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☐ ☆ ✇ BMJ Open

Real-world data evaluating Guys rapid diagnostic clinic as an alternate pathway for patients with FIT levels below 10

Por: Monroy-Iglesias · M. J. · Martin · S. · Cargaleiro · C. · Jones · G. · Steward · L. · Murtagh · C. · Bruno · F. · Millwaters · J. · Schizas · A. · Watson · H. · Haire · A. · Haire · K. · Moss · C. L. · Russell · B. · Srirajaskanthan · R. · Van Hemelrijck · M. · Dolly · S. — Abril 16th 2024 at 08:27
Objective

To analyse the effectiveness of rapid diagnostic clinics (RDCs) as an alternative pathway for patients with concerning symptoms and a faecal immunochemical test (FIT) result

Design

A retrospective and prospective cohort study.

Setting

GSTT RDC, one of England’s largest single-centre RDCs. Sociodemographic and clinical characteristics of FIT

Participants

Patients with an FIT result

Results

A total of 1299 patients with an FIT

Conclusion

This study demonstrates the effectiveness of RDCs as an alternate pathway for FIT

☐ ☆ ✇ BMJ Open

Developing quality indicators for cancer hospitals in China: a national modified Delphi process

Por: Liu · M. · YU · Q. · Liu · Y. — Abril 10th 2024 at 03:18
Objective

Although demand and supply of cancer care have been rapidly increasing in recent decades, there is a lack of systemic quality measurement for cancer hospitals in China. This study aimed to develop a set of core indicators for measuring quality of care for cancer hospitals in China.

Design

The development of quality indicators was based on a literature review and a two-round modified Delphi survey. The theoretical framework and initial indicators were identified through the comprehensive literature review, and the selection of quality indicators relied on experts’ consensus on the importance and feasibility of indicators by the modified Delphi process. In addition, indicator weight was identified using the analytical hierarchical process method and percentage weight method.

Setting and participants

A panel of leading experts including oncologists, cancer care nurses, quality management experts from various regions of China were invited to participate in the two-round modified Delphi process from October to December 2020. A total of 25 experts completed the two-round modified Delphi process.

Results

The experts reached consensus on a set of 47 indicators, comprising 17 structure indicators, 19 process indicators and 11 outcome indicators. Experts gave much higher weight to outcome indicators (accounting for 53.96% relative weight) than to structure (16.34%) and process (29.70%) indicators. In addition, experts also showed concerns and gave suggestions on data availability of specific outcome indicators.

Conclusions

Drawing on the comprehensive literature review and the modified Delphi process, this study developed a core set of quality indicators that can be used to evaluate quality performance of cancer hospitals. This is helpful in supporting quality cancer care in China and will provide new insights into the systemic measurement of cancer care internationally.

☐ ☆ ✇ BMJ Open

Role of patient characteristics in adherence to first-line treatment guidelines in breast, lung and prostate cancer: insights from the Nordic healthcare system

Por: Sandström · N. · Leppälä · E. · Jekunen · A. · Johansson · M. · Andersen · H. — Abril 9th 2024 at 02:08
Objectives

This study investigates the influence of socioeconomic status, health literacy, and numeracy on treatment decisions and the occurrence of adverse events in patients with breast, lung, and prostate cancer within a Nordic healthcare setting.

Design

A follow-up to a cross-sectional, mixed-methods, single-centre study.

Setting

A Nordic, tertiary cancer clinic.

Participants

A total of 244 participants with breast, lung and prostate cancer were initially identified, of which 138 first-line treatment participants were eligible for this study. First-line treatment participants (n=138) surpassed the expected cases (n=108).

Interventions

Not applicable as this was an observational study.

Primary and secondary outcome measures

The study’s primary endpoint was the rate of guideline adherence. The secondary endpoint involved assessing treatment toxicity in the form of adverse events.

Results

Guideline-adherent treatment was observed in 114 (82.6%) cases. First-line treatment selection appeared uninfluenced by participants’ education, occupation, income or self-reported health literacy. A minority (3.6%) experienced difficulties following treatment instructions, primarily with oral cancer medications.

Conclusions

The findings indicated lesser cancer health disparities regarding guideline adherence and treatment toxicity within the Nordic healthcare framework. A causal connection may not be established; however, the findings contribute to discourse on equitable cancer health provision.

☐ ☆ ✇ BMJ Open

Qualitative study exploring the design of a patient-reported symptom-based risk stratification system for suspected head and neck cancer referrals: protocol for work packages 1 and 2 within the EVEREST-HN programme

Por: Albutt · A. · Hardman · J. · McVey · L. · Odo · C. · Paleri · V. · Patterson · J. · Webb · S. · Rousseau · N. · Kellar · I. · Randell · R. — Abril 6th 2024 at 03:44
Introduction

Between 2009/2010 and 2019/2020, England witnessed an increase in suspected head and neck cancer (sHNC) referrals from 140 to 404 patients per 100 000 population. 1 in 10 patients are not seen within the 2-week target, contributing to patient anxiety. We will develop a pathway for sHNC referrals, based on the Head and Neck Cancer Risk Calculator. The evolution of a patient-reported symptom-based risk stratification system to redesign the sHNC referral pathway (EVEREST-HN) Programme comprises six work packages (WPs). This protocol describes WP1 and WP2. WP1 will obtain an understanding of language to optimise the SYmptom iNput Clinical (SYNC) system patient-reported symptom questionnaire for sHNC referrals and outline requirements for the SYNC system. WP2 will codesign key elements of the SYNC system, including the SYNC Questionnaire, and accompanying behaviour change materials.

Methods and analysis

WP1 will be conducted at three acute National Health Service (NHS) trusts with variation in service delivery models and ensuring a broad mixture of social, economic and cultural backgrounds of participants. Up to 150 patients with sHNC (n=50 per site) and 15 clinicians (n=5 per site) will be recruited. WP1 will use qualitative methods including interviews, observation and recordings of consultations. Rapid qualitative analysis and inductive thematic analysis will be used to analyse the data. WP2 will recruit lay patient representatives to participate in online focus groups (n=8 per focus group), think-aloud technique and experience-based codesign and will be analysed using qualitative and quantitative approaches.

Ethics and dissemination

The committee for clinical research at The Royal Marsden, a research ethics committee and the Health Research Authority approved this protocol. All participants will give informed consent. Ethical issues of working with patients on an urgent cancer diagnostic pathway have been considered. Findings will be disseminated via journal publications, conference presentations and public engagement activities.

☐ ☆ ✇ BMJ Open

Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe

Por: Zhang · J. · Kelkar · S. S. · Prabhu · V. S. · Qiao · Y. · Grall · V. · Miles · N. · Marth · C. — Abril 3rd 2024 at 04:16
Objective

To evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe.

Design

Endometrial Cancer Health Outcomes-Europe (ECHO-EU) is a retrospective patient chart review study.

Setting

ECHO-EU is a multicentre study conducted in the UK, Germany, Italy, France and Spain.

Participants

Patients with recurrent/advanced endometrial cancer who progressed between 1 July 2016 and 30 June 2019 following prior first-line systemic therapy were eligible and data were collected until last available follow-up through November 2021.

Primary and secondary outcome measures

Data collected included patient demographics, clinical and treatment characteristics, and clinical outcomes. Kaplan-Meier analyses were performed since initiation of second-line therapy to estimate time to treatment discontinuation, real-world progression-free survival (rwPFS) and overall survival (OS).

Results

A total of 475 patients were included from EU5 countries. Median age was 69 years at advanced endometrial cancer diagnosis, 78.7% had stage IIIB–IV disease, 45.9% had Eastern Cooperative Oncology Group status ≥2 at second-line therapy initiation. In second line, a majority of patients initiated either non-platinum-based chemotherapy (55.6%) or endocrine therapy (16.2%). Physician-reported real-world overall response rate (classified as complete or partial response) to second-line therapy was 34.5%, median rwPFS was 7.4 months (95% CI 6.2 to 8.0) and median OS was 11.0 months (95% CI 9.9 to 12.3).

Conclusions

Patients had poor clinical outcomes with a median OS of

☐ ☆ ✇ BMJ Open

Identifying provider, patient and practice factors that shape long-term opioid prescribing for cancer pain: a qualitative study of American and Australian providers

Por: Fereydooni · S. · Lorenz · K. · Azarfar · A. · Luckett · T. · Phillips · J. L. · Becker · W. · Giannitrapani · K. — Marzo 21st 2024 at 16:38
Introduction

Prescribing long-term opioid therapy is a nuanced clinical decision requiring careful consideration of risks versus benefits. Our goal is to understand patient, provider and context factors that impact the decision to prescribe opioids in patients with cancer.

Methods

We conducted a secondary analysis of the raw semistructured interview data gathered from 42 prescribers who participated in one of two aligned concurrent qualitative studies in the USA and Australia. We conducted a two-part analysis of the interview: first identifying all factors influencing long-term prescribing and second open coding-related content for themes.

Results

Factors that influence long-term opioid prescribing for cancer-related pain clustered under three key domains (patient-related, provider-related and practice-related factors) each with several themes. Domain 1: Patient factors related to provider–patient continuity, patient personality, the patient’s social context and patient characteristics including racial/ethnic identity, housing and socioeconomic status. Domain 2: Provider-related factors centred around provider ‘personal experience and expertise’, training and time availability. Domain 3: Practice-related factors included healthcare interventions to promote safer opioid practices and accessibility of quality alternative pain therapies.

Conclusion

Despite the differences in the contexts of the two countries, providers consider similar patient, provider and practice-related factors when long-term prescribing opioids for patients with cancer. Some of these factors may be categorised as cognitive biases that may intersect in an already disadvantaged patient and exacerbate disparities in the treatment of their pain. A more systematic understanding of these factors and how they impact the quality of care can inform appropriate interventions.

☐ ☆ ✇ BMJ Open

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S. — Marzo 20th 2024 at 16:56
Introduction

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

Methods and analysis

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

Ethics and dissemination

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

Trial registration number

ACTRN12622000584730.

☐ ☆ ✇ BMJ Open

Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: a propensity score-matched retrospective cohort study using the SEER database

Por: Ma · X. · Wu · S. · Zhang · X. · Chen · N. · Yang · C. · Yang · C. · Cao · M. · Du · K. · Liu · Y. — Marzo 15th 2024 at 14:25
Objectives

This study aimed to investigate the impact of adjuvant chemotherapy (ACT) on survival outcomes in older women with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2–) breast cancer (BC).

Design

A retrospective cohort study using data from the Surveillance, Epidemiology, and End Results database, which contains publicly available information from US cancer registries.

Setting and participants

The study included 45 762 older patients with BC aged over 65 years diagnosed between 2010 and 2015.

Methods

Patients were divided into two groups based on age: 65–79 years and ≥80 years. Propensity score matching (PSM) was employed to balance clinicopathological characteristics between patients who received ACT and those who did not. Data analysis used the 2 test and Kaplan-Meier method, with a subgroup analysis conducted to identify potential beneficiaries of ACT.

Outcome measures

Overall survival (OS) and cancer-specific survival (CSS).

Results

Due to clinicopathological characteristic imbalances between patients with BC aged 65–79 years and those aged ≥80 years, PSM was used to categorise the population into two groups for analysis: the 65–79 years age group (n=38 128) and the ≥80 years age group (n=7634). Among patients aged 65–79 years, Kaplan-Meier analysis post-PSM indicated that ACT was effective in improving OS (p

Conclusions

Patients with HR+/HER2– BC ≥80 years of age may be considered exempt from ACT because no benefits were found in terms of OS and CSS.

☐ ☆ ✇ BMJ Open

What do spouse primary caregivers of patients with glioblastoma want medical providers to know? A qualitative thematic reflexive analysis of letters written by primary caregivers from a secret Facebook support group

Por: Coman · D. L. · Chard · M. P. · Desautels · L. · Lutz · B. J. · Minns · L. A. — Marzo 13th 2024 at 05:20
Objectives

To analyse the content of letters written by female spouse primary caregivers of patients with glioblastoma multiforme (GBM), a devastating and terminal primary brain cancer, and give voice to their experiences for medical providers of patients with GBM.

Design

A qualitative study using reflexive thematic analysis of letters written by female spouses/life partners and primary caregivers of patients with GBM.

Participants

101 current or former female spouse primary caregivers of patients with GBM wrote letters to share with the medical community between July 2019 and August 2019. Inclusion criteria: (1) the primary caregiver who is a spouse of a patient with glioblastoma, (2) be a member of the secret Facebook group, ‘We are the wives of GBM and this is our story’, and (3) completed informed consent for the contents of their letter to be included for primary and secondary data analysis. Participants who wrote letters but did not complete the informed consent were excluded from the study.

Results

Themes from the letters included the patient experiences: (1) medical details of the disease trajectory, (2) interactions of the patient/caregiver dyads with healthcare and (3) the changing patient condition over time. Themes focused on the caregiver experiences: (1) caregiver challenges, (2) caregiver responses and (3) caregiver coping strategies, and description of tangible needs that would help other caregivers in the future. Caregiver needs were highest during the living with disease progression phase. Caregivers wanted more education and to be valued as members of the care team.

Conclusion

Shared decision-making through family-centred care would be beneficial for primary caregivers of patients with GBM. These findings provide opportunities to guide more timely and tailored interventions to provide support and improve care for patient/caregiver dyads to help mitigate the burden of this progressive disease and improve quality of life for caregivers.

☐ ☆ ✇ BMJ Open

Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)

Por: Kong · Y. · Chen · R. · Xu · M. · Zhang · J. · Chen · G. · Hong · Z. · Zhang · H. · Dai · X. · Ma · Y. · Zhao · X. · Peng · Y. · Zhang · C. · Xing · P. · Zhang · L. — Marzo 9th 2024 at 02:25
Introduction

The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.

Objective

The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.

Methods and analysis

The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.

Trial registration number

NCT05790447.

☐ ☆ ✇ BMJ Open

Development of a prognostic model for long-term survival of young patients with bladder cancer: a retrospective analysis of the SEER Database

Por: Guo · L. · Liu · L. · Liu · Y. · Yang · T. · Wang · G. · Liu · J. · Li · S. · Cai · J. — Marzo 9th 2024 at 02:25
Objectives

This study aims to present the clinical characteristics of young patients with bladder cancer (YBCa), evaluate related risk factors and construct a nomogram based on data acquired from the Surveillance, Epidemiology, and End Results (SEER) Database.

Design

Retrospective analysis of the SEER Database (2004–2015) for primary YBCa.

Setting and participants

Data for YBCa (defined as those aged 40 years or younger) were extracted from the SEER Database, which covers approximately 28% of the US population, using the SEER*Stat software (V.8.4.0.1). A total of 1233 YBCa were identified. Patients were randomly assigned to the training and validation sets. The database included clinicopathological features, demographic information and survival outcomes, such as age, gender, race, year of diagnosis, marital status at diagnosis, primary tumour site, histological type, tumour grade, tumour, node, metastases (TNM) staging, treatment regimen for the primary tumour, cause of death and survival time. A nomogram model was developed using univariate and multivariate analyses. The prediction model was validated using the consistency index (C-index), calibration curve and receiver operating characteristic curve.

Primary outcome measures

3-year, 5-year and 10-year overall survival (OS).

Results

1233 YBCa from 2004 to 2015 were randomly assigned to the training set (n=865) and validation set (n=368). Age, marital status, tumour grade, histological type and TNM staging were included in the nomogram. The C-index of the model was 0.876. The 3-year, 5-year and 10-year OS area under the curve values for the training and validation sets were 0.949, 0.923 and 0.856, and 0.919, 0.890 and 0.904, respectively. Calibration plots showed that the nomogram had a robust predictive accuracy.

Conclusions

To our knowledge, this is the first study to establish a precise nomogram predicting the 3-year, 5-year and 10-year OS in YBCa based on multivariate analyses. Our nomogram may serve as a valuable reference for future diagnostics and individualised treatments for YBCa. However, external validation is warranted to assess the accuracy and generalisability of our prognostic model.

☐ ☆ ✇ BMJ Open

Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol

Por: Ho · C. · Ha · N. T. · Youens · D. · Abhayaratna · W. P. · Bulsara · M. K. · Hughes · J. D. · Mishra · G. · Pearson · S.-A. · Preen · D. B. · Reid · C. M. · Ruiter · R. · Saunders · C. M. · Stricker · B. H. · van Rooij · F. J. A. · Wright · C. · Moorin · R. — Marzo 9th 2024 at 02:25
Introduction

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

Methods and analysis

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethics and dissemination

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

Trial registration number

NCT05972785.

☐ ☆ ✇ BMJ Open

Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L. — Marzo 9th 2024 at 02:25
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

☐ ☆ ✇ BMJ Open

Efficacy of a digital lifestyle intervention on health-related QUAlity of life in non-small cell LUng CAncer survivors following inpatient rehabilitation: protocol of the QUALUCA Swiss multicentre randomised controlled trial

Por: Weber · M. · Raab · A. M. · Schmitt · K.-U. · Büsching · G. · Marcin · T. · Spielmanns · M. · Puhan · M. A. · Frei · A. — Marzo 7th 2024 at 10:14
Introduction

Non-small cell lung cancer (NSCLC) survivors suffer from impaired physical and psychological functioning and reduced health-related quality of life (HRQoL) that persist after active treatment ends. Sustaining rehabilitation benefits, promoting a healthy lifestyle and facilitating self-management at home require a multifaceted aftercare programme. We aim to investigate the effect of a 12-week digital lifestyle intervention on HRQoL and lifestyle-related outcomes in NSCLC survivors after completion of inpatient rehabilitation.

Methods and analysis

QUAlity of life in LUng CAncer Survivors (QUALUCA) is a multicentre randomised controlled trial that follows a hybrid type 1 design. We randomly allocate participants in a 1:1 ratio to the intervention group (digital lifestyle intervention) or the control group (standard care) using block randomisation stratified by tumour stage and study site. Four accredited Swiss inpatient rehabilitation centres recruit participants. Key inclusion criteria are a diagnosis of NSCLC, an estimated life expectancy of ≥6 months and access to a smartphone or tablet. The 12-week intervention comprises physical activity, nutrition and breathing/relaxation, delivered through a mobile application (app). The primary outcome is the change in HRQoL from baseline (1 week after rehabilitation) to follow-up (3 months after baseline), assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Secondary outcomes include body mass index, self-reported physical activity, exercise capacity, risk of low protein intake, appetite, psychological distress, cancer-related fatigue, enablement and self-rated health. Explanatory outcomes in the intervention group include app usability, acceptability, appropriateness, and feasibility of the intervention, experiences and satisfaction with the intervention, and app usage data. We aim to enrol 88 participants. For the main statistical analysis, we will use analysis of covariance, adjusted for baseline measures, stratification variables, age and sex.

Ethics and dissemination

The Ethics Committees of the Canton of Zurich (lead), the Canton of Bern and Northwest and Central Switzerland approved the study (2023-00245). We will disseminate study results to researchers, health professionals, study participants and relevant organisations, and through publications in international peer-reviewed journals.

Trial registration number

NCT05819346.

☐ ☆ ✇ BMJ Open

Scoping review protocol of post-traumatic growth (PTG) in Korean cancer survivors

Por: Park · Y.-J. · Lee · K. S. — Marzo 6th 2024 at 05:12
Introduction

Cancer, a life-threatening chronic disease, is the leading cause of death in Korea, accounting for 27% of all deaths in 2020. Due to advancements in medical technology and early detection of cancer in Korea, the 5-year relative survival rate reached 70.7% (2015–2019), highlighting remarkable progress over the past decades. Although cancer has been seen as a traumatic event, cancer survivors also go through a subjective process of self-maturation, which is called post-traumatic growth (PTG). Because research on PTG among Korean cancer survivors has not been systematically synthesised, a scoping review on this topic will provide a better understanding of the positive psychological changes that occur as a patient moves through the illness trajectory of cancer from a Korean cultural perspective. The purpose of this study was to describe the protocol of a scoping review regarding PTG in Korean cancer survivors.

Methods and analysis

The scoping review framework suggested by Arksey and O’Malley and the manual refined by the Joanna Briggs Institute for scoping reviews will be used with the six framework guidelines developed by Levac et al. Searched databases will include Ovid-MEDLINE, PubMed, Embase, CINAHL, Cochrane Library and PsycInfo, as well as Korean databases, examining all articles published between 2012 and 2023 in Korean or English on PTG in Korean cancer survivors. Extracted data will be collated, charted and summarised.

Ethics and dissemination

Because the scoping review methodology undertakes a secondary analysis of collected data from previous research studies, this study does not require ethical approval. The results of this scoping review will be disseminated through presentations at conferences and publication in a scientific journal.

☐ ☆ ✇ BMJ Open

Barriers And Challenges Of Multidisciplinary Teams In Oncology Management: A Scoping Review Protocol

Por: Law · N. L. W. · Hong · L. W. · Tan · S. S. N. · Foo · C. J. · Lee · D. · Voon · P. J. — Febrero 10th 2024 at 11:42
Introduction

Multidisciplinary teams (MDTs) are integral to oncology management, involving specialised healthcare professionals who collaborate to develop individualised treatment plans for patients. However, as cancer care grows more complex, MDTs must continually adapt to better address patient needs. This scoping review will explore barriers and challenges MDTs have encountered in the past decade; and propose strategies for optimising their utilisation to overcome these obstacles and improve patient care.

Methods and analysis

The scoping review will follow Arksey and O’Malley’s framework and begin with a literature search using keywords in electronic databases such as PubMed/MEDLINE, Scopus and PsychINFO, covering the period from January 2013 to December 2022 and limited to English language publications. Four independent reviewers will screen titles and abstracts based on predefined inclusion criteria, followed by full-text review of selected titles. Relevant references cited in the publications will also be examined. A Preferred Reporting Items for Systematic reviews and Meta-Analyses flow diagram will be utilised to illustrate the methodology. Data from selected publications will be extracted, analysed, and categorised for further analysis.

Ethics and dissemination

The results of the scoping review will provide a comprehensive overview of the barriers and challenges encountered by oncology MDTs over the past decade. These findings will contribute to the existing literature and provide insights into areas that require improvement in the functioning of MDTs in oncology management. The results will be disseminated through publication in a scientific journal, which will help to share the findings with the wider healthcare community and facilitate further research and discussion in this field.

Trial registration details

The protocol for this scoping review is registered with Open Science Framework, available at DOI 10.17605/OSF.IO/R3Y8U.

☐ ☆ ✇ BMJ Open

Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol

Por: Wu · L. · Yan · H. · Qin · Y. · Huang · M. · Wang · T. · Jin · Q. · Wei · W. — Febrero 10th 2024 at 11:42
Introduction

Curing locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ) with surgery alone is challenging. Neoadjuvant chemotherapy (NCT) has become the standard treatment for patients with locally advanced GC/GEJ, and SOX is the most common neoadjuvant regimen in China. The generally good tolerability in patients and fruquintinib’s low potential for drug–drug interaction suggest that it may be highly suitable for combinations with other antineoplastic therapies. A combination of fruquintinib, S-1 and oxaliplatin can be a promising neoadjuvant treatment for locally advanced GC/GEJ. In this phase II study, we aim to investigate the efficacy and toxicity of fruquintinib plus SOX as neoadjuvant treatment for locally advanced GC/GEJ.

Methods and analysis

The FRUTINEOGA trial is a prospective, multicentre, phase II, single-arm, open-label clinical trial that will enrol 54 patients. Eligible patients will be registered, enrolled and receive 2–4 cycles of fruquintinib plus SOX, after which surgery will be performed and tumour regression will be evaluated. The primary endpoint is the pathological remission rate, and the secondary endpoints are disease-free survival, overall survival, objective response rate, major pathological response rate and R0 resection rate.

Ethics and dissemination

Written informed consent will be required from all patients enrolled, and it will be provided by them. The study protocol received approval from the independent ethical review committee of Guangxi Medical University Cancer Hospital, Wuming Hospital of Guangxi Medical University and Wuzhou Red Cross Hospital, Wuzhou Gongren Hospital (approval number: CS2021(96)). We will submit the finalised paper for publication on completing the analyses. This study will provide valuable insights to clinicians regarding the safety and efficacy of incorporating fruquintinib into SOX as neoadjuvant treatment for locally advanced GC/GEJ. The findings have the potential to inform future research proposals and may guide the use of fruquintinib in the neoadjuvant setting for locally advanced GC/GEJ.

Trial registration number

NCT05122091.

☐ ☆ ✇ BMJ Open

Role of HDL cholesterol in anthracycline-induced subclinical cardiotoxicity: a prospective observational study in patients with diffuse large B-cell lymphoma treated with R-CHOP

Por: Ou · W. · Jiang · T. · Zhang · N. · Lu · K. · Weng · Y. · Zhou · X. · Wang · D. · Dong · Q. · Tang · X. — Febrero 10th 2024 at 11:42
Objectives

Anthracycline-induced cardiotoxicity is a debilitating cardiac dysfunction for which there are no effective treatments, making early prevention of anthracycline-induced subclinical cardiotoxicity (AISC) crucial. High-density lipoprotein cholesterol (HDL-C) plays a role in cardioprotection, but its impact on AISC remains unclear. Our study aims to elucidate the protective capacity of HDL-C in AISC in patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP (cyclophosphamide, vincristine, doxorubicin, prednisone and rituximab).

Design

Prospective observational study.

Setting

Conducted in China from September 2020 to September 2022.

Participants

70 chemotherapy-naïve patients newly diagnosed with DLBCL who were scheduled to receive the standard dose of R-CHOP; 60 participants included in a case–control study (DOI: 10.1186/s12885-022-10085-6).

Primary outcome measures

Serum biomarkers, 2D speckle tracking echocardiography and conventional echocardiography were measured at baseline, at the end of the third and sixth cycles of R-CHOP and 6 and 12 months after chemotherapy.

Results

24 patients experienced AISC, while 10 did not. 36 patients were lost to follow-up and death. Cox regression analysis showed that higher levels of HDL-C were associated with a significantly lower risk of AISC (unadjusted HR=0.24, 95% CI 0.09 to 0.67, p=0.006; adjusted HR=0.27, 95% CI 0.09 to 0.79, p=0.017). Patients without AISC had a more stable and higher HDL-C level during the follow-up period. HDL-C levels significantly decreased from the end of the third cycle of chemotherapy to the end of the sixth cycle of chemotherapy in all patients (p=0.034), and particularly in the AISC group (p=0.003). The highest level of HDL-C was significantly higher in patients without AISC than in those with AISC (1.52±0.49 vs 1.22±0.29, p=0.034).

Conclusions

Our study suggests that higher HDL-C levels may associate with lower AISC risk in patients with DLBCL treated with R-CHOP. HDL-C could be a cardioprotective target, but further research is needed to confirm its benefits and limitations.

Study registration number

Study registration number: ChiCTR2100054721

☐ ☆ ✇ BMJ Open

Adequacy of cancer-related pain management using the Pain Management Index among patients with cancer in the Northwest oncology centres of Ethiopia: an institutional-based cross-sectional study

Por: Mihiretie · E. A. · Siyum · T. S. · Tamene · F. B. — Febrero 9th 2024 at 02:19
Objective

The aim of this study was to assess the adequacy of cancer-related pain (CRP) management and associated factors among patients with cancer in the Northwest oncology centres of Ethiopia.

Design and setting

An institutional-based multicentre cross-sectional study was conducted among patients with cancer in the Northwest oncology centres of Ethiopia from May to July 2022.

Participants

All oncology patients at selected hospitals who fulfilled the inclusion criteria during the data collection period were the study population.

Main outcome measures

The main outcome of this study was the adequacy of CRP management, which was measured by the Pain Management Index (PMI). A systematic random sampling technique was used to select representatives from each study area. Data entry and analysis were done using EpiData V.4.6.1 and SPSS V.26, respectively. Binary logistic regression was conducted to determine independent predictors of the adequacy of CRP management. A p value of

Results

From a total of 422 included respondents, about 67.5% of the participants had adequate CRP management (95% CI 62.8 to 72). Good performance status (adjusted OR (AOR)=0.44; 95% CI 0.24 to 0.80), presence of comorbidity (AOR=3.28; 95% CI 1.68 to 6.38) and pain history (AOR=0.33; 95% CI 0.01 to 0.11) were significantly associated with the adequacy of cancer pain management.

Conclusion

Using PMI status in the Northwest oncology centre of Ethiopia, more than two-thirds of patients with CRP obtained adequate pain management. The adequacy of CRP management was found to be influenced by factors like comorbidity, past pain history and Eastern cooperative oncology group performance status.

☐ ☆ ✇ BMJ Open

VersKiK qualitative study design: actual follow-up needs of paediatric cancer survivors, their informal caregivers and follow-up stakeholder perceptions in Germany

Por: Aleshchenko · E. · Swart · E. · Voigt · M. · Langer · T. · Calaminus · G. · Glogner · J. · Baust · K. — Febrero 8th 2024 at 03:36
Introduction

This article presents the study design of the qualitative part of the VersKiK study (Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence: study protocol of a large scale multi-methods non-interventional study) aiming to explore actual follow-up needs of childhood and adolescence cancer survivors and their informal caregivers, gaps in current follow-up care provision and trajectories of cancer survivors’ transition from paediatric to adult healthcare.

Methods and analysis

We will conduct up to 30 interviews with survivors of childhood and adolescence cancer and their informal caregivers with up to 20 participant observations of follow-up appointments. The results of these will be discussed in up to four focus groups with healthcare professionals and representatives of self-help groups. The study design aims to evaluate follow-up care after childhood cancer considering perspectives from survivors, their informal caregivers as well as healthcare providers. The combination of different data sources will allow us to get an in-depth understanding of the current state of follow-up care after paediatric cancer in Germany and to suggest recommendations for care improvement.

Ethics and dissemination

The VersKiK study was approved by the Ethics Committee Otto von Guericke University on 2 July 2021 (103/21), by the Ethics Committee of Johannes Gutenberg University Mainz on 16 June 2021 (2021-16035), by the Ethics Committee University of Lübeck on 10 November 2021 (21-451), by the Ethics Committee University of Hospital Bonn on 28 February 2022 (05/22). For each part of the qualitative study, a separate written informed consent is prepared and approved accordingly by the ethics committees named above.

Trial registration number

Registered at German Clinical Trial Register, ID: DRKS00026092.

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