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Telehealth-delivered exercise and nutrition intervention to improve outcomes in patients with early stage non-small cell lung cancer: protocol for the multicentre STARLighT phase II (neoadjuvant) and phase III (adjuvant) trial

Por: Avancini · A. · Giannarelli · D. · Ugel · S. · Mafficini · A. · Fiorini · P. · Scaglione · I. · Adamoli · G. · Borsati · A. · Belluomini · L. · Eccher · S. · Trestini · I. · Tregnago · D. · Sposito · M. · Insolda · J. · Schena · F. · Scarpa · A. · Derosa · L. · Milella · M. · Novello · S.
Introduction

In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC.

Methods and analysis

STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB–IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune–inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.

Ethics and dissemination

The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Trial registration number

Clinicaltrial.gov: NCT07042724.

Definition of predictive and prognostic immune biomarkers for salivary gland cancer from the intratumoural and systemic immune status: detailed protocol of the prospective, observatory ImmoGlandula study

Por: Donaubauer · A.-J. · Frey · B. · Agaimy · A. · Lange · F. · Mogge · L. · Fietkau · R. · Iro · H. · Munoz · L. E. · Weber · M. · Kesting · M. · Gaipl · U. S. · Haderlein · M. · Müller · S.
Introduction

Salivary gland carcinomas (SGC) are rare tumours. The term SGC is not more than an umbrella for a variety of histogenetically, morphologically and biologically distinct entities. Accordingly, SGCs have not been sufficiently investigated to date. Their rarity makes it difficult to reach high patient numbers for individual entities in clinical studies, leading to pooling patients with different histological subtypes to attain sufficient participants. The different histological subtypes of SGC differ significantly in their clinicopathological features, such as their grading, their occurrence and their outcome. SGCs are usually stratified into low-grade, intermediate-grade or high-grade tumours. In most kinds of SGC, specific targetable molecular markers are lacking. The inclusion of immunotherapy (IT), however, might improve the outcome of patients suffering from high-grade SGCs. In order to integrate IT as a therapeutic option for SGC and to facilitate therapeutic decisions based on tumour (immune) biology, predictive and prognostic immunological biomarkers are indispensable.

Methods and analysis

In this prospective study, 500 patients will be enrolled, who are distributed in three arms. The observational cohort includes patients with malignant salivary gland tumours, whereas patients with benign tumours of a salivary gland are grouped in the control group 1. In the control cohort, 2 patients do not have a salivary gland tumour but have a planned functional surgery of the nose or ear or a maxillofacial surgery. The local immune status from the tumour tissue and the microbiome will be sampled before treatment. In addition, the systemic immune status from peripheral blood will be analysed before and after surgery and after the adjuvant and definitive chemoradiotherapy, if applicable. Clinical baseline characteristics and outcome parameters will additionally be collected. Data mining and modelling approaches will finally be applied to identify interactions of local and systemic immune parameters and to define predictive and prognostic immune signatures based on the evaluated immune markers.

Ethics and dissemination

Approval from the institutional review board of the Friedrich-Alexander-Universität Erlangen-Nürnberg was granted in September 2023 (application number 23-292-B). The results will be disseminated to the scientific audience and the general public via presentations at conferences and publication in peer-reviewed journals.

Trial registration number

NCT06047236.

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CapeOX (capecitabine and oxaliplatin) combined with sintilimab and bevacizumab biosimilar (IBI305) for first-line treatment of advanced gastric or oesophagogastric junction adenocarcinoma: study protocol for a single-arm, phase Ib/II trial

Por: Dai · R. · Zhang · P. · Cheng · M. · Bi · F. · Zhou · J. · Liu · M.
Background

A combination of chemotherapy and immune checkpoint inhibitor therapy has been demonstrated to be effective as a first-line treatment of gastric or gastro-oesophageal junction (G/GEJ) cancer. The conventional treatment strategy for patients with advanced/metastatic human epidermal growth factor receptor 2-negative G/GEJ cancer is recommended. However, the response rate and enhancements in survival are still significantly insufficient. The present study will investigate the efficacy and safety of incorporating a bevacizumab biosimilar IBI305 into chemotherapy and immunotherapy as a first-line treatment for advanced or metastatic G/GEJ cancer.

Methods and analysis

This single-arm, open-label, prospective phase Ib/II clinical study will involve 57 participants. In phase Ib of the trial, patients with advanced or metastatic G/GEJ cancer will receive capecitabine and oxaliplatin (CapeOX) together with sintilimab (200 mg intravenously every 3 weeks) and IBI305 (7.5, 10 or 15 mg/kg intravenously every 3 weeks) in a 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs) within 6 weeks of treatment initiation. In phase II, the patients will receive CapeOX combined with sintilimab and IBI305 at the recommended phase II dose. The primary objectives will be to assess DLTs (phase Ib) and the objective response rate (phase II). The secondary objectives will include progression-free survival, overall survival, disease control rate, duration of response, adverse effects, quality of life and safety.

Ethics and dissemination

The trial protocol was approved by the Ethics Committee of West China Hospital and ClinicalTrials. The final results will be published in a peer-reviewed journal upon completion of the study.

Trial registration number

NCT05640609.

Disitamab vedotin in combination with lenvatinib for patients with HER2-positive unresectable locally advanced or metastatic biliary tract cancer: study protocol of a phase II clinical trial

Por: Yang · Y. · Zhang · J. · Wu · Z. · Liu · D. · Tang · J. · Xue · J. · Wu · G.
Introduction

Chemotherapy is the standard second-line treatment option for advanced biliary tract cancer (BTC), but its therapeutic efficacy is suboptimal. Disitamab vedotin (RC48) and lenvatinib have demonstrated promising efficacy in human epidermal growth factor receptor 2 (HER2)-positive BTC and other malignancies. In this study, we aim to evaluate the efficacy and safety of RC48 in combination with lenvatinib in second-line or above treatment for HER2-positive advanced BTC.

Methods and analysis

This is a single-centre, single-arm, open-label, exploratory phase II clinical study in patients with HER2-positive unresectable locally advanced or metastatic BTC who have failed prior therapy. 31 patients will be enrolled in this study to receive the combination of RC48 and lenvatinib. The primary study endpoint is objective response rate, and the secondary study endpoints are disease control rate, duration of response, progression-free survival and overall survival.

Ethics and dissemination

The study has received approval from the Medical Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (approval No. (2023)0367-01). Results will be disseminated through publication in peer-reviewed journals and through other appropriate media channels.

Trial registration number

ChiCTR2300076406.

Hemopurifier device in patients with solid tumours who have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab: protocol for an Australian safety, feasibility and dose-finding study

Por: Brown · M. P. · Matos · M. · Clarke · S. · Coates · P. T. · Pollock · C. · Kurtkoti · J. · Grau · G. · Edinburg · K. · Bloesch · A. · de Necochea Campion · R. · Khin · N. Y. · Shin · J. · LaRosa · S. P.
Background

Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.

Methods

This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.

The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.

Ethics and dissemination

The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Trial registration number

Australia New Zealand registration number ACTRN12624000732583.

Efficacy and safety of adjuvant short-course immune checkpoint inhibitors following TACE combined with MWA in patients with BCLC A-B hepatocellular carcinoma: a single-arm, prospective, phase II study protocol

Por: Fang · Y. · Zhang · M. · Chen · J. · Han · Z. · Piao · X. · Zhang · S.
Background

Patients with early-stage to intermediate-stage hepatocellular carcinoma (HCC) face a high risk of recurrence after transarterial chemoembolisation (TACE) plus microwave ablation (MWA), often resulting in early relapse and poor prognosis. Adjuvant immunotherapy may reduce this risk by eliminating residual disease and enhancing antitumour immunity, thereby lowering recurrence and improving outcomes. However, evidence supporting adjuvant immunotherapy alone after curative locoregional therapy remains limited. This study evaluates the efficacy and safety of short-course adjuvant Tislelizumab in patients with Barcelona Clinic Liver Cancer(BCLC)stage A–B HCC treated with TACE plus MWA.

Method and analysis

This prospective, single-arm, phase II trial will enrol 30 patients with BCLC stage A–B HCC who have received TACE plus MWA. Eligibility requires complete response confirmed by modified Response Evaluation Criteria in Solid Tumors(mRECIST) on imaging 1 week after treatment. All patients will receive tislelizumab (200 mg every 3 weeks) for 6 months. Follow-up will continue until recurrence, death or study completion. The primary endpoint is investigator-assessed recurrence-free survival. Secondary endpoints include local tumour progression, intrahepatic distant recurrence, time to extrahepatic disease, overall survival and adverse events.

Ethics and dissemination

Our study was approved by the Medical Research Ethics Committee of the Yanbian University Hospital (No. 20250006). The findings of this study will be submitted for publication in peer-reviewed journals and will also be presented at multiple international conferences on interventional radiology and oncology.

Trial registration number

ChiCTR2500110080.

Investigating the symptoms and sentinel symptoms of patients with lymphoma during chemotherapy: a cross-sectional survey

Por: Gao · Y. · Wu · L. · Ji · J. · Chen · X. · Lu · J. · Cao · M.
Objectives

To investigate symptom clusters (SCs) and sentinel symptoms in patients with lymphoma during chemotherapy treatment and examine the associations between sentinel symptoms and laboratory parameters.

Design

This was a single-centre cross-sectional study.

Setting

Data collection was conducted through the General Information Questionnaire and the Chinese version of the Memorial Symptom Assessment Scale. Exploratory factor analysis was used to extract SCs, and association rule mining employing the Apriori algorithm was implemented to identify sentinel symptoms. Correlation analysis was used to explore the correlation between sentinel symptoms and laboratory indicators.

Participants

A total of 268 valid questionnaires were collected from patients.

Outcome measures

Explore SCs and sentinel symptoms in patients with lymphoma during chemotherapy and analyse the correlation between sentinel symptoms and laboratory indicators.

Results

Four distinct SCs were identified among the participants. Drowsiness, nausea, sweating and skin changes were determined as sentinel symptoms of emotional–fatigue–sleep, nutritional metabolism, lymphoma-specific and chemotherapy–body SCs, respectively. Among these symptoms, drowsiness demonstrated positive associations with white blood cell count and glutamic pyruvic transaminase levels, while exhibiting negative associations with haemoglobin, platelet and albumin levels. Sweating exhibited negative associations with platelet count. Skin changes demonstrated negative associations with D-dimer levels. There were no significant associations detected between nausea and laboratory parameters.

Conclusions

Patients receiving lymphoma chemotherapy exhibited various symptoms manifesting as four distinct SCs. The identified sentinel symptoms comprised drowsiness, nausea, sweating and skin changes. With the exception of nausea, all variables demonstrated significant associations with multiple laboratory parameters.

Trial registration number

ChiCTR2500096487.

Patient preference survey for attributes of locally advanced or metastatic urothelial carcinoma treatment in Japan: a discrete-choice experiment

Por: Kitamura · H. · Uchida · H. · Tanaka · Y. · Akiyama · T. · Morishita · A. · Yakushiji · A. · Sakurai · M.
Objective

To investigate treatment preferences of Japanese patients with locally advanced or metastatic urothelial carcinoma (la/mUC).

Design

A discrete-choice experiment survey methodology was used to elicit patient preferences for attributes of la/mUC treatment, including adverse events (nausea/vomiting, neuropathy, alopecia and maculopapular rash), hospital stay requirements for treatment administration and overall survival. A multinomial logistic regression model was used to estimate treatment preferences. Coefficients of the model were then used to calculate the relative importance of each treatment attribute.

Setting and participants

Participants were recruited through healthcare facilities with urology departments across Japan.

Results

The study included 109 patients (72.5% male; mean (SD) age, 71.3 (8.9) years). Patients preferred treatments that minimised adverse events that could affect their daily activities, had a more favourable survival profile and did not require hospital stays for administration. Neuropathy emerged as the most important attribute to patients when making treatment decisions (relative attribute importance (RAI), 27.7%), followed by nausea/vomiting (RAI, 27.3%), maculopapular rash (RAI, 16.5%), hospital stay requirements (RAI, 12.1%), alopecia (RAI, 8.2%) and overall survival (RAI, 8.1%). Findings were similar across various subgroup analyses, though patients who were chemotherapy-experienced prioritised avoidance of neuropathy and nausea/vomiting more highly than those who were chemotherapy-naïve.

Conclusions

In this study, Japanese patients with la/mUC were more concerned about reduced quality of life due to adverse events than extending survival by 6 months. Patients, clinicians and other members of the care team need to communicate frequently and candidly about a patient’s well-being.

Prognostic value of neutrophil-to-lymphocyte ratio in patients with breast cancer in Ethiopia: using inverse-probability-weighted regression adjustment

Por: Assele · D. D. · Desta · B. · Esayas · T. · Darebo · T. D. · Teklewold · B.
Objectives

This study aimed to examine the association between the neutrophil-to-lymphocyte ratio (NLR) and the prognosis of patients with breast cancer (BC) in southern Ethiopia.

Design

We conducted a hospital-based retrospective cohort study.

Setting

The study was conducted at Hawassa and Wolaita Sodo University Comprehensive Specialized Hospital.

Participants

A total of 492 women with BC diagnosed from January 2020 to December 2022 were enrolled. Follow-up extended from the date of diagnosis until the occurrence of an event (death), loss to follow-up or the study end date.

Outcome measures

Data were collected using a structured data collection tool through medical record review and exported to Stata V.16 for analysis. Unweighted and weighted Kaplan-Meier survival curves were used to estimate death-free survival time. Inverse-probability-weighted regression adjustment was employed to estimate the association of NLR with time to death. At a statistical significance level of p

Results

The incidence of mortality in patients with BC with a higher NLR was 4.2 (95% CI 3.3 to 5.2) per 100 person-month observation (PMO); it was 1.9 (95% CI 1.5 to 2.4) per 100 PMO for those with a low NLR. When everyone in the population of interest has a low NLR, the average time to death is estimated as 17.2 (95% CI 11.4 to 23.0) months. For women with a higher NLR, the average time to death is estimated as 10.8 (95% CI 8.93 to 12.8) months. For women with a higher NLR, the average time to death was shorter by 6.3 months (coefficient: –6.3, 95% CI –12.5 to –0.082). Furthermore, the effectiveness of exposure to high NLR (ratio of average treatment effect to low NLR potential outcome means) was a 36.7% (95% CI 12% to 61%) reduction in mortality rate.

Conclusions

A high NLR was associated with significantly higher mortality in BC patients, independent of baseline clinicopathological variables. Patients with elevated NLR more often presented with advanced stage disease and distant metastases. These findings indicate that NLR, a simple and accessible biomarker, may help to identify patients at increased risk of poor prognosis.

Dual checkpoint inhibitor therapy versus dual targeted therapy of untreated metastatic BRAF-mutant melanoma: a systematic review of randomised controlled trials

Por: Peinemann · F. · Baradaran · S. · Arnolds · K. B. · Hoemberg · M.
Objective

Dual immune checkpoint inhibitor (ICI) therapy might improve the outcome of adult patients with untreated metastatic BRAF-mutant melanoma. We synthesised the evidence of its effect on overall survival (OS) and adverse events.

Design

Systematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Data sources

MEDLINE and the Cochrane Library were searched through 15 May 2025.

Eligibility criteria for selecting studies

We included randomised controlled trials (RCTs) assessing the effects of first-line dual ICI therapy compared with first-line dual targeted therapy (TT) on adult patients with metastatic BRAF-mutant melanoma. We considered articles in English or German language.

Data extraction and synthesis

Two independent reviewers extracted data and assessed risk of bias. Time-to-event data were pooled using the generic inverse-variance method and expressed as HRs with 95% CIs. Dichotomous data were pooled using the Mantel-Haenszel method and expressed as risk ratios (RRs). Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic). GRADE assessed the certainty of the evidence.

Results

We identified two RCTs (305 participants) with parallel assignment and intention-to-treat analyses. The primary beneficial outcome was overall survival (OS), and OS favoured the first-line ICI group: HR 0.66 (95% CI 0.49 to 0.90) I2=0%. In contrast, the primary adverse outcome was treatment-related adverse events of grade 3 or higher (TRAEs), and TRAE favoured the first-line TT group: RR 1.18 (95% CI 1.01 to 1.39) I2=0%. The certainty of the evidence was graded as moderate.

Conclusions

The evidence base is compatible with a favourable effect of first-line nivolumab plus ipilimumab for adults with untreated metastatic BRAF-mutant melanoma on survival and an unfavourable effect on toxicity when compared with first-line TT. Future RCTs could provide more data on therapy failure and quality of life.

PROSPERO registration number

CRD420251006128.

Can we Save the rectum by watchful waiting or transanal microsurgery following shorT-course radiotherapy and Additional local oR systemic Treatment for early-stage REctal Cancer? STARTREC-3 protocol for a non-randomised, multicentre, phase II platform stu

Por: de Vries · S. E. N. · Couwenberg · A. M. · Marijnen · C. A. M. · Beets · G. L. · Burger · J. W. · Chalabi · M. · de Groot · J. W. · Intven · M. · Peulen · H. M. · Roodhart · J. M. L. · de Wilt · J. H. W. · Grotenhuis · B. A.
Introduction

Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.

Objective

The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.

Methods

STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.

Ethics and dissemination

The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.

Trial registration number

CTIS EU 2024-514620-17-00

Virtual reality-based cognitive rehabilitation programme to support employment in patients with breast cancer: protocol for the Cog-RV pilot study

Por: Vieira Jales · I. · Hummel · E. · Clarisse · B. · Gouranton · V. · Cogne · M. · Lecuyer · A. · Leconte · A. · Lequesne · J. · Ahmed-Lecheheb · D. · Morel · A. · Fernette · M. · Joly · F. · Lange · M.
Introduction

Cancer-related cognitive impairment is frequently reported by patients with breast cancer after chemotherapy. These difficulties can hinder return to work. It is therefore particularly important to assess and manage these impairments, especially to facilitate employment. We propose the Cog-VR pilot study to assess patient adherence to a virtual reality (VR)-based cognitive rehabilitation programme to support employment.

Methods and analysis

This prospective interventional pilot study aims to assess adherence to a VR-based cognitive rehabilitation programme in patients with breast cancer (n=23) treated by chemotherapy reporting cognitive complaints following cancer and its treatments. The programme consists of six weekly individual sessions (1 hour/week), including cognitive training, psychoeducation and VR immersion (10–15 min). VR tasks train executive functions, attention, memory and processing speed. The primary endpoint is the programme adherence, defined as completing at least five out of six VR sessions, each lasting a minimum of 5 min. The main secondary endpoints are objective cognitive tests and patient-reported outcomes (subjective cognitive functioning (Functional Assessment of Cancer Therapy—Cognitive Scale), anxiety/depression (Hospital Anxiety and Depression Scale) and fatigue (Functional Assessment of Chronic Illness Therapy—Fatigue)) assessed before and after the programme. Furthermore, cyber sickness (Simulator Sickness Questionnaire) at each session, VR usability (System Usability Scale—third session) and patient satisfaction to the programme will also be assessed.

Ethics and dissemination

The study was approved by the local ethics committee (French Ouest II personal protection committee no. ID RCB: 2023-A02163-42) on January 2024. It was validated by the review board of the participating center. An individual participant data-sharing statement is not planned. Written informed consent will be obtained from all patients before any study procedure. The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number

NCT06267014.

Intelligent voice-interactive tailored communication system (ScreenTalk) to improve colorectal cancer screening uptake among first-degree relatives of colorectal cancer patients: study protocol for a cluster-randomised type I hybrid effectiveness-implemen

Por: Lin · S. · Luo · B. · Cai · L. · Qiu · L. · Li · H. · Liu · W. · Luo · Y. · Yuan · Y. · Peng · Z. · Bai · Y.
Introduction

First-degree relatives of colorectal cancer (CRC) patients have a twofold to fourfold increased risk of CRC. Tailored communication interventions have shown efficacy in improving their risk awareness and screening participation. While computer-based tailoring systems offer convenience, they often overlook the integration of healthcare professionals’ verbal input, potentially limiting effectiveness and long-term impact. To address this gap, we developed ScreenTalk, an intelligent voice-interactive tailored communication system that employs intelligent speech interaction to automate the tailoring process, enhance message credibility and improve scalability within CRC screening workflows.

Methods and analysis

This study is a two-arm, cluster-randomised controlled trial with a hybrid type I design involving 314 participants across three tertiary general hospitals in Guangzhou, China. Participants in both groups will receive usual care. Additionally, the intervention group will receive a 1-month tailored intelligent voice-interactive intervention, whereas the control group will receive unrelated health education to control for attention. Screening uptake (primary outcomes) and health beliefs (secondary outcomes) are measured at baseline and at 3 months, 6 months, 9 months and 12 month post the intervention. Implementation outcomes including reach, implementation, adoption and maintenance will be assessed through questionnaire, qualitative interviews and tailored system record.

Ethics and dissemination

The trial has been approved by the Ethics Committee of the Sun Yat-sen University (IRB No. L2024SYSU-HL-054). Information on the purpose and process of this study will be provided to the participants before recruitment, and written signatures will be collected from all participants to ensure their voluntary participation and protection of their rights and privacy.

Trial registration

NCT06710860 on ClinicalTrials.gov. Registered 26 November 2024. Date and version: 3.0, 14 July 2025.

Does financial subsidy equalise cancer genetic testing uptake across socioeconomic groups? A retrospective observational study in Singapore

Por: Saxena · A. · Phay · R. · Chiang · J. · Wong · F. Y. · Yuen · J. · Ishak · D. · Tasnim · S. · Ngeow · J.
Objective

To examine the association between socioeconomic status (SES), financial subsidies and awareness-related factors such as age, cancer stage and family history, and the uptake of cancer genetic testing, with a focus on equitable access to care.

Design

Retrospective cohort study.

Setting

Tertiary care cancer genetics service in Singapore.

Participants

The study population included 2687 individuals of all ages, genders and ethnicities who attended pretest counselling between 2014 and 2020 and were eligible for genetic testing for hereditary cancer syndromes.

Primary and secondary outcome measures

The primary outcome was the uptake of genetic testing. The main explanatory variables were SES (proxied by Housing Index), subsidy status, age, cancer stage and family history. Analyses examined whether associations varied across SES and age subgroups.

Results

Receipt of financial subsidies was strongly associated with testing uptake (adjusted OR 9.15, 95% CI 2.68 to 31.20). Uptake exceeded 90% among subsidised individuals across all socioeconomic strata, compared with 56–68% among non-subsidised individuals, with the largest gains in the lowest SES group (43 vs 28 percentage points (pp) in the highest). The level of subsidy was not associated with uptake. Younger patients (18–39 years) had higher uptake than those aged 60+ (66% vs 57%); patients with advanced cancer (stage IV) had the highest uptake (82% vs 57–66% in earlier stages); and family history was associated with increased uptake, strongest for having a child with cancer (+28 pp). Interaction analysis suggested that the additive effects of subsidies were greatest in lower SES groups and in older adults.

Conclusions

Financial subsidies were strongly associated with higher genetic testing uptake. Awareness indicators like age, cancer stage and family history were associated with higher uptake. The association between subsidies and uptake varied by SES and age, suggesting that subsidies may help reduce disparities and improve equitable access to genetic testing services.

Treatment patterns, care delays and outcomes in advanced cervical cancer: study protocol for a mixed retrospective and prospective single-centre cohort in South Africa

Por: Achilonu · O. · Ayeni · O. · Adeleke · M. · Mmereki · D. · Mistry · H. · Swanson · S. · Chen · W. C. · Singini · M. · Joffe · M. · Grover · S. · RAMIAH · D.
Introduction

Cervical cancer (CaCx) is a leading cause of cancer-related deaths among women in South Africa, often presenting at advanced stages and requiring chemoradiotherapy. In South Africa, the burden is disproportionately high among women living with HIV, with limited access to radiotherapy further compounding treatment challenges. Despite this documented disparity, limited data exist on patients in a South African context. This protocol describes the research methodology to assess patterns of care, treatment delays, interruptions and survival outcomes in patients with advanced CaCx, addressing an urgent need for local data in low-income and middle-income countries to provide evidence-based improvements in care.

Methods and analysis

The Cervical Cancer Cohort at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH-CCC), initiated in 2023, is a mixed retrospective and prospective single-centre study investigating the characteristics, challenges and outcomes of patients with advanced CaCx. It includes women aged ≥18 years with a histopathological diagnosis of stage IB3–IVA CaCx treated at CMJAH Radiation Oncology. The retrospective component covers data from September 2018 to August 2023. Data collection is complete and the team is currently conducting quality control. The prospective component began in October 2023 and aims to enrol participants over 2 years, with follow-up for up to 3 years. The study is ongoing, and an extension for continued enrolment beyond September 2025 is being sought. Participants provide baseline data on demographics, socioeconomic status, cultural influences and healthcare access, with updates every 3 months. When necessary, the next of kin provides follow-up information. The study aims to inform strategies to improve outcomes and reduce the CaCx burden in South Africa.

Ethics and dissemination

Ethics approval for this study was obtained from the Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg, South Africa, with an ethical clearance certificate (MM221001 MED22-09-085). The results will be widely distributed through presentations at national and international conferences and published in peer-reviewed open-access journals, ensuring wide access to the results.

Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy--Px7 The study protocol of a multicentre binational randomised controlled trial

Por: Agache · A. · Deding · U. · Kaalby · L. · Kobaek-Larsen · M. · Al-Najami · I. · Ostergaard Hansen · L. · Stryhn · C. · Wilde · D. · Forsberg · A. · Backman · A.-S. · Bates · T. · de Lange · T. · Martling · A. · Baatrup · G.
Introduction

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

Methods and analysis

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Ethics and dissemination

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

Trial registration number

NCT06335420.

Understanding preferences for self-sampling in a national cervical screening programme: a protocol for a discrete choice experiment

Por: Thapa · S. · Davies · J. C. · Crosbie · E. J. · Payne · K. · Wright · S.
Introduction

The National Health Service Cervical Screening Programme (NHSCSP) currently involves a healthcare professional collecting a cervical sample in a healthcare setting. This method of screening has barriers associated with access to screening appointments and the poor acceptability of the speculum examination. Primary screening through HPV testing has led to the development of self-sampling screening methods including vaginal and urine self-sampling, with many UK studies comparing these screening methods with the current NHSCSP. It is not known what features of self-sampling influence individuals’ preferences and cervical screening uptake. To understand these preferences, we plan to undertake a discrete choice experiment (DCE). This protocol aims to describe the steps taken to design the DCE and the proposed approach to fielding the DCE to identify preferences for different sampling approaches in cervical screening.

Methods and analysis

An online survey comprising a DCE was designed to understand preferences of individuals for self-sampling methods within the NHSCSP. Attributes and levels for the DCE were generated through an iterative process including a literature review of qualitative studies about self-sampling cervical screening methods, input from cervical screening clinical experts and a patient and public involvement group (n=6). A D-efficient design was used to create choice sets for the DCE survey. Regression-based analysis will be used to estimate the impact of each attribute and level on individual choices.

Ethics and dissemination

This study has been approved by The University of Manchester Proportionate Research Ethics Committee (2024-20767-37669). The results of the DCE will be submitted for publication in a relevant peer review journal and the results will be presented at national and international conferences.

Data statement

There are no data associated with this protocol. The data produced by this study and analysis scripts will be made available in a public repository following publication of the study.

Stiefel MD Anderson OroPharynx cancer (MDA-OPC) cohort: a single-institution, prospective longitudinal outcomes study

Por: Moreno · A. · Sahli · A. J. · Johnson · F. · Sun · X. · Barbon · C. · Rinsurongkawong · W. · Song · W. · Luciani · F. M. · Liang · H. · Li · J. · Liu · W. · Lee · J. J. · Frank · S. · Lai · S. · Fuller · C. · Hutcheson · K. · P01 MD Anderson Oropharynx Cancer Program · Hutcheson · Lai · F
Purpose

The MD Anderson Oropharynx Cancer (MDA-OPC) cohort is a unique single-institution, prospective longitudinal cancer cohort. The cohort aims to enhance the therapeutic index of OPC management by supporting data needs for independent investigators to conduct rigorous observational studies examining exposures and factors associated with acute and late toxicities, cancer progression, recurrence, new malignancies and quality of life in OPC survivors.

Participants

A total of 1811 patients with OPC with a minimum follow-up of 6 months have been consented to our prospective registry between 18 March 2015 and 29 December 2023. Clinical and treatment (Tx) data are available on all patients, including previously untreated patients (1443, 80%). Most previously untreated patients (97%) consented to longitudinal patient-reported outcomes and functional assessments for critical time points including pre-Tx, during-Tx and post-Tx at 3–6 months, 12 months, 18–24 months and annually up to 5 years.

Findings to date

The median age for the MDA-OPC cohort is 66 years (range, 25–96) with the majority being male (89%), white (92%) and with human papillomavirus (HPV)/p16-associated OPC (88%) primarily located in the tongue base or tonsil (90%). For previously untreated patients, 79% were diagnosed with stage I/II disease, and nearly half underwent curative intent chemoradiation. Overall survival was significantly higher for HPV/p16-associated OPC at 1 year (98% vs 93%) and 5 years (83% vs 54%; p

Future plans

Future work includes expansion of the MDA-OPC cohort and survivorship surveillance to 10 years under the recently funded OPC-SURVIVOR research programme (P01CA285249), which aims to identify non-invasive, clinic-ready biomarkers and examine novel phenotypes and mechanistically matched mitigation strategies for latent OPC sequelae. Additionally, we aim to expand our advanced data infrastructure by integrating large data streams from parallel clinical trials and imaging registries.

Trial registration numbers

NCT01893307, NCT03145077.

'I think it depends how its done: a qualitative study of screening attendees perspectives on receiving physical activity advice within UK NHS cancer screening programmes

Por: Murphy · J. · Stevens · C. · Roberts · A. L. · Vrinten · C. · Waller · J. · Smith · S. G. · Beeken · R. J.
Objectives

Cancer screening appointments are an opportunity to encourage positive behavioural changes. Up to 80% of cancer screening attendees are open to discussing physical activity during cancer screening, but some say this would deter them from future screening. This study aimed to gain an in-depth understanding of individuals’ receptivity to physical activity advice at cancer screening.

Design

Interview-based qualitative study.

Setting and participants

The study was conducted from May 2017 to September 2018 in the UK. Participants were recruited using adverts on two university campuses, Facebook and a participant recruitment agency. To be eligible, participants had to have an upcoming cancer screening appointment within 2 weeks. There were 30 participants.

Procedures

Participants recorded their receptivity to physical activity advice in the days before and after screening. Data-prompted semi-structured interviews explored these responses. Interviews were analysed using a thematic framework analysis.

Results

Participants felt discussing physical activity at cancer screening would be relevant. However, participants experienced anxiety related to the screening process which could increase or decrease their receptivity. Participants felt if information was delivered in a judgemental way, it could negatively impact future screening participation.

Conclusions

Screening attendees’ receptivity could be influenced by the timing of a discussion and by their levels of anxiety throughout screening. Participants’ anxiety during screening can either reduce their ability to engage in a discussion or increase the relevance of the discussion. The communication style of the healthcare practitioner was key for why some screening attendees could be deterred from future cancer screening.

Adherence to Choosing Wisely Africa recommendations in breast cancer care: a cross-sectional study across three Sub-Saharan African centres

Por: Rubagumya · F. · Rugengamanzi · E. · Nyagabona · S. K. · Ndumbalo · J. · Kwizera · V. · Uwimbabazi · A. · Celyna · K. · Ayettey · H. · Vanderpuye · V. · Hopman · W. M. · Hammad · N. · Booth · C. M.
Objective

The expenses associated with cancer treatment are increasing at a rapid pace. The financial strain of providing care is experienced worldwide, but is particularly pronounced in low and middle-income countries (LMICs). This has resulted in a growing acknowledgement of the importance of value-based cancer care. Choosing Wisely Africa (CWA) is an initiative aimed at reducing the excessive use and expenses associated with cancer treatment. In this study, we assessed adherence to CWA recommendations for the treatment of breast cancer in three high-volume cancer centres in Sub-Saharan Africa (SSA).

Design

A cross-sectional study across Rwanda, Ghana and Tanzania was conducted, involving a review of medical records to assess adherence to five measurable CWA practices in breast cancer care. The study used inferential statistics, such as 2 tests, to compare adherence among these countries.

Settings

This study was conducted in three cancer centres (Ocean Road Cancer Institute, Rwanda Military Hospital and Korle Bu Teaching Hospital) in three countries (Tanzania, Rwanda and Ghana, respectively).

Participants

A total of 542 patients were recruited. Eligible patients were those with a breast cancer diagnosis and complete data as pertaining to five CWA recommendations.

Results

A total of 542 participants with a mean age of 51 years were included. Participants were well distributed across Ghana (37%), Rwanda (34%) and Tanzania (29%). Female patients represented 97% of the study cohort. Half (51%) of the participants had some form of insurance. The study observed high adherence to cancer staging (94%) before treatment and histological confirmation (91%) before breast lump removal across all sites. Hypofractionation was used in 0% of cases in Rwanda, 42% in Ghana and 70% in Tanzania.

Conclusion

This study provides critical insights into the implementation of CWA recommendations in breast cancer care in SSA. It highlights the disparities in adherence to CWA recommendations across different centres, showing the need for policy-driven changes and healthcare infrastructure improvement to standardise cancer care practices in LMICs.

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