscript is based on V.2.0 of the study protocol dated 14 January 2026. The study results will be disseminated in peer-reviewed journals and presentations at academic conferences.

ChiCTR2500114591

Breast cancer is the most common cancer in women in the UK. For women who have early-stage oestrogen-receptor positive (ER+ve) disease, daily oral adjuvant endocrine therapy reduces risk of recurrence. Recently, CDK4/6 inhibitors, a form of biological therapy, have been approved for use alongside endocrine therapy. However, trial data suggest there may be challenges with adherence to CDK4/6 inhibitors. This study aims to explore the experiences of adherence and support needs of women who have been prescribed CDK4/6 inhibitors for early ER+ve breast cancer. It will also co-develop an intervention to support women with adherence to these drugs alongside endocrine therapy through an evidence-based, theory-informed and patient-centred approach.

The SWEET-PLUS study has three phases. Phase I uses semi-structured interviews or focus groups to explore the experiences of women with early breast cancer who have been prescribed CDK4/6 inhibitors. It will also explore their support needs and experiences of adherence. Phase II involves interviews or focus groups with healthcare professionals who support CDK4/6 inhibitor prescription and associated care to understand the existing support and unmet needs. Phase I and II findings will inform phase III, which comprises workshops and user testing interviews to co-develop an intervention to support women with adherence to CDK4/6 inhibitors alongside endocrine therapy. This will be delivered as an additional module prototype designed for future integration into the existing HT&Me intervention, which supports women with adherence to endocrine therapy.

Data from phases I and II will be analysed using a framework approach-based thematic analysis. Phase III data will be analysed through content analysis.

SWEET-PLUS received ethical approval from the National Health Services (NHS) Health Research Authority (Cambridge East Research Ethics Committee (25/EE/0220)). Research findings will be disseminated through peer-reviewed journal articles and via international and national conferences. Further dissemination will be guided by patient and public involvement.

To estimate the item-level conditional association network of depression, anxiety and stress symptoms in patients with non-Hodgkin’s lymphoma (NHL) during a prespecified chemotherapy intercycle period and to identify symptoms with comparatively high expected influence, bridge expected influence and predictability.

Multicentre cross-sectional study.

Oncology departments of four tertiary hospitals in Jiangsu Province, China, from October 2024 to June 2025.

A total of 798 adults with pathologically confirmed NHL were assessed during the prespecified chemotherapy intercycle period.

The 21 items of the Depression Anxiety Stress Scales-21 (DASS-21) were modelled as nodes in a regularised partial-correlation network. Primary network measures were edge weights, expected influence and bridge expected influence; secondary measures were node predictability and bootstrap indices of accuracy and stability.

The strongest conditional association was between difficulty initiating tasks (D2) and lack of enthusiasm (D5; edge weight=0.282). Irritability (S7; expected influence=1.106), depression/dejection (D4; 1.065) and nervous energy (S3; 1.051) had the highest expected influence and also the highest bridge expected influence (0.972, 0.803 and 0.720, respectively). Trembling (A3; predictability=0.561), irritability (S7; 0.481) and intolerance of hindrance (S6; 0.476) had the highest predictability. Correlation-stability coefficients for expected influence and bridge expected influence were both 0.67.

Irritability, depression/dejection and nervous energy showed comparatively high signed connectivity within and across the prespecified DASS-21 domains, while the D2–D5 pair had the strongest conditional association. These cross-sectional findings are descriptive and hypothesis-generating and do not establish temporal, causal or treatment effects.

The first therapeutic assessment of locally advanced (LA) head and neck squamous cell carcinomas (HNSCCs) is often performed 10–12 weeks after the end of chemoradiotherapy as a result of the delayed action of radiotherapy. Diagnostic uncertainty between persistent disease and treatment-related changes (oedema, necrosis) can delay confirmation of residual cancer. According to data in the literature, a correlation exists between the detection of circulating tumour DNA (ctDNA) at the end of chemoradiotherapy treatment and residual disease. However, additional data are required before this molecular tool can be used in routine clinical practice. The aim of this clinical trial (NeckTAR-IN) is to assess the usefulness of ctDNA to detect residual disease 3 months after the end of chemoradiotherapy among patients with LA HNSCC.

At M3, objective response (clinical and radiological) will be set against the detection or not of ctDNA in the blood. This is an interventional, multicentre, prospective trial, ancillary to the NeckTAR study. All the patients included in the NeckTAR study are eligible for the NeckTAR-IN study. We expect to enrol 59 patients in this ancillary trial. A blood sample will be taken 1 month and 3 months after the end of chemoradiotherapy. Approval from the ethics committee was granted on 29 August 2025.

The study protocol obtained approval from the French Ethics Committee (N°25.02461.000435). The results will be published in scientific journals and presented at conferences.

NCT07178847.

Cancer is the most common cause of disease-related mortality in children, highlighting the urgent need for improved care in this population. It is estimated that >15% of children diagnosed with cancer harbour a germline pathogenic variant in a cancer predisposition gene which confers an increased risk to develop cancer. There are over 100 genes associated with cancer predisposition syndromes (CPSs) and greater availability and acceptability of genetic testing in the last decade has facilitated their recognition in childhood. However, individually, each of these CPSs is rare, impeding robust research and advancement of clinical care. Once a specific CPS is diagnosed, current recommendations for clinical care are based primarily on expert consensus with a ’one size fits all’ approach to management. Detailed knowledge of genotype-phenotype associations and the impact of genetic modifiers is lacking, and due to strong ascertainment bias of children already diagnosed with cancer predominantly being tested for a CPS, the true cancer risk is likely overestimated.

The Childhood Cancer Predisposition Study (CCPS) is a multi-centre registry and biorepository for children and adolescents aged 0–21 years with a clinical or molecularly confirmed CPS and their family members (NCT04511806). The study objectives are to characterise the natural history of each CPS, correlate the natural history phenotype with CPS genotype, evaluate the efficacy of standard surveillance strategies and allow future investigation into the feasibility and effectiveness of novel surveillance strategies. The principal study question is whether adherence to recommended tumour surveillance guidelines is associated with earlier detection of tumours and/or improved survival. We will also address what barriers exist that prevent adherence to surveillance guidelines. Data collected from primary subjects includes detail about the CPS, genomic data, cancer history and family cancer history, as well as information about tumour surveillance. Required biospecimen collection includes germline DNA samples, with optional collection of serial blood and stool samples. Planned enrolment is 1050 primary subjects.

CCPS was reviewed and approved by a central IRB (WCG IRB 2020P002450) and the Research Ethics Board at The Hospital for Sick Children in Toronto (1000072286). Written informed consent is obtained from all participants. Data and specimens are available to qualified investigators by request to address specific research questions through a standardised research application process. In addition, de-identified data are available through the Pediatric Cancer Data Commons for exploration. Analysed data will be disseminated in peer-reviewed publications and at conferences including meetings inclusive of patient and family advocacy groups.

NCT04511806.

Up to 40% of women with breast cancer will require a mastectomy, and breast reconstruction is routinely offered to restore symmetry. While not all women want, or are suitable for, breast reconstruction, many want to be symmetrical following breast cancer surgery. For these women, contralateral mastectomy for ‘flat symmetry’ is a good alternative, but in the UK, access to contralateral ‘symmetrising’ mastectomy (CSM) is highly variable. Many women seeking this option describe feeling frustrated, unsupported and having to ‘fight’ to access care, while clinicians express concerns about decisional regret. The FLAME (FLat symmetry After Mastectomy for brEast cancer) study aims to work with key stakeholders to co-develop a consensus-based pathway to improve access and outcomes for women seeking CSM as an alternative to breast reconstruction after a unilateral mastectomy for breast cancer.

Pathway development will be underpinned by the Medical Research Council (MRC) framework for the development of complex interventions, informed by the Behaviour Change Wheel and Capability, Opportunity, Motivation—Behaviour framework, complemented by Intervention Mapping. There will be six key stages: (1) creation of a logic model of the issues that need to be addressed with the CSM pathway using a systematic literature review, national practice surveys and qualitative interviews with key stakeholders; (2) definition of the logic model of change objectives (performance objectives, change determinants and change objectives); (3) pathway design informed by appropriate behaviour change techniques; (4) co-development of the pathway in a co-design workshop involving key stakeholders; (5) co-development of an implementation plan and (6) future evaluation.

Ethical approval has been obtained from the University of Bristol Research Ethics Review Committee (ref: 27961). Written and verbal informed consent will be obtained from all participants before the interview study and again from individuals participating in the workshop. Findings will be presented at national/international meetings and published in peer-reviewed journals. Dissemination materials will be co-produced with key stakeholders and shared widely with professional associations and patient support organisations to promote uptake and implementation.

Hepatocellular carcinoma is the sixth most common malignancy worldwide, with immune checkpoint inhibitors transforming treatment paradigms despite modest response rates of approximately 30%. Emotional distress, encompassing depression and anxiety symptoms, affects 30–50% of cancer patients and may influence immunotherapy efficacy through immune system modulation. Recent studies in lung cancer, gastric cancer and melanoma demonstrate associations between pretreatment emotional distress and worse immunotherapy outcomes. However, this relationship remains unexplored in patients with hepatocellular carcinoma, who may be particularly vulnerable due to underlying chronic liver disease and associated stigma. This study protocol describes a prospective investigation of the association between emotional distress and immune checkpoint inhibitor efficacy across different hepatocellular carcinoma treatment settings.

This multicentre, prospective, observational cohort study will enrol 700 patients with hepatocellular carcinoma across three cohorts: unresectable disease receiving first-line therapy (n=400), adjuvant therapy following curative resection (n=200) and neoadjuvant therapy with conversion intent (n=100). Three tertiary hospitals in China will serve as study sites, with recruitment commencing in October 2024 and study completion anticipated by October 2027. Emotional distress will be assessed using validated self-report measures (Patient Health Questionnaire-9, Generalised Anxiety Disorder 7) and clinician-administered scales (Hamilton Depression Rating Scale-17, Hamilton Anxiety Rating Scale), with comprehensive biomarker analysis including stress hormones, inflammatory cytokines and immune markers. Primary endpoints are cohort-specific: progression-free survival in Cohort 1, disease-free survival in Cohort 2 and pathological complete response rate in Cohort 3. Secondary endpoints include overall survival, objective response rate, quality of life and biomarker correlations. Statistical analysis will employ Kaplan-Meier survival analysis and Cox proportional hazards modelling, with participants followed for up to 36 months.

The study has received ethical approval from the Medical Ethics Committee of the First Affiliated Hospital of Guilin Medical University (LXIIT2024051), the Ethics Committee of Shaoyang Central Hospital (SYCH2025012) and the Ethics Committee of the Second Affiliated Hospital of Guangdong Medical University (PJKT2025035), and complies with Declaration of Helsinki guidelines. Results will be published in peer-reviewed journals and presented at international conferences.

NCT07141056.

To identify the latent profiles of health behaviour abilities among patients with haematological malignancies and to explore the underlying population heterogeneity and influencing factors.

A cross-sectional study conducted between October and December 2024.

Data were collected from three provincial hospitals in China.

A total of 486 hospitalised patients were recruited.

Data were collected using a demographic questionnaire, the Sense of Coherence Scale-13, the Perceived Social Support Scale and the Self-rated Abilities for Health Practices Scale. Latent profile analysis was performed to identify distinct classifications of health behaviour abilities and multivariate logistic regression was employed to determine the influencing factors.

The mean score of health behaviour abilities among the participants was 47.96 (SD 23.29). Three profiles were identified, showcasing substantial population heterogeneity: ‘exercise-weak survival profile’ (41%), ‘exercise-deficient developmental profile’ (45%) and ‘balanced-robust profile’ (14%). Multivariable regression revealed that age, education level, social support, financial toxicity and psychological distress were influencing factors determining profile membership.

Health behaviour abilities in patients with haematological malignancies were at a low level with three distinct latent profiles. Clinical healthcare providers should implement targeted interventions based on the characteristics of patients’ health behaviour abilities to enhance their self-management capabilities.

Cancer registries remain the gold standard for global cancer monitoring, yet complementing them with electronic health records and claims can significantly enhance the understanding of the cancer burden by providing a more complete picture of the patient journey. The main aim of this project is to serve as a proof of concept for using real-world data mapped to the Observational Medical Outcomes Partnership (OMOP) common data model (CDM) to monitor cancer epidemiology over time and characterise patients’ clinical history and outcomes.

This study will be conducted as an observational cohort study using a multinational network of large real-world data sources mapped to the OMOP CDM. Electronic health records (EHR) from primary and secondary care, health insurance claims and cancer registry data will be included. To date, 20 databases from 16 countries, mainly from Europe but also North America and Asia, have committed to participate in the project.

We will investigate the temporal trends in incidence, prevalence and survival of 36 cancers across haematopoietic and solid tumours from 2000 (or the start of accurate data if later) to the last year with complete data. Data from all individuals registered in each of the participating data sources will be eligible for inclusion in the study. For primary care EHR and claims, individuals will be required to have at least 1 year of prior observation to ensure the identification of incident cases and adequate capture of patient characteristics. We will estimate crude and age-standardised incidence and 5-year partial prevalence. Additionally, we will estimate crude and age-standardised overall survival at 1, 5 and 10 years for the total study period and by diagnosis year groups defined according to data availability. All study objectives will be investigated at the database level, with results stratified by age and sex. For incidence and survival analyses, additional stratifications will be performed by clinical conditions and smoking status (where available). We will use the National Cancer Institute (NCI) Joinpoint Regression Programme to model overall trends in cancer incidence and the NCI JPSurv software to estimate trends in survival. Finally, we will characterise individuals diagnosed with an incident cancer based on demographics, clinical conditions and medication use at different time windows.

Findings will be presented separately for each database and further summarised through descriptive aggregation by country and data source type.

Each data partner will obtain study approval from their local institutional review boards prior to study execution. Distributed queries will be employed, whereby standardised analytical code is shared and run at each site locally. Deidentified, aggregated results will be returned from all participating sites. A minimum cell count of five will be used when reporting results, depending on each collaborator’s data governance requirements.

All study code will be publicly available, and findings will be submitted to open science journals to promote transparency and reproducibility.

To assess gender-related differences in patient-reported experiences across the cancer care pathway in Switzerland among patients with non-sex-specific cancers.

Multicentre cross-sectional survey study.

Secondary and tertiary oncology care across 21 public and private hospitals in Switzerland, covering all linguistic regions.

Adult patients (≥18 years) with a confirmed diagnosis of cancer who received oncological care in participating centres and completed a standardised patient experience questionnaire. Of 4408 respondents included in the analysis, both men and women with non-sex-specific cancers were analysed. Patients with sex-specific cancers were excluded.

None

The primary outcome was the overall rating of cancer care (0–10 scale). The secondary outcomes were specific patient experiences in the pretreatment phase (consultations before the diagnosis, diagnosis and decision-making), during treatment (inpatient and outpatient care, specific treatments and nurse consultations) and in the post-treatment phase (follow-up, home care and psychosocial support).

Women rated their overall care lower than men (8.9 vs 9.1 on a 0–10 scale, p

Persistent gender inequities in cancer care experiences were identified, pointing to systemic gaps in communication, information and support. Addressing these disparities through gender-sensitive care is crucial to ensuring equitable, patient-centred oncological care for all.

This study aimed to evaluate the knowledge, attitudes and practices (KAP) of Jordanian women regarding post-mastectomy breast reconstruction (PMBR), and to recognise key sociodemographic factors influencing these outcomes.

A descriptive cross-sectional study.

Community-based settings across Jordan, representing a general population sample.

A total of 752 adult women were enrolled in the study. Eligible participants were women aged 18 years or older who were living in Jordan. Recruitment took place across a variety of community settings. Data were collected on sociodemographic variables such as age, level of education, insurance coverage and any personal history of breast disease.

The primary outcomes were KAP related to PMBR, measured using a standardised, pretested Arabic questionnaire. Secondary outcomes included identifying sociodemographic factors associated with KAP.

Participants demonstrated moderate knowledge (56.2%), a generally positive attitude (48.6%) and moderate practice levels (42.0%) toward PMBR. Regression analysis indicated that age, level of education, insurance status and personal history of breast disease were significant predictors of KAP outcomes.

Awareness and use of PMBR among Jordanian women remain inadequate. These results highlight the need for culturally tailored educational initiatives, improved communication between patients and healthcare providers, and the establishment of national guidelines to facilitate informed decision-making. Further studies are warranted to identify barriers to PMBR uptake and to evaluate the impact of targeted awareness interventions.

Given the metabolic vulnerability of colorectal cancer (CRC) cells, periodic fasting-mimicking diets (FMDs) have emerged as a promising dietary strategy for improving clinical outcomes. Although preclinical studies have suggested that FMDs may suppress tumour growth and early-phase clinical trials have demonstrated their safety and feasibility, evidence regarding their effects on long-term survival outcomes in CRC remains limited because of certain constraints in patient cohorts and study designs.

This multicentre, prospective, randomised controlled trial will be conducted at six tertiary comprehensive hospitals in China. It is anticipated that 602 eligible participants with clinical stage III CRC will be recruited. Participants will be randomly assigned at a 1:1 ratio to either the FMD group or the control group. After the 4-month dietary intervention, participants will continue to be followed up for 3 years. The primary outcome is 3-year disease-free survival. Participant enrolment began in June 2022, and the study is expected to be completed in December 2027.

The study protocol was approved by the ethics committees of Zhongshan Hospital, Fudan University and other participating centres. The findings of this study will be disseminated through publication in peer-reviewed journals and presentation at academic conferences.

NCT05384444.

Neighbourhood socioeconomic status (nSES) and built environment features strongly influence diet, physical activity and cancer screening adherence, potentially affecting colorectal cancer (CRC) incidence and prognosis. The aim of this study is to assess the association between neighbourhood obesogenic environments (eg, nSES, restaurant and retail food indices, recreational facilities, and business district residence) and CRC risk and mortality.

A secondary data analysis was performed using prospectively collected data from the Southern Community Cohort Study.

12 states in the Southeastern USA.

We analysed data from 70 519 participants enrolled in the Southern Community Cohort Study.

The primary outcomes in this study are CRC risk and mortality.

We used multivariable Cox proportional hazards models, adjusting for individual-level factors to investigate neighbourhood-level risk factors associated with CRC risk and mortality. We further performed race-stratified analyses (Black/White) to examine potential disparities in CRC risk.

Among 70 519 participants (69.49% Black, 30.51% White), 927 (1.31%) were diagnosed with CRC (1.37% Black and 1.19% White participants). Of these, 255 (27.5%) died from CRC. Compared with participants residing in the highest (fifth) nSES quintile, those residing in the wealthier (fourth) quintile of nSES exhibited a higher CRC risk (adjusted HR (aHR) 1.27 (95% CI 1.03 to 1.57)). The Retail Food Environment Index was associated with an increased risk of CRC among participants residing in the fifth (wealthiest) nSES quintile (aHR 3.07 (95% CI 1.23 to 7.61) for Tertile 1 vs None; aHR 3.06 (95% CI 1.23 to 7.60) for Tertile 2 vs None). Similar associations were observed among both Black participants (aHR 3.65 (95% CI 1.19 to 11.20) for Tertile 1 vs None) and White participants (aHR 5.20 (95% CI 1.29 to 20.97) for Tertile 2 vs None) living in the same neighbourhoods, although these subgroup estimates should be interpreted cautiously due to wide CIs. Living in a low-walkability neighbourhood was associated with a higher risk of CRC (aHR 2.42 (95% CI 1.09 to 3.56)) among residents in the second-lowest nSES quintile, particularly among Black participants (aHR 3.41 (95% CI 1.29 to 9.02)). Compared with residents of the most walkable neighbourhoods, those in the least walkable (aHR 2.23 (95% CI 1.10 to 4.54)), below-average walkable (aHR 2.10 (95% CI 1.08 to 4.07)) and above-average walkable areas (aHR 2.33 (95% CI 1.24 to 4.39)) had significantly higher CRC mortality risk.

Our findings suggest that nSES and unhealthy food environments are associated with CRC risk, while less walkable environments were associated with higher CRC mortality. These findings highlight the need for a more detailed assessment of neighbourhood-level deprivation and support enhanced public policies targeting neighbourhood deprivation in low-income populations in the Southeastern USA.