ResearchPad - 1717 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Psychometric properties of self-reported financial toxicity measures in cancer survivors: a systematic review protocol using COSMIN methodology]]> https://www.researchpad.co/article/elastic_article_12548 Due to the higher costs associated with advancements in cancer treatment and longer duration of cancer survivorship, increasing financial toxicity has become a great threat to survivors, caregivers and public healthcare systems. Since accurate and reproducible measures are prerequisites for robust results, choosing an acceptable measure with strong psychometric properties to assess financial toxicity is essential. However, a description of the psychometric properties of existing measures is still lacking. The aim of this study is to apply COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology to systematically review the content and structural validity of patient-reported outcome measures (PROMs) of financial toxicity for cancer survivors.Methods and analysisPubMed/Medline, Medline (Ovid), Embase (Ovid), CINAHL (EBSCO), Web of Science, ProQuest Dissertations and Theses, and Cochrane Library (Wiley) will be comprehensively searched from database inception to 15 November 2019. Studies that report the measurement properties of PROMs assessing financial toxicity for cancer survivors will be included. The evaluation of measurement properties, data extraction and data synthesis will be conducted according to the COSMIN methodology.Ethics and disseminationNo individual data are involved in this systematic review. The results will be disseminated to a clinical audience and policy-makers though peer-reviewed journals and conferences and will support researchers in choosing the best measure to evaluate the financial toxicity of cancer survivors. ]]> <![CDATA[Effect of time interval from diagnosis to treatment for non-small cell lung cancer on survival: a national cohort study in Taiwan]]> https://www.researchpad.co/article/N9dee4295-8e1a-4439-a015-ebcb38ac2aff This study aimed to determine if treatment delay after non-small cell lung cancer (NSCLC) diagnosis impacts patient survival rate.Study designThis study is a natural experiment in Taiwan. A retrospective cohort investigation was conducted from 2004 to 2010, which included 42 962 patients with newly diagnosed NSCLC.MethodsWe identified 42 962 patients with newly diagnosed NSCLC in the Taiwan Cancer Registry from 2004 to 2010. We calculated the time interval between diagnosis and treatment initiation. All patients were followed from the index date to death or the end of 2012. Cox proportional hazard models were used to examine the relationship between mortality and time interval.ResultsWe included 42 962 patients (15 799 men and 27 163 women) with newly diagnosed NSCLC. The mortality rate exhibited a significantly positive correlation to time interval from cancer diagnosis to treatment initiation. The adjusted HRs ranged from 1.04 to 1.08 in all subgroups time interval more than 7 days compared with the counterpart subgroup of the interval from cancer diagnosis to treatment ≤7 days. The trend was also noted regardless of the patients with lung cancer in stage I, stage II and stage III.ConclusionsThere is a major association between time to treat and mortality of patients with NSCLC, especially in stages I and II. We suggest that efforts should be made to minimise the interval from diagnosis to treatment while further study is ongoing to determine causation. ]]> <![CDATA[Clinicians’ attitudes to oncology clinical practice guidelines and the barriers and facilitators to adherence: a mixed methods study protocol]]> https://www.researchpad.co/article/Naf30d3e5-7ae9-4e6b-8c67-0ae595da6ef5

Introduction

Clinical practice guidelines (CPGs) are designed to reduce inappropriate clinical variation and improve the quality of care. Barriers to CPGs include a lack of awareness of CPGs, access to them, time pressures and concerns regarding the evidence underpinning CPG development, implementation and dissemination. The objectives of this study are to assess clinicians’ attitudes to CPGs for cancer treatment and the perceived barriers to and facilitators of CPG adherence in order to inform the implementation of cancer treatment CPGs.

Methods and analysis

A mixed methods study will be conducted using a three-phase, sequential design, with each phase informing the next. In phase 1, a qualitative study using recorded interviews will investigate clinicians’ attitudes to CPGs for cancer treatment and perceptions of barriers and facilitators to CPG adherence (n=30); interview transcripts will be analysed thematically. In phase 2, a survey will quantify the frequency of attitudes, barriers and facilitators identified in phase 1, in a broader clinical sample (n=200). In phase 3, a workshop forum will be held to facilitate discussions examining the implications of phase 1 and 2 findings for cancer CPG implementation strategies (n=40) leading to recommendations for improvements to practice. The workshop discussion will be recorded, and the transcript will be analysed thematically.

Ethics and dissemination

This study has received ethics approval in New South Wales, Australia (2019/ETH11722, #52019568810127). Study findings will be published in peer-reviewed journals and will form part of a doctoral thesis and be presented at national and international conferences.

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<![CDATA[Unmet needs and opportunities for improving care for patients with advanced lung cancer on targeted therapies: a qualitative study]]> https://www.researchpad.co/article/N06445fa0-0636-4dfd-a00a-01bbee8de32d

Objective

Lung cancer is increasingly recognised as a heterogeneous disease. Recent advances with targeted therapies for lung cancer with oncogenic mutations have greatly improved the prognosis for this subset of patients, yet little is known about their experiences. This study aimed to identify the needs and explore the healthcare experiences of these advanced patients with oncogenic mutation driven lung cancer.

Design

Qualitative interviews with patients with advanced or metastatic non-small cell lung cancer with oncogenic alterations in anaplastic lymphoma kinase, epidermal growth factor receptor or c-ros oncogene 1.

Settings

Patients were recruited from online lung cancer support groups within the USA. Interviews were conducted remotely or in person, transcribed verbatim and analysed using an iterative inductive and deductive process.

Participants

We included 39 patients (11 males and 28 females) with a median age of 48.

Results

Two primary theme categories emerged: patients' unmet needs and improving healthcare experiences. Unmet needs are related to patients’ desire to view their disease as a chronic illness, aspire to live a meaningful existence without financial devastation, desire for understanding along with emotional support and needing help with practical matters. Improving healthcare experiences involved patients’ desire to trust the expertise of clinical providers, receive reliable care and be treated holistically and as informed partners.

Conclusions

Patients with lung cancer with oncogenic mutations live uncharted experiences. Targeted therapy brings hope, but uncertainty is daunting. Patients grapple with the meaning and purpose of their lives while day-to-day obligations remain challenging. Healthcare teams are instrumental in their care experiences, and patients desire providers who are up-to-date on advances in the field and treat them as whole persons.

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<![CDATA[Phase I trial of WEE1 inhibition with chemotherapy and radiotherapy as adjuvant treatment, and a window of opportunity trial with cisplatin in patients with head and neck cancer: the WISTERIA trial protocol]]> https://www.researchpad.co/article/N014125dd-4509-4f1d-8f81-a25da4d15087

Introduction

Patients with head and neck squamous cell carcinoma with locally advanced disease often require multimodality treatment with surgery, radiotherapy and/or chemotherapy. Adjuvant radiotherapy with concurrent chemotherapy is offered to patients with high-risk pathological features postsurgery. While cure rates are improved, overall survival remains suboptimal and treatment has a significant negative impact on quality of life.

Cell cycle checkpoint kinase inhibition is a promising method to selectively potentiate the therapeutic effects of chemoradiation. Our hypothesis is that combining chemoradiation with a WEE1 inhibitor will affect the biological response to DNA damage caused by cisplatin and radiation, thereby enhancing clinical outcomes, without increased toxicity. This trial explores the associated effect of WEE1 kinase inhibitor adavosertib (AZD1775).

Methods and analysis

This phase I dose-finding, open-label, multicentre trial aims to determine the highest safe dose of AZD1775 in combination with cisplatin chemotherapy preoperatively (group A) as a window of opportunity trial, and in combination with postoperative cisplatin-based chemoradiation (group B).

Modified time-to-event continual reassessment method will determine the recommended dose, recruiting up to 21 patients per group. Primary outcomes are recommended doses with predefined target dose-limiting toxicity probabilities of 25% monitored up to 42 days (group A), and 30% monitored up to 12 weeks (group B). Secondary outcomes are disease-free survival times (groups A and B). Exploratory objectives are evaluation of pharmacodynamic (PD) effects, identification and correlation of potential biomarkers with PD markers of DNA damage, determine rate of resection status and surgical complications for group A; and quality of life in group B.

Ethics and dissemination

Research Ethics Committee, Edgbaston, West Midlands (REC reference 16/WM/0501) initial approval received on 18/01/2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences.

Trial registration number

ISRCTN76291951 and NCT03028766.

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<![CDATA[Returning to daily life: a qualitative interview study on parents of childhood cancer survivors in Germany]]> https://www.researchpad.co/article/N6ea4ea53-3d76-4782-a850-805d5aaa7a4d

Objectives

To investigate experiences of parents of paediatric cancer survivors in cancer-related changes in the parents’ daily life (work life, family life, partner relationship and social life) during and after intensive cancer treatment and to examine the reintegration process with its impeding and facilitating factors.

Design

The design of this cross-sectional study involves a qualitative content analysis of semistructured interviews.

Setting

Participants were consecutively recruited in clinical settings throughout Germany.

Participants

Forty-nine parents (59% female) of 31 cancer survivors (aged 0–17 at diagnosis of leukaemia or central nervous system tumour) were interviewed approximately 16–24 months after the end of intensive cancer treatment (eg, chemotherapy).

Results

During treatment, more than 70% of parents reported difficulties reconciling paid work, household and family responsibilities and caring for the ill child. Couples spent little time with each other and approximately 25% reported dispute and burden. Many parents did not have enough energy for pursuing any hobbies during treatment. However, over the long term, being faced with the child’s disease also led to strengthened relationships, new priorities, improved communication, increased mutual trust and greater appreciation for daily life. Supportive social networks (family/friends/employers), a strong partner relationship prior to the diagnosis and the use of psychosocial services (eg, family-oriented rehabilitation) had a positive impact. At the time of the interview, most families had adapted well. However, reintegration took time and some parents lacked the energy required to continue life as they did before the diagnosis.

Conclusions

Even though most parents successfully readjusted to a new ‘normality’, reintegrating into daily life after paediatric cancer treatment remains difficult. Professional psychosocial support could help families with the reintegration process. Lastly, clinical staff (eg, physicians, psychologists, social workers) should bear in mind that the burden of parents does not automatically end with the end of intensive cancer treatment.

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<![CDATA[A qualitative approach in determining the patient-centered information and supportive care needs of cancer patients in Singapore]]> https://www.researchpad.co/article/N74697b05-e280-4b1f-9361-c9b5436703ab

Objectives

To qualitatively interpret the information and supportive care needs perceived by cancer patients undergoing treatment in order to get a deeper appreciation of patients’ needs and concerns. The intended outcome is to provide baseline knowledge for improving patient-centred strategies to better meet the information and supportive needs of patients.

Design

A qualitative research approach, based on conventional content analysis, was used throughout the research process. The three open-ended questions obtained from a previous quantitative study guided the researchers to explore the information and supportive care needs of patients. Data from patients’ responses were analysed and coded in themes.

Participants and setting

Patients attending the Ambulatory Treatment Unit of the National Cancer Centre Singapore were invited to participate in the study. We determined from these subjects the type of information that cancer patients need, and to measure the extent to which these information needs are met by measuring patients’ level of satisfaction. Included in the quantitative study were three open-ended questions designed to gain a deeper understanding of their needs and concerns. All subjects were aged 21 years and above and able to understand and communicate in English/Mandarin. They were also aware of their diagnosis, they were not cognitively impaired and were not at the end-of-life situation.

Results

A variety of information and supportive care needs were identified, and three specific areas of concerns were identified: (1) psychosocial and supportive care needs, (2) information needs and (3) information delivery by professionals.

Conclusion

The information and supportive care needs expressed were consistent with issues of cancer patients undergoing treatment. The strategies to improve patients’ coping abilities through patient-centred care are discussed. Further studies assessing the barriers of information provision by healthcare professionals should provide more detailed knowledge about unmet information needs.

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<![CDATA[i-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol]]> https://www.researchpad.co/article/Nfc327f0b-9a2f-414e-815a-57efc079be72

Introduction

There is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third of patients. The safety and efficacy of exercise in counteracting treatment-related fatigue in patients with advanced melanoma receiving immunotherapy are yet to be determined. This study aims to assess the safety, adherence to and acceptability of a mixed-methods parallel-group, pilot randomised controlled trial of a personalised, 12-week semi-supervised exercise programme prescribed by an exercise physiologist (iMove) in 30 patients with stage IV melanoma scheduled to commence immunotherapy: single agent ipilimumab, nivolumab or pembrolizumab, or combination ipilimumab and nivolumab. The trial will be used to provide preliminary evidence of the potential efficacy of exercise for managing fatigue.

Methods and analysis

Thirty participants will be recruited from a specialist cancer centre between May and September, 2019. Participants will be randomised 1:1 to receive iMove, or usual care (an information booklet about exercise for people with cancer). Feasibility data comprise: eligibility; recruitment and retention rates; adherence to and acceptability of exercise consultations, personalised exercise programme and study measures; and exercise-related adverse events. Patient-reported outcome measures assess potential impact of the exercise intervention on: fatigue, role functioning, symptoms and quality of life. Follow-up will comprise five time points over 24 weeks. Physical assessments measure physical fitness and functioning.

Ethics and dissemination

This study was reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/48927/PMCC-2019). The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with clinicians, media, government and consumers. In particular, we will promote the outcomes of this work among the oncology community should this pilot indicate benefit for patients.

Trial registration number

ACTRN12619000952145; Pre-results.

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<![CDATA[Study protocol for a multisite randomised controlled trial of a rehabilitation intervention to reduce participation restrictions among female breast cancer survivors]]> https://www.researchpad.co/article/N5ab2d9e0-a441-4b3c-8000-b0b99cb380a6

Introduction

Many breast cancer survivors report an inability to fully participate in activities of daily living after completing cancer treatment. Reduced activity participation is linked to negative consequences for individuals (eg, depression, reduced quality of life) and society (reduced workforce participation). There is currently a lack of evidence-based interventions that directly foster cancer survivors’ optimal participation in life roles and activities. Pilot study data suggest rehabilitation interventions based on behavioural activation (BA) and problem-solving treatment (PST) can facilitate post-treatment role resumption among breast cancer survivors.

Methods and analysis

This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors’ activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1–3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later.

Ethics and dissemination

Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals.

Trial registration number

NCT03915548; Pre-results.

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<![CDATA[Scoping review protocol documenting cancer outcomes and inequalities for adults living with intellectual and/or developmental disabilities]]> https://www.researchpad.co/article/N3962e204-cae4-4b65-9e81-bcfc2ff1d24a

Introduction

There is increasing attention on the cancer burden for adults with intellectual and developmental disabilities (IDD). Emerging evidence suggests there are differences in cancer experiences and outcomes for individuals living with IDD, from risk through survivorship. These differences may be attributed to features of the IDD, such as cognitive deficits and communication, as well as social determinants of health-like lower education levels and ableism. However, there is no comprehensive overview of the literature quantifying these potential disparities and describing the influencing factors. In this paper, we describe a scoping review protocol to systematically review published literature on cancer for adults with IDD. The purpose of this review is to identify differences in cancer risk, stage at diagnosis, treatment and survival along the cancer continuum for adults with IDD and outline potential contributing factors creating these disparities.

Methods and analysis

We will follow Arksey and O’Malley’s expanded framework for scoping reviews to conduct this review. We will systematically search electronic databases for peer-reviewed, published journal articles to identify appropriate studies in collaboration with a health science librarian. Two reviewers will independently review titles and abstracts followed by a full-text review to determine whether it meets inclusion criteria. A data chart for collecting and sorting information will be developed in consultation with the team. Results will be collated and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews: PRISMA-Scoping Reviews. Extracted information will be summarised quantitatively and qualitatively to meet review objectives.

Ethics and dissemination

This scoping review will employ a methodology to identify literature related to cancer outcomes and experiences for adults with IDD. Results will be disseminated to relevant stakeholders who care for and support individuals with IDD at local, provincial and national levels and through publishing findings. By highlighting the disparities in the cancer system and gaps in the research, this scoping review can provide direction for future action.

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<![CDATA[Time intervals experienced between first symptom recognition and pathologic diagnosis of breast cancer in Addis Ababa, Ethiopia: a cross-sectional study]]> https://www.researchpad.co/article/N155d7519-b730-40bd-b77b-7591d13ee90d

Objectives

This study aimed to estimate the magnitude of patient and diagnostic delays and associated factors among women with breast cancer in Addis Ababa.

Design

This is a cross-sectional study.

Settings and participants

All women newly diagnosed with breast cancer in seven major healthcare facilities in Addis Ababa (n=441) were included in the study.

Main outcomes and measures

Patient interval (time from recognition of first symptom to medical consultation) and diagnostic interval (time from first consultation to diagnosis). Patient intervals >90 days and diagnostic intervals >30 days were considered delays, and associated factors were determined using multivariable Poisson regressions with robust variance.

Results

Thirty-six percent (95% CI [31.1%, 40.3%]) of the patients had patient intervals of >90 days, and 69% (95% CI [64.6%, 73.3%]) of the patients had diagnostic intervals of >30 days. Diagnostic interval exceeded 1 year for 18% of patients. Ninety-five percent of the patients detected the first symptoms of breast cancer by themselves, with breast lump (78.0%) as the most common first symptom. Only 8.0% were concerned about cancer initially, with most attributing their symptoms to other factors. In the multivariable analysis, using traditional medicine before consultation was significantly associated with increased prevalence of patient delay (adjusted prevalence ratio (PR) = 2.13, 95% CI [1.68, 2.71]). First consultation at health centres (adjusted PR = 1.19, 95% CI [1.02, 1.39]) and visiting ≥4 facilities (adjusted PR = 1.24, 95% CI [1.10, 1.40]) were associated with higher prevalence of diagnostic delay. However, progression of symptoms before consultation (adjusted PR = 0.73, 95% CI [0.60, 0.90]) was associated with decreased prevalence of diagnostic delay.

Conclusions

Patients with breast cancer in Addis Ababa have prolonged patient and diagnostic intervals. These underscore the need for public health programme to increase knowledge about breast cancer symptoms and the importance of early presentation and early diagnosis among the general public and healthcare providers.

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<![CDATA[Experiences and supportive care needs of UK patients with pancreatic cancer: a cross-sectional questionnaire survey]]> https://www.researchpad.co/article/Nbb5d0c46-eb7e-4330-b42b-6a3f3054c822

Objectives

Patients diagnosed with pancreatic cancer have the poorest survival prognosis of any cancer. This survey aimed to describe their experiences of care and supportive care needs to inform future service provision.

Design

Cross-sectional questionnaire survey of patients with pancreatic cancer in the UK.

Setting

Individuals at any stage along the care pathway were recruited via five National Health Service sites in the UK, and online, from January to June 2018.

Participants

274 individuals completed the questionnaire (78% (215) were completed online). Approximately half of participants were diagnosed within the last year (133/274). Of 212 providing gender details, 82 were male and 130 were female. Ninety per cent (192/213) described themselves as White British.

Primary outcome measures

Experiences of communication and information; involvement in treatment decisions; supportive care needs.

Results

Communication with, and care received from, clinical staff were generally reported positively. However, 29% (75/260) of respondents did not receive enough information at diagnosis, and 10% (25/253) felt they were not involved in decisions about their treatment, but would have liked to be. Supportive care needs were greatest in psychological and physical/daily living domains. 49% (108/221) of respondents reported one or more moderate/high unmet needs within the last month, of which the most commonly reported were: dealing with uncertainty about the future; fears about the cancer spreading; not being able to do things they used to; concerns about those close to them; lack of energy; anxiety; feelings of sadness and feeling down/depressed. Experiences were poorer, and unmet supportive care needs greater, in patients with unresectable disease.

Conclusions

Patients with pancreatic cancer have unmet information and support needs across the cancer trajectory. Psychological and physical support appears to be the biggest gap in care. Needs should be assessed and supportive care interventions implemented from the point of diagnosis, and monitored regularly to help patients live as good a quality of life as possible.

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<![CDATA[Impact of mobile applications on adherence to cancer treatment: a systematic review and meta-analysis protocol]]> https://www.researchpad.co/article/N58a31d1d-5b85-4d37-8f92-9f9c49d3bcec

Introduction

The number of patients taking oral chemotherapy is increasing around the world. It is essential to maximise the adherence to oral chemotherapy to improve the overall survival and life expectancy of the patients. In this systematic review and meta-analysis, we aim to evaluate the effectiveness of mobile applications in improving the adherence to oral chemotherapy and adjuvant hormonal therapy in cancer survivors.

Methods and analysis

MEDLINE, Embase, LILACS, clinicaltrials.gov, Scopus and the Cochrane Central Register of Controlled Trials will be searched for randomised or quasi-experimental studies published between January 2009 and July 2019. This systematic review and meta-analysis will include studies investigating the use of mobile applications by cancer survivors to aid adherence to oral chemotherapy and adjuvant hormonal therapy. Patient education, reminder tools, calendars, pillboxes and electronic reminders will not be evaluated. The primary outcome will be the improvement in adherence to anticancer drugs. The secondary outcomes will be an improvement in the overall survival and life expectancy, improved quality of life and control of cancer-related symptoms. Three independent reviewers will select the studies and extract data from the original publications. The risk-of-bias will be assessed using the Cochrane risk-of-bias tool. Data synthesis will be performed using the Review Manager software (RevMan V.5.2.3). To assess heterogeneity, we will compute the I2 statistics. Additionally, a quantitative synthesis will be performed if the included studies are sufficiently homogenous.

Ethics and dissemination

This study will be a review of the published data, and thus, ethical approval is not required. Findings of this systematic review will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42018102172.

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<![CDATA[Does multidisciplinary videoconferencing between a head-and-neck cancer centre and its partner hospital add value to their patient care and decision-making? A mixed-method evaluation]]> https://www.researchpad.co/article/Nd91f39cc-cb62-455c-88ee-4aa8ff6d8340

Objectives

Given the difficulties in diagnosing and treating head-and-neck cancer, care is centralised in the Netherlands in eight head-and-neck cancer centres and six satellite regional hospitals as preferred partners. A requirement is that all patients of the partner should be discussed in a multidisciplinary team meeting (MDT) with the head-and-neck centre as part of a Dutch health policy rule. In this mixed-method study, we evaluate the value that the video-conferenced MDT adds to the MDTs in the care pathway, quantitative regarding recommendations given and qualitative in terms of benefits for the teams and the patient.

Design

A sequential mixed-method study.

Setting

One oncology centre and its partner in the Northern part of the Netherlands.

Participants

Head-and-neck cancer specialists presenting patient cases during video-conferenced MDT over a period of 6 months. Semistructured interviews held with six medical specialists, three from the centre and three from the partner.

Primary and secondary outcome measures

Percentage of cases in which recommendations were given on diagnostic and/or therapeutic plans during video-conferenced MDT.

Results

In eight of the 336 patient cases presented (2%), specialists offered recommendations to the collaborating team (three given from centre to partner and five from partner to centre). Recommendations mainly consisted of alternative diagnostic modalities or treatment plans for a specific patient. Interviews revealed that specialists perceive added value in discussing complex cases because the other team offered a fresh perspective by hearing the case ‘as new’. The teams recognise the importance of keeping their medical viewpoints aligned, but the requirement (that the partner should discuss all patients) was seen as outdated.

Conclusions

The added value of the video-conferenced MDT is small considering patient care, but the specialists recognised that it is important to keep their medical viewpoints aligned and that their patients benefit from the discussions on complex cases.

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<![CDATA[[18F]DCFPyL PET-MRI/CT for unveiling a molecularly defined oligorecurrent prostate cancer state amenable for curative-intent ablative therapy: study protocol for a phase II trial]]> https://www.researchpad.co/article/Nf74a734e-b742-4c1f-bc85-9c8237597c1d

Introduction

The oligometastatic (OM) disease hypothesis of an intermediate metastatic state with limited distant disease deposits amenable for curative therapies remains debatable. Over a third of prostate cancer (PCa) patients treated with radical prostatectomy and postoperative radiotherapy experience disease recurrence; these patients are considered incurable by current standards. Often the recurrence cannot be localised by conventional imaging (CT and bone scan). Combined anatomical imaging with CT and/or MR with positron emission tomography (PET) using a novel second-generation prostate-specific membrane antigen (PSMA) probe, [18F]DCFPyL, is a promising imaging modality to unveil disease deposits in these patients. A new and earlier molecularly defined oligorecurrent (OR) state may be amenable to focal-targeted ablative curative-intent therapies, such as stereotactic ablative radiotherapy (SABR) or surgery, thereby significantly delaying or completely avoiding the need for palliative therapies in men with recurrent PCa after maximal local treatments.

Methods and analysis

This ongoing single-institution phase II study will enrol up to 75 patients total, to include up to 37 patients with response-evaluable disease, who have rising prostate-specific antigen (range 0.4–3.0 ng/mL) following maximal local therapies with no evidence of disease on conventional imaging. These patients will undergo [18F]DCFPyL PET-MR/CT imaging to detect disease deposits, which will then be treated with SABR or surgery. The primary endpoints are performance of [18F]DCFPyL PET-MR/CT, and treatment response rates following SABR or surgery. Demographics and disease characteristics will be summarised and analysed descriptively. Response rates will be described with waterfall plots and proportions.

Ethics and dissemination

Ethics approval was obtained from the institutional Research Ethics Board. All patients will provide written informed consent. [18F]DCFPyL has approval from Health Canada. The results of the study will be disseminated by the principal investigator. Patients will not be identifiable as individuals in any publication or presentation of this study.

Trial registration numbers

NCT03160794

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<![CDATA[Study protocol for an open-label, single-arm, multicentre phase II trial to evaluate the efficacy and safety of combined triplet therapy and olanzapine for prevention of carboplatin-induced nausea and vomiting in gynaecological cancer patients]]> https://www.researchpad.co/article/5c64469ad5eed0c484c2c0fc

Introduction

Carboplatin (CBDCA) administered at a dosage of 4 mg/mL/min or more area under the blood concentration-time curve (AUC) is considered to be ranked as the highest chemotherapy-induced nausea and vomiting (CINV) risk of the moderately emetogenic chemotherapy agents. The complete response (CR) rate for preventing overall CINV, defined as no emetic episodes and no use of rescue medication, for standard triplet antiemetic therapy (5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; NK1RA, neurokinin-1 receptor antagonist; DEX, dexamethasone) was approximately 60% in gynaecological cancer patients receiving CBDCA-based therapy. Further improvement in antiemetic treatment is needed to optimise care. This trial is to evaluate the efficacy and safety of using 5 mg olanzapine (OLZ) plus standard triplet antiemetic therapy for CINV after AUC ≥4 mg/mL/min CBDCA combination therapy in gynaecological cancer patients.

Methods and analysis

This trial is an open-label, single-arm, multicentre phase II trial. Patients who receive CBDCA (AUC ≥4)-based therapy and have never been administered moderate to high emetogenic chemotherapy will be enrolled. All patients will receive OLZ (5 mg oral administration on days 1–4, after supper) in combination with 5-HT3RA, NK1RA and DEX. The primary endpoint is the CR rate during the overall period (0–120 hours). Testing the hypothesis that this regimen can improve CR rate from 60% (null hypothesis) to 75% (alternative hypothesis) with a one-sided type I error of 0.1 and power of 0.8 will require 53 patients. Considering the dropout rate, the target sample size is set at 60.

Ethics and dissemination

The study protocol was approved by the institutional review board at each of the participating centres. Data will be presented at international conferences and published in peer-reviewed journals.

Trial registration number

UMIN000031646.

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<![CDATA[Efficacy of a dual-ring wound protector for prevention of incisional surgical site infection after Whipple's procedure (pancreaticoduodenectomy) with preoperatively-placed intrabiliary stents: protocol for a randomised controlled trial]]> https://www.researchpad.co/article/5ba6e51040307c489cbf7a20

Introduction

Among surgical oncology patients, incisional surgical site infection is associated with substantially increased morbidity, mortality and healthcare costs. Moreover, while adults undergoing pancreaticoduodenectomy with preoperative placement of an intrabiliary stent have a high risk of this type of infection, and wound protectors may significantly reduce its risk, no relevant studies of wound protectors yet exist involving this patient population. This study will evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among adults undergoing pancreaticoduodenectomy with preoperatively-placed intrabiliary stents.

Methods and analysis

This study will be a parallel, dual-arm, randomised controlled trial that will utilise a more explanatory than pragmatic attitude. All adults (≥18 years) undergoing a pancreaticoduodenectomy at the Foothills Medical Centre in Calgary, Alberta, Canada with preoperative placement of an intrabiliary stent will be considered eligible. Exclusion criteria will include patient age <18 years and those receiving long-term glucocorticoids. The trial will employ block randomisation to allocate patients to a commercial dual-ring wound protector (the Alexis Wound Protector) or no wound protector and the current standard of care. The main outcome measure will be the rate of surgical site infection as defined by the Centers for Disease Control and Prevention criteria within 30 days of the index operation date as determined by a research assistant blinded to treatment allocation. Outcomes will be analysed by a statistician blinded to allocation status by calculating risk ratios and 95% CIs and compared using Fisher's exact test.

Ethics and dissemination

This will be the first randomised trial to evaluate the efficacy of a dual-ring wound protector for prevention of incisional surgical site infection among patients undergoing pancreaticoduodenectomy. Results of this study are expected to be available in 2016/2017 and will be disseminated using an integrated and end-of-grant knowledge translation strategy.

Trial registration number

ClinicalTrials.gov identifier NCT01836237.

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<![CDATA[How does the process of group singing impact on people affected by cancer? A grounded theory study]]> https://www.researchpad.co/article/5c59e0f1d5eed0c484111406

Objective

This study aimed to build an understanding of how the process of singing impacts on those who are affected by cancer, including patients, staff, carers and those who have been bereaved.

Design

A qualitative study, informed by a grounded theory approach.

Setting and participants

Patients with cancer, staff, carers and bereaved who had participated for a minimum of 6 weeks in one of two choirs for people affected by cancer.

Methods

31 participants took part in Focus Group Interviews lasting between 45 min and an hour, and 1 participant had a face-to-face interview.

Findings

Four overarching themes emerged from the iterative analysis procedure. The overarching themes were: building resilience, social support, psychological dimensions and process issues. Following further analyses, a theoretical model was created to depict how building resilience underpins the findings.

Conclusion

Group singing may be a suitable intervention for building resilience in those affected by cancer via an interaction between the experience and impact of the choir.

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<![CDATA[Precision-Exercise-Prescription in patients with lung cancer undergoing surgery: rationale and design of the PEP study trial]]> https://www.researchpad.co/article/5c394647d5eed0c484a368a6

Introduction

Lung cancer is a significant burden on societies worldwide, and the most common cause of death in patients with cancer overall. Exercise intervention studies in patients with lung cancer have consistently shown benefits with respect to physical and emotional functioning. However, to date, exercise training has not been consistently implemented into clinical practice given that interventions have been costly and not aligned with clinical care.

Methods/design

The Precision-Exercise-Prescription (PEP) study is a prospective randomised controlled trial comparing the effectiveness and feasibility of a personalised intervention exercise programme among patients with lung cancer undergoing surgery. Two-hundred patients who are diagnosed with stage primary or secondary lung cancer and are eligible to undergo surgical treatment at Huntsman Cancer Institute comprise the target population. Patients are randomised to either the (1) outpatient precision-exercise intervention group or (2) delayed intervention group. The intervention approach uses Motivation and Problem Solving, a hybrid behavioural treatment based on motivational interviewing and practical problem solving. The dosage of the exercise intervention is personalised based on the individual’s Activity Measure for Post-Acute-Care outpatient basic mobility score, and incorporates four exercise modes: mobility, callisthenics, aerobic and resistance. Exercise is implemented by physical therapists at study visits from presurgery until 6 months postsurgery. The primary endpoint is the level of physical function assessed by 6 min walk distance at 2 months postsurgery. Secondary outcomes include patient-reported outcomes (eg, quality of life, fatigue and self-efficacy) and other clinical outcomes, including length of stay, complications, readmission, pulmonary function and treatment-related costs up to 6 months postsurgery.

Ethics/dissemination

The PEP study will test the clinical effectiveness and feasibility of a personalised exercise intervention in patients with lung cancer undergoing surgery. Outcomes of this clinical trial will be presented at national and international conferences and symposia and will be published in international, peer-reviewed journals. Ethics approval was obtained at the University of Utah (IRB 00104671).

Trial registration number

NCT03306992.

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<![CDATA[EduCan trial: study protocol for a randomised controlled trial on the effectiveness of pain neuroscience education after breast cancer surgery on pain, physical, emotional and work-related functioning]]> https://www.researchpad.co/article/5c59e0f5d5eed0c48411141e

Introduction

Over the past decades, awareness on the importance of educational interventions in cancer pain management has increased. However, education is often restricted to biomedical pain management instructions. A more modern educational approach, also known as pain neuroscience education (PNE), explains pain from a biopsychosocial perspective. We hypothesise that this more comprehensive educational approach in the early treatment phase of breast cancer will lead to more beneficial effects for cancer pain management. Therefore, the aim of the present study is to investigate the effectiveness of this PNE intervention, in addition to best evidence physical therapy modalities for treatment and prevention of pain, physical, emotional and work-related functioning after breast cancer surgery, compared with a traditional biomedical educational intervention.

Methods

A double-blinded randomised controlled trial has been started in November 2017 at the University Hospitals of Leuven. Immediately after breast cancer surgery, all participants (n=184) receive a 12-week intensive standard physical therapy programme. They receive three additional refresher sessions at 6, 8 and 12 months postsurgery. In addition, participants receive three educational sessions during the first-month postsurgery and three ‘booster sessions’ at 6, 8 and 12 months postsurgery. In the intervention group, the content of the education sessions is based on the modern PNE approach. Whereas in the control group, the education is based on the traditional biomedical approach. The primary outcome parameter is pain-related disability 1 year after surgery. Secondary outcomes related to other dimensions of pain, physical, emotional and work-related functioning at 1-week, 4, 6, 8, 12 and 18 months postsurgery.

Ethics and dissemination

The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the ethical committee of the University Hospitals of Leuven. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses.

Trial registration number

NCT03351075.

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