Follow-up care is important for gastric cancer survivors, but follow-up strategies for gastric cancer survivors remain inconsistent, and compliance of gastric cancer survivors with follow-up care is very low. Understanding the needs and preferences of gastric cancer survivors is conducive to developing appropriate and acceptable follow-up strategies, thereby improving patient compliance. Discrete choice experiments can quantify individual needs and preferences. However, to date, there is no discrete choice experiment on the preferences of gastric cancer survivors, and no studies have examined how gastric cancer survivors make choices based on different characteristics of follow-up. This paper outlines an ongoing discrete choice experiment that aims to (1) explore follow-up service-related characteristics that may affect gastric cancer survivors’ choices about their follow-up, (2) elicit how gastric cancer survivors consider the trade-offs among different follow-up service options using discrete choice experiment, (3) determine whether gastric cancer survivors’ needs and preferences for follow-up vary due to the economy, politics, technology and culture in different regions.
Six attributes were developed through a literature review, semistructured interviews and experts and focus group discussions. A fractional factorial design was used to evaluate the interaction between attributes. A multiple logit model will be used to understand the trade-off between the follow-up characteristics of gastric cancer survivors. A mixed logit model will be used to explore the willingness to pay and uptake rate of gastric cancer survivors for follow-up attributes and further explore the preferences of different groups.
This study was approved by the ethics committee of the School of Nursing, Jilin University. The results of this study will be shared through online blogs, policy briefs, seminars and peer-reviewed journal articles and will be used to modify the current strategy of gastric cancer survivors’ follow-up services according to economic development and regional culture.
Radiotherapy has become one of the main methods used for the treatment of malignant tumours of the head and neck. Spiral tomographic intensity-modulated radiotherapy has the many advantages of precision radiotherapy, which puts forward high requirements for postural reproducibility and accuracy. We will aim to ensure that the accurate positioning of the tumour will reduce the side effects of radiotherapy caused by positioning errors. We will design and implement this clinical trial using the patent of ‘a radiotherapy oral fixation and parameter acquisition device (patent number: ZL201921877986.5)’.
This will be a randomised, controlled, prospective study with 120 patients with head and neck tumours. Using the random number table method, a random number sequence will be generated, and the patients will be enrolled in the experimental group (oral fixation device) and the control group (conventional fixation) in a 2:1 ratio. The primary outcome will be the progression-free survival time after the treatment. Secondary outcomes will include the oral mucosal reaction and the quality of life. Follow-ups will be carried out according to the plan. This is V.1.0 of protocol on 1 April 2021. The recruitment process for this clinical trial commenced on 1 May 2021, and will end on 1 October 2022.
The trial received ethical approval from Medical Ethics Committee of Liaoning Provincial Cancer Hospital (number 20210131X). The final results will be presented at a scientific conference and published in a peer-reviewed journal in accordance with the journal’s guidelines.
Intimate partners of patients with cancer often experience significant distress, but there is a lack of psychological interventions that specifically target this population. ‘Resilient Caregivers’ is a novel resilience-based intervention for distressed partner cancer caregivers. The intervention was developed according to a resilience framework focusing on meta-reflective skills, coping strategies and value clarification. The aim of this study is to evaluate the effectiveness of this intervention in a randomised trial.
Eighty participants will be invited through the Oncology Department at Herlev Hospital, Denmark and randomised to either the intervention or usual care. Participants are eligible if they are partners (married or unmarried) of patients diagnosed with cancer and experience distress (>4 on the distress thermometer). ‘Resilient Caregivers’ consists of seven manualised group sessions (2.5 hours each), focusing on resilience in relation to being a partner caregiver of a patient with cancer. The primary outcome is symptoms of anxiety, while secondary outcomes include distress, depression, quality of life, sleep quality and resilience. Data will be collected at baseline, 3, 6 and 12 months follow-up using validated scales, and analysed using mixed models for repeated measures.
This study will follow the ethical principles in the Declaration of Helsinki and has been reviewed by the Ethics Committee of the Capital Region of Denmark (Journal no. 18055373). Written informed consent will be obtained from all participants. Results will be reported through scientific peer-reviewed journals and relevant conferences.
There is no consensus on the optimal treatment strategy for people with advanced endometrial cancer. Neoadjuvant therapies such as chemotherapy and radiotherapy have been employed to try to reduce the morbidity of surgery, improve its feasibility and/or improve functional performance in people considered unfit for primary surgery. The objective of this review is to assess whether neoadjuvant chemotherapy or radiotherapy improves health outcomes in people with advanced endometrial cancer when compared with upfront surgery.
This review will consider both randomised and non-randomised studies that compare health outcomes associated with the neoadjuvant therapy and upfront surgery in advanced endometrial cancer. Potential studies for inclusion will be collated from electronic searches of OVID Medline, Embase, international trial registries and conference abstract lists. Data collection and extraction will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The methodological quality of the studies will be assessed using the Risk of Bias 2 and Risk of Bias in Non-randomised Studies of Interventions tools. If appropriate, we will perform a meta-analysis and provide summary statistics for each outcome.
Ethics approval was not required for this study. Once complete, we will publish our findings in peer-reviewed publications, via conference presentations and to update relevant practice guidelines.
The findings reported in this manuscript are part of a wider study that aimed to explore mesothelioma patients’ experiences of follow-up care. The aim of this phase of the study was to co-produce recommendations for policy and practice and to propose a revised, patient-focused, mesothelioma follow-up care service.
The consultation phase was qualitative and consisted of three group discussions with separate stakeholder groups allowing for different priorities and needs for follow-up care to be compared. An implicit approach to consensus was adopted and data were analysed iteratively using the framework method.
The study was conducted in three National Health Service Trusts in the South of England. Two were secondary care settings and the third was a tertiary centre.
The consultation exercise comprised three group discussions with key stakeholders (n=35): mesothelioma specialist nurses (n=9), mesothelioma patients and carers (n=11) and local clinical commissioning group members (n=15).
Recommendations for mesothelioma follow-up care were developed using a co-production approach and highlighted the importance of continuity of care, the provision of timely information and the central role played by mesothelioma specialist nurses, supported by the wider multidisciplinary team. Recommendations were produced together with two bespoke infographics to maximise impact and facilitate patient and public engagement with the study.
The recommendations developed are the first that specifically examine best practice for the follow-up care pathway for mesothelioma patients. Co-production and public engagement are crucial to priority setting develop and optimising patient-centred care. Combining the recommendations produced with a targeted dissemination strategy and well-designed, patient-focused infographics will maximise opportunities for impact at a regional and national level.
To summarise the current evidence regarding interventions for accurate and timely cancer diagnosis among symptomatic individuals.
A scoping review following the Joanna Briggs Institute’s methodological framework for the conduct of scoping reviews and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist.
MEDLINE (Ovid), CINAHL (EBSCOhost) and PsycINFO (Ovid) bibliographic databases, and websites of relevant organisations. Published and unpublished literature (grey literature) of any study type in the English language were searched for from January 2017 to January 2021.
Study participants were individuals of any age presenting at clinics with symptoms indicative of cancer. Interventions included practice guidelines, care pathways or other initiatives focused on achieving predefined benchmarks or targets for wait times, streamlined or rapid cancer diagnostic services, multidisciplinary teams and patient navigation strategies. Outcomes included accuracy and timeliness of cancer diagnosis.
We summarised findings graphically and descriptively.
From 21 298 retrieved citations, 88 unique published articles and 16 unique unpublished documents (on 18 study reports), met the eligibility for inclusion. About half of the published literature and 83% of the unpublished literature were from the UK. Most of the studies were on interventions in patients with lung cancer. Rapid referral pathways and technology for supporting and streamlining the cancer diagnosis process were the most studied interventions. Interventions were mostly complex and organisation-specific. Common themes among the studies that concluded intervention was effective were multidisciplinary collaboration and the use of a nurse navigator.
Multidisciplinary cooperation and involvement of a nurse navigator may be unique features to consider when designing, delivering and evaluating interventions focused on improving accurate and timely cancer diagnosis among symptomatic individuals. Future research should examine the effectiveness of the interventions identified through this review.
Considerable observational evidence suggests that cancer online support groups reduce feelings of isolation, depression and anxiety, enhance coping and self-management, and lead to better informed patients. Other studies indicate that cancer online support groups can increase distress. Yet no studies theorise the complex, context-dependent mechanisms by which cancer online support groups generate their—sometimes contrasting—outcomes.
Guided by an integrated knowledge translation approach and the strategy for patient-oriented research, we will conduct a realist review of cancer online support groups in partnership with stakeholders. We will follow Pawson’s five steps and existing quality standards to develop a program theory that explains how cancer online support groups work, for whom and in what circumstances. The specific research questions will be: what positive and negative outcomes have been reported on cancer online support groups? What are the mechanisms that are associated with these outcomes, in which contexts and for whom? Through a rigorous review of relevant scientific and grey literature, as well as ongoing dialogue with stakeholders, a program theory will be developed to explain who benefits from cancer online support groups and who does not, what benefits they derive (or do not), and the factors that affect these outcomes.
The use of secondary data for this review precludes the need for ethical approval. Dissemination will be informed by the knowledge-to-action framework and will consist of tailored knowledge products that are conceived of collaboratively with stakeholders. These will include peer-reviewed publications on how cancer online support groups can be optimised and best practice recommendations to maximise the benefits experienced by people with cancer. These traditional scientific outputs, along with their respective evidence summaries, will be amplified through strategic social media events hosted and promoted by knowledge users.
Recent studies have reported a correlation between non-coding RNAs such as circular RNAs (circRNAs) and clinical value of various cancers. However, the diagnostic and prognostic role of circRNA in breast cancer remains controversial.
Systematic review and meta-analysis.
Diagnostic efficacy was estimated by sensitivity, specificity and area under the curve (AUC). Pooled HRs with 95% CIs estimated overall survival (OS), and ORs with 95% CIs investigated clinical features.
By searching PubMed, Embase, Web of Science, CNKI and Cochrane Library, we obtained a total of 29 studies with 4405 patients. A shorter survival time was associated with high expression levels of tumour-promoter circRNAs (OS: HR=2.43, 95% CI 2.20 to 2.92, p
Dysregulated expression of circRNA was related to diagnosis and prognosis in breast cancer, which indicated it might be a novel biomarker and a target of therapy for breast cancer.
We evaluated the temporal trend in gender ratios of first and last authors in the field of oncological research published in major general medical and oncology journals and examined the gender pattern in coauthorship.
We conducted a retrospective study in PubMed using the R package RISmed. We retrieved original research articles published in four general medical journals and six oncology specialty journals. These journals were selected based on their impact factors and popularity among oncologists. We identified the names of first and last authors from 1 January 2002 to 31 December 2019. The gender of the authors was identified and validated using the Gender API database (https://gender-api.com/).
The percentages of first and last authors by gender and the gender ratios (male to female) and temporal trends in gender ratios of first and last authors were determined.
We identified 34 624 research articles, in which 32 452 had the gender of both first and last authors identified. Among these 11 650 (33.6%) had women as the first author and 7908 (22.8%) as the last author, respectively. The proportion of female first and last authors increased from 26.6% and 16.2% in 2002, to 32.9% and 27.5% in 2019, respectively. However, the gender ratio (male to female) of first and last authors decreased by 1.5% and 2.6% per year, respectively, which were statistically significant (first author: incidence rate ratio (IRR) 0.98, 95% CI 0.97 to 1.00; last author: IRR 0.97, 95% CI 0.96 to 0.99). Male first and last authorship was the most common combination. Male–female and female–female pairs increased by 2.0% and 5.0%, respectively (IRR 1.02, 95% CI 1.01 to 1.03 and IRR 1.05, 95% CI 1.04 to 1.06, respectively).
The continued under-representation of women means that more efforts to address parity for advancement of women in academic oncology are needed.
For patients with cancer, immune checkpoint inhibitors (ICIs) produce superior long-term responses compared with alternative treatments, although at the cost of manifesting adverse immune-related events. There are many hypotheses of the impacts of physical activities in immunotherapy, but little is known about the oncological outcomes and the underlying mechanisms. This scoping review aims to identify possible physical activity interventions, their efficacy and feasibility and the potential underlying biological mechanisms responsible for their effects.
The Levac methodology framework was used along with guidance from the Joanna Briggs Institute Manual for Evidence Synthesis to inform development of this protocol. Abstracts and titles followed by full-text screening will be performed by two independent reviewers for inclusion. All studies describing the impact of physical activities and exercise interventions on cancer ICIs, with particular focus on oncological outcomes, quality of life or underling biological mechanisms, will be included. After extracting qualitative and quantitative data, they will be evaluated and summarised, respectively. Subsequently, a further consultation step with other scientists and healthcare professionals will be performed.
The research findings will be published through an open-access peer-reviewed journal. The results of this scoping review will be used to inform further studies on physical impacts on immunotherapy. All data included will be from open resources, therefore, no ethical clearances are required.
Patients with multiple myeloma (MM) experience significant delays in diagnosis due to non-specific symptomatology. The aim of this study was to characterise the frequency and timing of clinical features in the primary care setting prior to MM diagnosis.
Population-based cohort study.
Electronic health records data of approximately 17 million patients (2006–2016) within the UK Clinical Practice Research Datalink.
Patients aged ≥18 years with newly diagnosed MM (NDMM), no history of solid tumours and ≥2 years registration in a primary care practice prior to MM diagnosis.
Clinical features and symptoms including bone pain, skeletal-related events (SREs), investigation and confirmation of MM diagnostic CRAB criteria (hyperCalcaemia, Renal impairment, Anaemia, Bone lesions) during the 2 years prior to MM diagnosis; time between symptom manifestation and/or relevant investigation and diagnosis of MM.
Among 2646 patients with NDMM, 47.5% had a bone pain record during the 2-year period prior to MM diagnosis, mainly affecting the back. Regardless of baseline bone pain, investigations for serum calcium level were used in 36.4% of patients prior to MM diagnosis, followed by haemoglobin (65.6%) or renal function (74.1%). Median (Q1, Q3) time from first-recorded bone pain to MM diagnosis was 220 (80, 476) days. Median (Q1, Q3) time from first-recorded hypercalcaemia, renal impairment or anaemia to MM diagnosis was 23 (12, 46), 58 (17, 254) and 73 days (28, 232), respectively. An imaging investigation or referral for imaging was recorded for 60.0% of patients with bone pain/SRE and 32% without.
Nearly half of patients diagnosed with NDMM presented with bone pain approximately 7 months prior to MM diagnosis. Investigations to evaluate all CRAB criteria, including targeted imaging, were underused. Early recognition of myeloma clinical features and optimised use of investigations in primary care may potentially expedite MM diagnosis.
Cancer survival rates have improved over the past few decades, yet socioeconomic disparities persist. Social determinants of health (SDOH) have consistently been shown to correlate with health outcomes. The objective of this study was to characterise oncologists’ perceptions of the impact of SDOH on their patients, and their opinions on how these effects could be remediated.
Cross-sectional survey of physicians.
Web-based survey completed prior to live meetings held between February and April 2020.
Oncologists/haematologists from across the USA.
Clinical practice in a community-based or hospital-based setting.
Physician responses regarding how SDOH affected their patients, which factors represented the most significant barriers to optimal health outcomes and how the impact of SDOH could be mitigated through assistance programmes.
Of the 165 physicians who completed the survey, 93% agreed that SDOH had a significant impact on their patients’ health outcomes. Financial security/lack of insurance and access to transportation were identified most often as the greatest barriers for their patients (83% and 58%, respectively). Eighty-one per cent of physicians indicated that they and their staff had limited time to spend assisting patients with social needs, and 76% reported that assistance programmes were not readily accessible. Government organisations, hospitals, non-profit organisations and commercial payers were selected by 50% or more of oncologists surveyed as who should be responsible for delivering assistance programmes to patients with social needs; 42% indicated that pharmaceutical manufacturers should also be responsible.
Our survey found that most oncologists were aware of the impact of SDOH on their patients but were constrained in their time to assist patients with social needs. The physicians in our study identified a need for more accessible assistance programmes and greater involvement from all stakeholders in addressing SDOH to improve health outcomes.
The study aimed to explore patients’ experiences of experimental cancer medicine (ECM) clinical trials.
The study’s design was qualitative. Two focus groups with patients were undertaken followed by semistructured interviews, to explore patients’ experiences of ECM clinical trials. Interviews and focus groups were audiorecorded and transcribed verbatim. Data were analysed using thematic analysis.
A regional cancer centre (tertiary care) in North-West England.
Twelve patients (aged 52–79) participated in one of the two focus groups and 22 patients (aged 42–83) participated in interviews.
Patients’ experiences of an ECM trial.
Four main themes were identified from the analysis: decision making, information needs, the experience of trial participation and impact of trial participation. Subthemes are presented in the manuscript.
To make fully informed decisions about trial participation, patients required the simplification of trial information and wanted more information about side effects, their response to trial treatment and the overall trial progress throughout the trial. Patients highlighted the need for improvement for the support provided to their family and friends.
While the socioeconomic impact of a cancer diagnosis on cancer survivors has gained some attention in the literature, to our knowledge, a review of the evidence on changes in income due to cancer has yet to be undertaken. In this paper, we describe a scoping review protocol to review the evidence on the effect of a cancer diagnosis on the income of individuals diagnosed with cancer during adulthood (≥18 years). The purpose is to summarise existing evidence, identify gaps in current research and highlight priority areas for future research.
This study will follow the methodological framework for conducting scoping reviews by the Joanna Briggs Institute In collaboration with a health science librarian, we developed a search strategy to be performed in Ovid MEDLINE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Econ-Literature and Evidence-Based Medicine Reviews. This scoping review will search the scientific literature published in English from 1 January 2000 to 31 December 2020. Studies that measured the impact of cancer on income of adults will be eligible for inclusion. Studies exclusively focused on employment outcomes (eg, return to work, unemployment, productivity loss), financial expenditures, childhood cancer survivors and/or the caregivers of cancer survivors will be excluded. Three independent reviewers will conduct screening and extract data. Descriptive information will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for Scoping Reviews.
This scoping review will analyse data from publicly available materials and thus does not require ethics approval. Results from this review will be disseminated through a peer-reviewed publication and/or conference presentation with the potential to identify gaps in the literature, suggest strategies for standardised terminology and provide directions for future research.
To understand self-reported potential cancer symptom help-seeking behaviours and attitudes during the first 6 months (March–August 2020) of the UK COVID-19 pandemic.
UK population-based survey conducted during August and September 2020. Correlates of help-seeking behaviour were modelled using logistic regression in participants reporting potential cancer symptoms during the previous 6 months. Qualitative telephone interviews with a purposeful subsample of participants, analysed thematically.
Online UK wide survey.
7543 adults recruited via Cancer Research UK online panel provider (Dynata) and HealthWise Wales (a national register of ‘research ready’ participants) supplemented with social media (Facebook and Twitter) recruitment. 30 participants were also interviewed.
Survey measures included experiences of 15 potential cancer symptoms, help-seeking behaviour, barriers and prompts to help-seeking.
Of 3025 (40.1%) participants who experienced a potential cancer symptom, 44.8% (1355/3025) had not contacted their general practitioner (GP). Odds of help-seeking were higher among participants with disability (adjusted OR (aOR)=1.38, 95% CI 1.11 to 1.71) and who experienced more symptoms (aOR=1.68, 95% CI 1.56 to 1.82), and lower among those who perceived COVID-19 as the cause of symptom(s) (aOR=0.36, 95% CI 0.25 to 0.52). Barriers included worries about wasting the doctor’s time (1158/7543, 15.4%), putting strain on healthcare services (945, 12.6%) and not wanting to make a fuss (907, 12.0%). Interviewees reported reluctance to contact the GP due to concerns about COVID-19 and fear of attending hospitals, and described putting their health concerns on hold.
Many people avoided healthcare services despite experiencing potential cancer symptoms during the COVID-19 pandemic. Alongside current help-seeking campaigns, well-timed and appropriate nationally coordinated campaigns should signal that services are open safely for those with unusual or persistent symptoms.
To report characteristics, treatment and overall survival (OS) trends, by stage and pathology, of patients diagnosed with non-small cell lung cancer (NSCLC) at Leeds Teaching Hospital NHS Trust in 2007–2018.
Retrospective cohort study based on electronic medical records.
Large NHS university hospital in Leeds.
3739 adult patients diagnosed with incident NSCLC from January 2007 to August 2017, followed up until March 2018.
Patient characteristics at diagnosis, treatment patterns and OS.
34.3% of patients with NSCLC were clinically diagnosed (without pathological confirmation). Among patients with known pathology, 45.2% had non-squamous cell carcinoma (NSQ) and 33.3% had squamous cell carcinoma (SQ). The proportion of patients diagnosed at stage I increased (16.4%–27.7% in 2010–2017); those diagnosed at stage IV decreased (57.0%–39.1%). Surgery was the most common initial treatment for patients with pathologically confirmed stage I NSCLC. Use of radiotherapy alone increased over time in patients with clinically diagnosed stage I NSCLC (39.1%–60.3%); chemoradiation increased in patients with stage IIIA NSQ (21.6%–33.3%) and SQ (24.2%–31.9%). Initial treatment with systemic anticancer therapy (SACT) increased in patients with stages IIIB–IV NSQ (49.0%–67.5%); the proportion of untreated patients decreased (30.6%–15.0%). Median OS improved for patients diagnosed with stage I NSQ and SQ and stage IIIA NSQ over time. Median OS for patients with stages IIIB–IV NSQ and SQ remained stable,
OS for stage I and IIIA patients improved over time, likely due to increased use of stereotactic ablative radiation, surgery (stage I) and chemoradiation (stage IIIA). Conversely, OS outcomes remained poor for stage IIIB–IV patients despite increasing use of SACT for NSQ. Many patients with advanced-stage disease remained untreated.
Despite safety and benefits of physical activity during treatment of localised breast cancer, successful exercise strategies remain to be determined. The primary objective of the ‘dispositif connecté’, that is, connected device in English trial is to evaluate the efficacy of two 6-month exercise interventions, either single or combined, concomitant to adjuvant treatments, on the physical activity level of patients with breast cancer, compared with usual care: an exercise programme using a connected device (activity tracker, smartphone application, website) and a therapeutic patient education intervention. Secondary objectives are to evaluate adherence to interventions, their impact at 6 and 12 months, representations and acceptability of interventions, and to assess the cost-effectiveness of the interventions using quality-adjusted life-years.
This is a 2x2 factorial, multicentre, phase III randomised controlled trial. The study population (with written informed consent) will consist of 432 women diagnosed with primary localised invasive breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy and/or radiotherapy. They will be randomly allocated between one of four arms: (1) web-based connected device (evolving target number of daily steps and an individualised, semisupervised, adaptive programme of two walking and one muscle strengthening sessions per week in autonomy), (2) therapeutic patient education (one educational diagnosis, two collective educational sessions, one evaluation), (3) combination of both interventions and (4) control. All participants will receive the international physical activity recommendations. Assessments (baseline, 6 and 12 months) will include physical fitness tests, anthropometrics measures, body composition (CT scan, bioelectrical impedance), self-administered questionnaires (physical activity profile (Recent Physical Activity Questionnaire), quality of life (European Organization for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30, EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation (Evaluation of Deprivation and Inequalities in Health Examination Centres), lifestyle, physical activity barriers, occupational status) and biological parameters (blood draw).
This study was reviewed and approved by the French Ethics Committee. The findings will be disseminated to the scientific and medical community via publications in peer-reviewed journals and conference presentations.
Lung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands.
The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness.
The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy.
Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding.
The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences.
Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897.
Breast cancer is the most frequently diagnosed malignancy worldwide but almost half of the patients have an excellent prognosis with a 5-year survival rate of 98%–99%. These patients could potentially be treated with thermal ablation to avoid surgical excision, reduce treatment-related morbidity and increase patients’ quality of life without jeopardising treatment effectiveness. Previous studies showed highest complete ablation rates for radiofrequency, microwave and cryoablation. However, due to heterogeneity among studies, it is unknown which of these three techniques should be selected for a phase 3 comparative study.
The aim of this phase 2 screening trial is to determine the efficacy rate of radiofrequency, microwave and cryoablation with the intention to select one treatment for further testing in a phase 3 trial. Additionally, exploratory data are obtained for the phase 3 trial. The design is a multicentre open-label randomised phase 2 screening trial. Patients with unifocal, invasive breast cancer with a maximum diameter of 2 cm without lymph node or distant metastases are included. Triple negative, Bloom-Richardson grade 3 tumours and patients with an indication for neoadjuvant chemotherapy will be excluded. Included patients will be allocated to receive one of the three thermal ablation techniques. Three months later surgical excision will be performed to determine the efficacy of thermal ablation. Treatment efficacy in terms of complete ablation rate will be assessed with CK 8/18 and H&E staining. Secondary outcomes include feasibility of the techniques in an outpatient setting, accuracy of MRI for complete ablation, patient satisfaction, adverse events, side effects, cosmetic outcome, system usability and immune response.
This study protocol was approved by Medical Research Ethics Committee of the Erasmus Medical Center, Rotterdam, the Netherlands. Study results will be submitted for publication in peer-reviewed journals.
NL9205 (www.trialregister.nl); Pre-results.
Early phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures—this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.
This is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).
Ethics approval was granted by the National Health Service Health Research Authority on 15 June 2020—IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.