Clinical outcomes using a 3D printed tandem-needle-template and the EMBRACE-II planning aims for image guided adaptive brachytherapy in locally advanced cervical cancer.

BACKGROUND: Extensive local disease or narrow vagina may compromise brachytherapy (BT) in patients with cervical cancer. This is the first study to analyze long-term outcomes of using 3D printed vaginal tandem-needle templates (3DP TNT) for transvaginal insertion of needles in parallel (P) or parallel and oblique (P&O) direction to the tandem. MATERIAL AND METHODS: All patients treated with BT using 3DP TNT from 2015-2020 were included. Decision to use a 3DP TNT and preplanning were made after 4-5 weeks of external beam radiotherapy, based on gynecological examination and MRI with a tandem-ring applicator in situ. The TNT was 3D-printed in house consisting of a circular template with P&O holes for guidance of plastic needles and a shaft fitting the uterine tandem. Thus, the radioactive source was never in direct contact with the 3DP TNT. The TNT was 3D printed in a standard or personalized configuration. Planning aims were based on the Embrace II protocol. RESULTS: 101 patients (median age of 63 years) were included: 49 with P needles only and 52 with P&O needles. Personalized TNT was used in 19 patients in the P&O group. Performance status (WHO) was > 0 in 48%. FIGO2018 stage III-IV was present in 77%. T-score at diagnosis and BT was 9.1 and 6.3 respectively, with a significantly higher T-score in the P&O compared to P group. The mean high-risk CTV D90 was 93 Gy with no significant difference between the two groups. Three-year local control rates were 85%, 95%, 75% for the overall, P- and P&O group respectively and 68%, 80% and 56% for cancer specific survival. Grade ≥3 treatment related complications were observed in 10 (10%) patients. CONCLUSIONS: 3DP TNT for BT in cervical cancer provides successful management of very extensive local disease and/or unfavorable anatomy with the possibility for treatment individualization.

Development, implementation and evaluation of patient decision aids supporting shared decision making in women with recurrent ovarian cancer.

Objective: Shared decision making (SDM) and use of patient decision aids (PtDAs) are key components in patient-centered care in relapsed ovarian cancer. This paper describes the development and implementation process of PtDAs into a clinical routine in three departments. Methods: Two PtDAs were developed in collaboration between patients and clinicians. Acceptability and usability of the PtDAs were tested on clinicians and patients using items from the internationally validated questionnaire "Preparation for Decision Making Scale". Results: Ten patients and 15 clinicians participated in the study. Most patients indicated that PtDAs would be helpful as preparation for the decision-making process with the clinicians. Ten (75%) of the clinicians responded that the PtDAs helped the patients to understand the benefits and disadvantages of each treatment option. Generally, the clinicians indicated that they would use SDM if they had a PtDA tailored to the clinical situation. Conclusions: Two PtDAs were systematically developed, tested, and implemented thereby supporting an SDM intervention. The PtDAs are still in use at the participating departments. Innovation: This study was successful in reusing a generic template for a patient decision aid (PtDA) developed at one institution and implemented in two other institutions. This was guided by a well-described systematic development process for PtDAs.

Shared decision making in recurrent ovarian cancer: Implementation of patient decision aids across three departments of oncology in Denmark.

Objective: Patients with relapsed ovarian cancer are offered multiple treatment options. To match treatment with the individual patient's life situation and preferences, healthcare professionals can apply shared decision making (SDM) including patient decision aids (PtDAs).This study aimed to evaluate the implementation of two different PtDAs in consultations with patients suffering from relapsed ovarian cancer. Methods: We analyzed the following data before and after implementation of the PtDAs: 1) observed SDM using the OPTION instrument, 2) physician treatment recommendations, and 3) patients' and physicians' evaluations of SDM in consultations using the CollaboRATE, SDM-Q-9, and SDM-Q-Doc. Results: Significant improvement in observed SDM was found after the implementation (p = 0.002). Improvement of SDM was detected in consultations conducted by physicians reporting more than two hours of SDM-training (p < 0.001), but not when physicians reported less than two hours of SDM-training.No before/after differences in treatment recommendations and in patients' and physicians' evaluations were found. Conclusion: Implementation of PtDAs improved the level of observed SDM. Training of physicians in SDM is necessary for improved SDM practice. Innovation: Discussing oncological treatment options with the use of PtDAs is not standard practice in Denmark. The present study is one of the first Danish studies focusing on how to implement SDM and PtDAs in oncological consultations.

Olaparib treatment in older patients with ovarian cancer: need for 'real-world' data beyond clinical trials.

BACKGROUND: Ageing is a risk factor for cancer. Worldwide, the number and proportion of adults aged ≥65 will increase, along with the incidence of ovarian cancer. Older adults are under-represented in randomised clinical trials (RCTs), and those who are enrolled have a good performance status and no major health issues. These patients are not representative of older patients seen in everyday clinical practice; therefore, age-specific data on efficacy and toxicity of olaparib in the 'real-world' setting are lacking. METHODS: This observational study was conducted in the Central Jutland Region in Denmark. Data in unselected older (≥65) patients with known BRCA mutation receiving olaparib maintenance treatment for platinum-sensitive relapsed ovarian cancer were registered between 2015 and 2019. Toxicity and progression-free survival (PFS) were registered. No geriatric assessment has been performed. RESULTS: In total, 20 consecutive patients ≥65 years were included with a median age of 75 years (range: 65-85). Most of the patients (18/20) had ECOG PS: 0-1. Treatment interruption and dose reduction occurred in 65% of the patients. Toxicities of any grade occurred in 18 (90%), whereas grade 3/4 toxicities occurred in 6 patients (30%). Treatment was terminated due to disease progression or unacceptable toxicity in 13 (65%) patients. The median PFS was 6 months (range: 2-31), and the median follow-up was 15 months (range: 3-30). DISCUSSION: Our 'real-world' experience shows that unselected older patients represent a significant larger proportion in real life than in RCTs; furthermore, older patients in a real-world setting may experience more side effects possibly affecting the quality of life. The median PFS data suggest that older patients may not derive the same clinical benefit than their fit and younger counterparts.There is a need to enrol vulnerable/frail older patients into RCTs, ensuring that data will also be applicable in standard clinical settings. Incorporating geriatric assessment into these trials should be encouraged.

Negative cancer beliefs, recognition of cancer symptoms and anticipated time to help-seeking: an international cancer benchmarking partnership (ICBP) study.

BACKGROUND: Understanding what influences people to seek help can inform interventions to promote earlier diagnosis of cancer, and ultimately better cancer survival. We aimed to examine relationships between negative cancer beliefs, recognition of cancer symptoms and how long people think they would take to go to the doctor with possible cancer symptoms (anticipated patient intervals). METHODS: Telephone interviews of 20,814 individuals (50+) in the United Kingdom, Australia, Canada, Denmark, Norway and Sweden were carried out using the Awareness and Beliefs about Cancer Measure (ABC). ABC included items on cancer beliefs, recognition of cancer symptoms and anticipated time to help-seeking for cough and rectal bleeding. The anticipated time to help-seeking was dichotomised as over one month for persistent cough and over one week for rectal bleeding. RESULTS: Not recognising persistent cough/hoarseness and unexplained bleeding as cancer symptoms increased the likelihood of a longer anticipated patient interval for persistent cough (OR = 1.66; 95%CI = 1.47-1.87) and rectal bleeding (OR = 1.90; 95%CI = 1.58-2.30), respectively. Endorsing four or more out of six negative beliefs about cancer increased the likelihood of longer anticipated patient intervals for persistent cough and rectal bleeding (OR = 2.18; 95%CI = 1.71-2.78 and OR = 1.97; 95%CI = 1.51-2.57). Many negative beliefs about cancer moderated the relationship between not recognising unexplained bleeding as a cancer symptom and longer anticipated patient interval for rectal bleeding (p = 0.005). CONCLUSIONS: Intervention studies should address both negative beliefs about cancer and knowledge of symptoms to optimise the effect.

Patient evaluation of breast cancer follow-up: A Danish survey.

OBJECTIVE: The purpose of this study was to determine how age influences the degree to which patients with breast cancer feel comfortable with standard follow-up and to assess their satisfaction with the contact to health professionals. METHODS: Data was from a Danish population-based questionnaire survey from 2012 including adult cancer patients. 1120 patients with breast cancer returned the questionnaire (response rate: 73%). Age groups were decided before conducting analyses. RESULTS: Overall, patients with breast cancer evaluated the follow-up programme positively. However, in five of six items of interest, patients aged 40-49 and 50-59 years differed statistically significantly from patients ≥70 years, by being less comfortable with the follow-up, less satisfied with the health care professionals' ability to listen, and less satisfied with the health care professionals' answers. Satisfaction with the length of consultations, and the number of involved health care professionals were also lower in these age groups compared to patients ≥70 years. CONCLUSION: Overall, satisfaction with follow-up was high, but considerable age-related variations were found. PRACTICE IMPLICATIONS: The findings suggest a potential for improving the services provided for patients aged 40-59 years with breast cancer.

Measurement properties of the Danish version of the Awareness and Beliefs about Cancer (ABC) measure.

BACKGROUND: The International Cancer Benchmarking Partnership aims to study international differences in cancer survival and the possible causes. Participating countries are Australia, Canada, Norway, Sweden, Denmark and the UK and a particular focus area is differences in awareness and beliefs about cancer. In this connection, the Awareness and Beliefs about Cancer (ABC) measure has been translated into multiple languages. The aim of this study is to appraise the translation process and measurement properties of the Danish version of the ABC measure. METHODS: The translation process included forward and backward translations and a pilot-test. Data quality was assessed using survey data from 3000 Danish respondents and content validity indexes were calculated based on judgments from ten academic researchers. Construct validity was determined by a confirmative factor analysis (CFA) and exploratory factor analyses (EFA) using survey data and a known group comparison analysis including 56 persons. Test-retest reliability was assessed based on responses from 123 person whom completed the interview twice with an interval of 2-3 weeks. RESULTS: The translation process resulted in a Danish ABC measure conceptually equivalent to the English ABC measure. Data quality was acceptable in relation to non-response to individual items which was maximum 0.3%, but the percentage of respondents answering 'don't know' was above 3% for 16 out of 48 items. Content validity indexes showed that items adequately reflected and represented the constructs to be measured (item content validity indexes: 0.9-1.0; construct content validity indexes: 0.8-1.0). The hypothesised factor structure could not be replicated by a CFA, but EFA on each individual subscale showed that six out of seven subscales were unidimensional. The ABC measure discriminated well between non-medical academics and medical academics, but had some difficulties in discriminating between educational groups. Test-retest reliability was moderate to substantial for most items. CONCLUSIONS: The Danish ABC measure is a useful measurement that is accepted and understood by the target group and with accepted measurement criteria for content validity and test-retest reliability. Future studies may further explore the factorial structure of the ABC measure and should focus on improving the response categories.

Hypercalcemia in metastatic GIST caused by systemic elevated calcitriol: a case report and review of the literature.

BACKGROUND: Hypercalcemia is the most common oncologic metabolic emergency but very rarely observed in patients with gastrointestinal stromal tumour, which is a rare mesenchymal malignancy of the gastrointestinal tract. We describe a case of hypercalcemia caused by elevated levels of activated vitamin D in a patient with gastrointestinal tumour. Prior to this case report, only one paper has reported an association between hypercalcemia, gastrointestinal stromal tumours and elevated levels of vitamin D. CASE PRESENTATION: An otherwise healthy 70-year-old Caucasian woman, previously treated for duodenal gastrointestinal stromal tumour, was diagnosed with liver metastasis, and relapse of gastrointestinal stromal tumour was confirmed by biopsy. At presentation, the patient suffered from severe symptoms of hypercalcemia. The most common causes of hypercalcemia, hyperparathyrodism, parathyroid hormone-related peptide secretion from tumour cells, and metastatic bone disease, were all dismissed as the etiology. Analysis of vitamin D subtypes revealed normal levels of both 25-OH Vitamin D2 and 25-OH Vitamin D3, whereas the level of activated vitamin D, 1,25 OH Vitamin D3, also referred to as calcitriol, was elevated. CONCLUSION: The fact that plasma calcitriol decreased after initiation of oncological treatment and the finding that hypercalcemia did not recur during treatment support the conclusion that elevated calcitriol was a consequence of the gastrointestinal stromal tumour. We suggest that gastrointestinal stromal tumours should be added to the list of causes of humoral hypercalcemia in malignancy, and propose that gastrointestinal stromal tumour tissue may have high activity of the specific enzyme 1α-hydroxylase, which can lead to increased levels of calcitriol and secondarily hypercalcemia.

Barriers to healthcare seeking, beliefs about cancer and the role of socio-economic position. A Danish population-based study.

BACKGROUND: Cancer-related health behaviours may be affected by barriers to healthcare seeking and beliefs about cancer. The aim was to assess anticipated barriers to healthcare seeking and beliefs about cancer in a sample of the Danish population and to assess the association with socio-economic position. METHODS: A population-based telephone interview with 3000 randomly sampled persons aged 30 years or older was performed using the Awareness and Beliefs about Cancer measure from 31 May to 4 July 2011. The Awareness and Beliefs about Cancer measure includes statements about four anticipated barriers to healthcare seeking and three positively and three negatively framed beliefs about cancer. For all persons, register-based information on socio-economic position was obtained through Statistics Denmark. RESULTS: Two anticipated barriers, worry about what the doctor might find and worry about wasting the doctor's time, were present among 27% and 15% of the respondents, respectively. Overall, a high proportion of respondents concurred with positive beliefs about cancer; fewer concurred with negative beliefs. Having a low educational level and a low household income were strongly associated with having negative beliefs about cancer. CONCLUSION: The fact that worry about what the doctor might find and worry about wasting the doctor's time were commonly reported barriers call for initiatives in general practice. The association between low educational level and low household income and negative beliefs about cancer might to some degree explain the negative socio-economic gradient in cancer outcome.

Cancer awareness and socio-economic position: results from a population-based study in Denmark.

BACKGROUND: Differences in cancer awareness between individuals may explain variations in healthcare seeking behaviour and ultimately also variations in cancer survival. It is therefore important to examine cancer awareness and to investigate possible differences in cancer awareness among specific population subgroups. The aim of this study is to assess awareness of cancer symptoms, risk factors and perceived 5-year survival from bowel, breast, ovarian, and lung cancer in a Danish population sample and to analyse the association between these factors and socio-economic position indicators. METHODS: A population-based telephone survey was carried out among 1,000 respondents aged 30-49 years and 2,000 respondents aged 50 years and older using the Awareness and Beliefs about Cancer measure. Information on socio-economic position was obtained by data linkage through Statistics Denmark. Prevalence ratios were used to determine the association between socio-economic position and cancer awareness. RESULTS: A strong socio-economic gradient in cancer awareness was found. People with a low educational level and a low household income were more likely to have a lower awareness of cancer symptoms, cancer risk factors and the growing risk of cancer with age. Furthermore, men and people outside the labour force tended to be less aware of these factors than women and people within the labour force. However, women were more likely than men to lack awareness of the relationship between age and cancer risk. No clear associations were found between socio-economic position and lack of awareness of 5-year survival from bowel, breast, ovarian, and lung cancers. CONCLUSIONS: As cancer awareness has shown to be positively associated with cancer-related behaviour, e.g. healthcare seeking, consideration must be given to tackle inequalities in cancer awareness and to address this issue in future public health strategies, which should be targeted at and tailored to the intended recipient groups.

A survey of cancer patients' unmet information and coordination needs in handovers--a cross-sectional study.

BACKGROUND: The care responsibilities for cancer patients are frequently handed over from one healthcare professional to another. These handovers are known to pose a threat to the safety of patients and the efficiency of the healthcare system. Little is known about specific needs of cancer patients in handovers. The objectives of this study were to examine cancer patients' unmet needs for information and coordination in handovers and to analyse the association between patients' demographic and clinical characteristics and unmet information and coordination needs. METHODS: Cancer patients treated in an oncology and a surgery outpatient setting completed a questionnaire developed to examine unmet information and coordination needs of cancer patients in handovers. Associations between unmet needs and comorbidity, treatment type, time since diagnosis, gender, age, and education in various handover situations were analysed. RESULTS: Of 250 eligible patients 131 participated (response rate of 52%). Overall, 18% of patients had unmet coordination needs and 18% had unmet information needs.Hospital discharge was the type of handover where patients most frequently reported unmet information needs (18%). Unmet coordination needs were most frequently reported in handovers between different hospitals (19%) and in handovers between hospital and general practice (18%). In general, age and education were statistically significantly associated with reporting unmet needs, where patients younger than 60 years and patients with a higher education were more likely to express unmet needs. CONCLUSIONS: The findings indicate room for improvements regarding exchange of information and coordination between healthcare professionals, and between healthcare professionals and patients.

A randomised controlled trial of hospital-based case management to improve colorectal cancer patients' health-related quality of life and evaluations of care.

OBJECTIVE: To analyse the effectiveness of hospital-based case management (CM) in terms of patient-reported outcomes. DESIGN: Randomised controlled trial allocating participants 1 : 1 to either a CM intervention or a control group. Allocation status was evident to participants and case managers, but blinded to researchers. SETTING: Patients were recruited at a Danish surgical department where the case managers were situated. PARTICIPANTS: Colorectal cancer patients who were to undergo further investigation or treatment. Exclusion criteria were participation in another study, poor Danish language skills or apparent cognitive impairment. 140 participants were randomised to each group. Recruitment period was 11 March 2009 to 29 December 2010. INTERVENTIONS: Control group patients had usual care. Intervention group patients had usual care supplemented by hospital-based CM started at first visit to the out-patient clinic (before treatment start) and ended 4 weeks after completed cancer treatment. CM was conducted by nurse case managers who undertook care pathway supervision, information dissemination to health professionals and outreaching patient support. OUTCOME MEASURES: Patient-reported global quality of life measured with the EORTC QLQ-C30 and eight ad hoc, piloted patient evaluation items assessed at eight, 30 and 52 weeks after randomisation. RESULTS: The two groups were comparable as to questionnaire response rates and completed scales/items. There were no statistically significant group differences on any of the health-related quality of life subscales at eight, 30 or 52 weeks. In patient evaluations, all point estimates favoured CM at week 8 and 30; at week 52, 6 of 7 estimates favoured CM. CONCLUSIONS: We found no evidence that CM influenced colorectal cancer patients' health-related quality of life. Patients allocated to CM evaluated their care more positively than patients receiving usual care. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00845247.

[People's cancer awareness and beliefs]. / Befolkningens viden og forestillinger om kræft.

Lack of awareness of cancer symptoms, cancer risk factors, and erroneous beliefs about cancer may influence delay in presentation of cancer symptoms and thereby treatment outcomes. This paper refers cancer awareness population studies (mainly from the UK) and describes associations between elements of the Health Belief Model and cancer-related health behavior. Denmark is part of the International Cancer Benchmarking Partnership which, inter alia, will examine whether differences in cancer survival across countries can be explained by different levels of cancer awareness and erroneous beliefs about cancer.