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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.

Scoping review protocol of person- and patient-centred outcomes in cancer clinical trials: definitions and methodologies

Por: Zambrano Lucio · M. · Bhoo-Pathy · N. · Menon · S. · Huang · Z. · Unger-Saldana · K.
Introduction

Traditional oncology outcome measures, such as survival rates and disease progression, fail to fully capture the complex lived experiences of persons and patients with cancer, including psychological distress, financial burdens and changes in social roles. While person- and patient-centred outcomes have emerged as essential components of quality cancer care, ambiguities persist regarding their definitions and measurement methodologies in clinical trials.

Methods and analysis

This scoping review aims to explore how person-centred and patient-centred outcomes are defined and measured in cancer clinical trials and to identify trends, gaps and methodological approaches for their assessment. Comprehensive searches will be conducted across PubMed, SCOPUS, Sci-Elo, EMBASE, PsycINFO and Google Scholar for grey literature sources, encompassing articles from August 2020 to August 2025. Eligible studies include primary research that reports patient- or person-centred outcomes in cancer clinical trials. Studies focusing solely on preventative care or lacking assessment of patient- or person-centred outcomes will be excluded. Studies will be independently screened and selected by two reviewers in duplicate, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Data extraction will also be conducted independently and in duplicate using a standardised extraction tool, with disagreements resolved through consensus to ensure consistency and accuracy. Results will be synthesised qualitatively and quantitatively, with narrative and thematic analysis used to identify trends and gaps in the literature.

Ethics and dissemination

Ethical approval is not required. Results will be published in a peer-reviewed journal and presented at conferences.

Trial registration number

https://doi.org/10.17605/OSF.IO/EYZPK

Prognostic value of RANK signalling in breast cancer: a systematic review and meta-analysis

Por: Li · L. · Wang · X. · Li · Y. · Shen · S. · Xu · Y. · Zhou · Y. · Sun · Q.
Objectives

To evaluate the prognostic value of osteoprotegerin (OPG), receptor activator of nuclear factor-B (RANK) and RANK ligand (RANKL) of the RANK signalling in patients with breast cancer.

Design

Systematic review and meta-analysis.

Data sources

We searched the PubMed, Embase and Cochrane databases up to October 2024.

Eligibility criteria

Studies of patients with primary breast cancer evaluating OPG, RANK or RANKL expression in relation to survival outcomes were included.

Data extraction and synthesis

Data from eligible studies were extracted, and HRs with 95% CIs for overall survival (OS), metastasis-free survival (MFS) and disease-free survival (DFS) were used to assess prognostic value.

Results

A total of 18 studies, comprising 11 141 patients with primary breast cancer, were included in this analysis. Elevated OPG expression was found to be significantly associated with an increase in MFS (HR=0.59, 95% CI 0.44 to 0.80, p

Conclusions

Downregulation of the RANK signalling predicts survival benefits in patients with primary breast cancer. Further investigation is warranted to explore the therapeutic potential of inhibiting RANK signalling in breast cancer.

PROSPERO registration number

CRD42021234825.

Personalising anal cancer radiotherapy dose (PLATO): protocol for a multicentre integrated platform trial

Por: Frood · R. · Gilbert · A. · Gilbert · D. · Abbott · N. L. · Richman · S. D. · Goh · V. · Rao · S. · Webster · J. · Smith · A. · Copeland · J. · Ruddock · S. P. · Berkman · L. · Muirhead · R. · Renehan · A. G. · Harrison · M. · Adams · R. · Hawkins · M. · Brown · S. · Sebag-Montefiore · D.
Introduction

The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.

PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.

Methods and analysis

The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.

Ethics and dissemination

This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.

Trial registration number

ISRCTN88455282.

Views of European Union medicine regulators and healthcare professionals on the approved versus prescribed dose of protein kinase inhibitors: an interview study

Por: Brinkhof · M. · de Vries · S. T. · Mol · P. G. M. · Trapani · D. · Marije de Jong · I. · Broekman · K. E.
Objective

To explore perceptions regarding the approved and actual prescribed doses of protein kinase inhibitors (PKIs) in clinical practice in the European Union among medicine regulators and healthcare professionals (HCPs).

Design

A qualitative descriptive study was conducted using semistructured interviews, continuing until thematic saturation was reached. Thematic analysis was undertaken using a combined deductive-inductive approach. Deductive main analytical themes were derived from the theoretical framework of questioning-based policy design, namely problem sensing, problem categorisation and problem decomposition. Subthemes were generated inductively and could coherently be situated within these main analytical themes.

Setting

Interviews were held online or in person at a location convenient for the interviewee, depending on the participant’s preference.

Participants

Seven medicine regulators involved in the regulation of cancer medicines—including PKIs—and 10 HCPs prescribing PKIs in clinical practice, from various countries within Europe, were included.

Results

Regulators highlighted insufficient attention to optimal dose finding, yielding approved doses often based on outdated maximum tolerated dose concepts, leading to uncertainties in efficacy and safety. HCPs reported using alternative dosing strategies in clinical practice to improve tolerability and quality of life (QoL) but noted a lack of robust evidence to guide such adjustments and faced legal constraints to deviate from the approved dose. Participants emphasised the need for improved pre-approval and post-approval dose optimisation to improve safety, enhance QoL and bridge gaps between trial data and real-world patient diversity.

Conclusions

Collaborative efforts involving multistakeholders including HCPs, regulators, pharmaceutical companies, insurers, governments and patient representatives are essential to advance dose optimisation and improve patient-centric outcomes, with further research needed to understand these stakeholders’ perspectives.

NEOadjuvant Dendritic cell therapy added to first line standard of care in advanced epithelial Ovarian Cancer (NEODOC): protocol of a first-in-human, exploratory, single-centre phase I/II trial in the Netherlands

Por: Koeneman · B. · Schreibelt · G. · Duiveman - de Boer · T. · Bos · K. · van Oorschot · T. · Pots · J. · Scharenborg · N. · de Boer · A. · Hins - de Bree · S. · de Haas · N. · de Goede · A. · Westdorp · H. · van Ham · M. · de Vries · I. J. M. · Ottevanger · P. B.
Introduction

The currently available immunotherapies have failed to meet expectations in inducing durable responses in patients with advanced epithelial ovarian cancer (EOC). The low number of somatic missense mutations in EOC necessitates highly potent neoantigen-directed approaches. To this end, we have developed a novel dendritic cell (DC) product that consists of a specialised cross-presenting subset of DC, conventional DC type 1 (cDC1).

Methods and analysis

We will conduct the NEODOC study, an investigator-initiated first-in-human phase I/II trial. This study will assess the immunogenicity, safety and feasibility of a cDC1-based, autologous tumour lysate-loaded, DC product. 10 patients with previously untreated advanced EOC (stage IIIb-c, IVa or stage IVb if only supradiaphragmatic or inguinal lymph nodes

Ethics and dissemination

Ethical approval for this trial was granted by the Netherlands Central Committee on Research Involving Human Subjects. The results will be disseminated through publications in international, open-access scientific journals and presentations at scientific conferences.

Trial registration number

NCT05773859; EUCT number 2024-512353-24-01.

Tirzepatide for fertility-sparing treatment in obese/overweight patients with endometrial cancer and atypical hyperplasia: a phase II single-arm clinical trial protocol

Por: Zheng · J. · Yang · J. · Yang · J.
Introduction

Approximately 3–5% of patients with endometrial cancer (EC) are diagnosed under the age of 40 years, with 70% of these individuals being nulliparous. Consequently, fertility-sparing treatment for eligible young patients with endometrial lesions is increasingly being accepted. Obesity is a well-known factor closely associated with the incidence and prognosis of endometrial lesions. As obesity rates rise, weight loss interventions become particularly important in the treatment of these patients. Tirzepatide is currently the most effective glucagon-like peptide-1 receptor agonist for weight control. This trial aims to explore the synergistic effects and safety of tirzepatide combined with standard fertility-preserving treatment for endometrial lesions.

Methods and analysis

This single-arm, phase II clinical trial aims to evaluate the efficacy and safety profile of tirzepatide as an adjunctive therapy to standard fertility-sparing treatment in obese or overweight patients with atypical hyperplasia (AH) or EC. The study will enrol a total of 45 patients, each receiving a combination of standard fertility-sparing treatment for EC and AH alongside tirzepatide. The primary outcomes include the reversal rate and time to remission (in months) of endometrial lesions, which are determined through endometrial pathology sampling every 3 months, as well as the percentage of weight reduction. Secondary objectives include evaluating changes in body morphology and composition, alterations in metabolic parameters during the study, as well as reproductive outcomes and the rate of tumour recurrence during follow-up.

Ethics and dissemination

This study has received approval from the Ethics Committee of Peking Union Medical College Hospital (I-25PJ1055). Written informed consent will be obtained from all participants. The trial results will be disseminated through peer-reviewed medical journals and presented at an academic conference.

Trial registration number

ChiCTR2500102009.

Benefit and prognosis prediction of radiation therapy in colorectal cancer liver metastases: a retrospective, population-based, propensity score-matched study

Por: Wei · T. · Pan · Z. · Feng · X. · Long · Y.
Background

The benefits and optimal sequencing of radiation therapy (RT) for colorectal cancer liver metastases (CRLM) remain unclear. Therefore, using a large population-based dataset, this retrospective study aimed to evaluate the impact of RT on overall survival (OS) and determine its optimal timing. Furthermore, a nomogram was developed to predict OS in CRLM patients receiving RT.

Methods

This population-based retrospective cohort study used data from the Surveillance, Epidemiology and End Results database, including 5141 patients diagnosed with CRLM between 2010 and 2019. OS rates were conducted using Kaplan-Meier curves and log-rank tests. Propensity score matching (PSM) was employed to reduce baseline confounding between the RT and non-RT groups. Univariate and multivariate Cox regression analyses were performed to identify independent prognostic factors for OS in CRLM patients receiving RT. A nomogram for predicting OS was constructed using R software.

Results

After PSM, 536 patients were included in both the RT and non-RT groups. The mean OS time was 26 months in the RT group and 22 months in the non-RT group, with a statistically significant difference confirmed by the log-rank test (p

Conclusions

RT, particularly when administered in a combined preoperative and postoperative approach, is associated with long-term survival benefits in CRLM patients. The constructed nomogram, while demonstrating moderate predictive accuracy, serves as an initial tool for individualised OS estimation. These hypothesis-generating findings highlight the potential value of RT and warrant further validation through larger, prospective studies to develop more robust predictive models for personalised treatment strategies.

Lived experiences of chemotherapy-induced oral mucositis among patients with breast cancer: a phenomenological study

Por: Ababneh · A. · Alrida · N. A. · Ababneh · A. · Eid · H. M. · Tailakh · S. · Al-Zubi · B.
Objective

This study aimed to describe the experiences of chemotherapy-induced oral mucositis among patients with breast cancer. Its primary focus is on how chemotherapy-induced oral mucositis affects day-to-day functioning, psychological wellness and overall quality of life.

Methods

12 Jordanian women who had been diagnosed with breast cancer and had presented with chemotherapy-induced oral mucositis were the purposive sample for this qualitative study, which employed in-depth, semistructured interviews. The verbatim transcriptions of the interviews were subjected to thematic analysis.

Results

The thematic analysis of the 12 participants’ reviews revealed five main themes: distressing physical manifestations, eating and nutritional struggles, mouth care difficulties, psychological strain, social and emotional consequences, and coping and adaptation strategies.

Conclusions

Breast cancer patients’ daily routines, mental health and quality of life are all significantly impacted by chemotherapy-induced oral mucositis. According to the study, individuals with breast cancer who experience chemotherapy-induced oral mucositis should get patient-centred care and address their emotional, psychological, social and physical discomfort to maximise their outcomes.

Measuring health-related quality of life of patients with metastatic colorectal cancer using the Jordanian EQ-5D-3L value set: a cross-sectional observational study

Por: Al Habash · K. · Turfa · R. · Jaddoua · S. · Al Rabayah · A.
Objective

Health-related quality of life (HRQoL) of metastatic colorectal cancer (mCRC) in Jordan has been previously evaluated using disease-specific HRQoL tools. Meanwhile, data on HRQoL utility scores for calculating Quality-Adjusted Life Years for economic evaluations are lacking. In this study, we aim to describe, measure and identify predictors of HRQoL utility scores in patients with mCRC.

Design

This was a cross-sectional, non-interventional, observational study.

Setting

A specialised cancer centre in Jordan.

Participants

A cross-sectional questionnaire survey was conducted on 164 mCRC adult patients.

Outcome measures

Using the five-level EuroQol-3-dimension (EQ-5D-3L) instrument, patients’ health profiles were described and then valued using the EQ-5D-3L value set for Jordan to generate a single utility score. The Kruskal-Wallis test assessed differences in mean utility scores across patient characteristic categories. A Tobit regression model was used to identify potential predictors of HRQoL in mCRC patients.

Results

A total of 164 patients were enrolled with a mean age of 59 years, a mean utility score of 0.78 (SD±0.25) and visual analogue scale score of 68.78 (SD: ±19.9). 19% of patients had a stoma, and most of the patients reported health problems (72%); pain and discomfort were reported by (55%), followed by mobility (32%), usual activities (29%), anxiety/depression and self-care (13%). Analysis revealed that patients with more than one metastatic site, those who received more than one line of systemic treatment, were currently on chemotherapy, received systemic therapy in the last year or had peritoneal metastasis were found to have significantly lower utility scores (p

Conclusion

Utility scores measured in this study could be valuable for future economic evaluations of mCRC treatments. Pain and discomfort were the most reported problems among patients, highlighting the need for further evaluation to improve pain management strategies. Additionally, our regression analysis identified significant predictors of HRQoL.

Oesophageal cancer and its associated factors among patients attending surgical and oncology clinics at Garissa County Referral Hospital, Kenya: a case-control study

Por: Bashir · A. · Ngari · M. · Otieno · B. · YDhidha-a-Mjidho · M. · Abdullahi · O. · Kariuki · S. M.
Background

Oesophageal cancer (EC) is a common cause of cancer mortality. Evidence on the burden, risk factors and treatment outcomes is limited in low-income and middle-income countries. This study aimed to describe the features of EC cases and determine associated factors among patients attending surgical and oncology clinics in Garissa County Referral Hospital (GCRH).

Methods

We conducted a case–control study in which cases were patients with EC and positive histological confirmation and controls were patients admitted to GCRH for other diseases. Data on exposures were extracted from patient files. Data on tobacco and alcohol use were based on current or past use as documented in the records; hot tea intake referred to habitual consumption. Mixed-effect logistic regression model was used to determine EC-associated factors.

Results

141 cases and 282 controls were recruited. Of the 141 cases, 59 (42%) had cancer in the lower third of the oesophagus, whereas 72 (51%) and 10 (7%) had cancers in the middle and upper thirds, respectively. EC was associated with tobacco use (adjusted OR (AOR), 21.02, 95% CI 5.41 to 81.69), consumption of hot tea (AOR 59.87, 95% CI 5.45 to 657.35), chewing khat (miraa, AOR 9.94, 95% CI 3.59 to 27.52), gastro-oesophageal reflux disease (GERD) (AOR 54.12, 95% CI 24.48 to 119.62), gastritis (AOR 17.89, 95% CI 2.94 to 108.989) and peptic ulcer disease (PUD) (AOR 69.31, 95% CI 14.09 to 340.9). Among the case group, 95 (65%) had surgery or gastrostomy tube placement as treatments for EC.

Conclusion

The study findings highlight modifiable risk factors for EC, including tobacco use, hot tea consumption, chewing miraa, GERD, gastritis and PUD. Targeted screening of high-risk patients may improve early detection and outcomes.

Mediating roles of social connection and stress-coping self-efficacy in the association between physical activity and emotional distress among lung cancer survivors: a cross-sectional study

Por: Yang · J. · Bao · R. · Chen · Z. · Han · C. · Zhao · Y. · Niu · X. · Dong · D. · He · Y. · Chu · Q.
Objectives

Although previous studies have examined the psychological benefits of physical activity in cancer survivors, the underlying psychological mechanisms among lung cancer survivors remain poorly understood. This study aims to examine the parallel mediating roles of social connection and self-efficacy in stress coping in the association between physical activity and psychological distress (anxiety and depression) among Chinese lung cancer survivors.

Design

A cross-sectional observational study.

Setting

A tertiary care hospital in Shanghai, China.

Participants

A total of 588 lung cancer survivors were recruited and assessed physical activity, anxiety, depression, social connection and self-efficacy in stress coping. Path analysis was conducted to examine the parallel mediating effects of social connection and self-efficacy in stress coping in the association between physical activity and psychological distress (anxiety and depression).

Outcome measures

The primary outcome was the examination of the mediating effects of social connection and self-efficacy in stress coping on the relationship between physical activity and psychological distress, assessed using path analysis.

Results

Social connection (p=0.003 for anxiety; p

Conclusion

These findings suggest that social connection and self-efficacy in stress coping may serve as critical psychological mechanisms underlying the association between physical activity and emotional well-being among Chinese lung cancer survivors. Interventions targeting anxiety and depression in lung cancer survivors may benefit from integrating strategies to enhance physical activity while promoting social connection and self-efficacy in coping to optimise psychological outcomes.

Multicancer early detection in a cohort of patients with confirmed and suspected cancer by measuring plasma amino acid cross sections with the Enlighten test: MODERNISED protocol

Por: Wilding · S. · Goss · V. · Sukdao · W. · Hamady · Z. · Lord · J. · Coleman · A. · Pointer · C. · Walters · J. · Herbert · W. · Mclaughlin · K. · Waugh · R. · Irvine · N. · Oliver · T. · Soulsby · I. · Hooper · J. · Crabb · S. J. · Griffiths · G. · Yates · E. · Davies · A.
Introduction

Detecting cancer earlier improves treatment options and long-term survival. A multicancer early detection test that reliably picks up early-stage cancer would potentially save lives and reduce the cost of treating cancer. One promising candidate is the Enlighten test, which applies machine learning to plasma amino acid concentrations to detect cancer. In a cohort of 77 patients recently diagnosed with breast, colorectal, pancreatic or prostate cancer, 60 (78%) were detected by the test (sensitivity), with no false positives in 20 healthy controls. The MODERNISED study will further develop the Enlighten test to detect 10 different cancers by adding bladder, lung, melanoma, oesophageal, ovarian and renal cancer to the test.

Methods and analysis

MODERNISED (ISRCTN17299125) is a multicentre prospective, non-interventional, case–control study. We aim to recruit 1000 adult participants with a recent cancer diagnosis, 250 adult participants with symptoms of cancer where a cancer diagnosis was ruled out by the National Health Service (NHS) standard of care and 100 healthy adult volunteers. Cancer tissue of origin (ToO) will include bladder, breast, colorectal, lung, melanoma, oesophageal, ovarian, pancreatic, prostate and renal. Participants in the two non-cancer cohorts who are later diagnosed with cancer will be moved to the cancer cases cohort. The primary aim is to train and validate a machine learning algorithm to detect cancer, which will be evaluated by AUROC. Secondary aims include training and validating an algorithm to predict ToO and stage of cancer, exploring differences in performance by demographics and estimating how sensitivity varies across specificity cut-offs of 95%, 99% and 99.9%. These results will provide a statistically powered estimate of how well the Enlighten test can discriminate between individuals with and without cancer, which can then be validated for clinical use in further research.

Ethics and dissemination

This study is sponsored by University Hospital Southampton NHS Foundation Trust and has been approved by the Health Research Authority and Health and Care Research West Midlands (24/WM/0234). Results will be presented at scientific meetings and published in international peer-reviewed journals. Lay summaries of study progress and findings will be published on the Southampton Clinical Trial Unit’s website.

Trial registration number

ISRCTN17299125.

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