Participants' experiences of the management of screen-detected complex polyps within a structured bowel cancer screening programme.

BACKGROUND: The Bowel Screening Wales complex polyp removal service was introduced to address variations in surgery rates for screen-detected complex benign colorectal polyps, to improve the quality of the screening service and to make management of these polyps more equitable across Wales. Little is known about patient experiences and the potential impact on quality of life when undergoing complex polyp removal. This study is part of a wider research programme evaluating the decision-making, pathways and outcomes from complex polyp removal. OBJECTIVE: This study aimed to understand experiences of having a complex polyp removed and how this may influence quality of life. DESIGN: Semi-structured telephone interviews were conducted, and a thematic approach was used for data analysis. SETTING AND PARTICIPANTS: All participants had a complex polyp removed after a positive stool test and review by Bowel Screening Wales' Network Multi-Disciplinary Team. RESULTS: Twenty-one participants were interviewed. Most participants had their complex polyps removed endoscopically and reported no or minor problems or negative outcomes following their procedure. For a small minority, worse problems (e.g., pain, bowel dysfunction) and negative outcomes (e.g., cancer) followed their procedures. Most participants felt supported and reassured throughout their procedures. Any physical and emotional changes to quality of life were mainly linked to procedure outcomes. DISCUSSION: Experiences of complex polyp removal were generally positive, with minimal changes in quality of life. CONCLUSIONS: While most people had a positive experience of having a complex polyp removed, support initiatives, such as counselling or signposting to coping strategies, may be helpful to reduce any potential negative effects of procedures on quality of life. PATIENT OR PUBLIC CONTRIBUTION: Four patient and public involvement partners provided feedback on participant materials.

Bridging The Age Gap: observational cohort study of effects of chemotherapy and trastuzumab on recurrence, survival and quality of life in older women with early breast cancer.

BACKGROUND: Chemotherapy improves outcomes for high risk early breast cancer (EBC) patients but is infrequently offered to older individuals. This study determined if there are fit older patients with high-risk disease who may benefit from chemotherapy. METHODS: A multicentre, prospective, observational study was performed to determine chemotherapy (±trastuzumab) usage and survival and quality-of-life outcomes in EBC patients aged ≥70 years. Propensity score-matching adjusted for variation in baseline age, fitness and tumour stage. RESULTS: Three thousands four hundred sixteen women were recruited from 56 UK centres between 2013 and 2018. Two thousands eight hundred eleven (82%) had surgery. 1520/2811 (54%) had high-risk EBC and 2059/2811 (73%) were fit. Chemotherapy was given to 306/1100 (27.8%) fit patients with high-risk EBC. Unmatched comparison of chemotherapy versus no chemotherapy demonstrated reduced metastatic recurrence risk in high-risk patients(hazard ratio [HR] 0.36 [95% CI 0.19-0.68]) and in 541 age, stage and fitness-matched patients(adjusted HR 0.43 [95% CI 0.20-0.92]) but no benefit to overall survival (OS) or breast cancer-specific survival (BCSS) in either group. Chemotherapy improved survival in women with oestrogen receptor (ER)-negative cancer (OS: HR 0.20 [95% CI 0.08-0.49];BCSS: HR 0.12 [95% CI 0.03-0.44]).Transient negative quality-of-life impacts were observed. CONCLUSIONS: Chemotherapy was associated with reduced risk of metastatic recurrence, but survival benefits were only seen in patients with ER-negative cancer. Quality-of-life impacts were significant but transient. TRIAL REGISTRATION: ISRCTN 46099296.

Development and user-testing of a brief decision aid for aspirin as a preventive approach alongside colorectal cancer screening.

BACKGROUND: Several epidemiological and cohort studies suggest that regular low-dose aspirin use independently reduces the long-term incidence and risk of colorectal cancer deaths by approximately 20%. However, there are also risks to aspirin use, mainly gastrointestinal bleeding and haemorrhagic stroke. Making informed decisions depends on the ability to understand and weigh up benefits and risks of available options. A decision aid to support people to consider aspirin therapy alongside participation in the NHS bowel cancer screening programme may have an additional impact on colorectal cancer prevention. This study aims to develop and user-test a brief decision aid about aspirin to enable informed decision-making for colorectal screening-eligible members of the public. METHODS: We undertook a qualitative study to develop an aspirin decision aid leaflet to support bowel screening responders in deciding whether to take aspirin to reduce their risk of colorectal cancer. The iterative development process involved two focus groups with public members aged 60-74 years (n = 14) and interviews with clinicians (n = 10). Interviews (n = 11) were used to evaluate its utility for decision-making. Analysis was conducted using a framework approach. RESULTS: Overall, participants found the decision aid acceptable and useful to facilitate decision-making. They expressed a need for individualised risk information, more detail about the potential risks of aspirin, and preferred risk information presented in pictograms when offered different options. Implementation pathways were discussed, including the possibility of involving different clinicians in the process such as GPs and/or community pharmacists. A range of potentially effective timepoints for sending out the decision aid were identified. CONCLUSION: An acceptable and usable decision aid was developed to support decisions about aspirin use to prevent colorectal cancer.

Do published patient decision aids for end-of-life care address patients' decision-making needs? A systematic review and critical appraisal.

BACKGROUND: Many decisions are made by patients in their last months of life, creating complex decision-making needs for these individuals. Identifying whether currently existing patient decision aids address the full range of these patient decision-making needs will better inform end-of-life decision support in clinical practice. AIMS AND DESIGN: This systematic review aimed to (a) identify the range of patients' decision-making needs and (b) assess the extent to which patient decision aids address these needs. DATA SOURCES: MEDLINE, PsycINFO and CINAHL electronic literature databases were searched (January 1990-January 2017), supplemented by hand-searching strategies. Eligible literature reported patient decision-making needs throughout end-of-life decision-making or were evaluations of patient decision aids. Identified decision aid content was mapped onto and assessed against all patient decision-making needs that were deemed 'addressable'. RESULTS: Twenty-two studies described patient needs, and seven end-of-life patient decision aids were identified. Patient needs were categorised, resulting in 48 'addressable' needs. Mapping needs to patient decision aid content showed that 17 patient needs were insufficiently addressed by current patient decision aids. The most substantial gaps included inconsistent acknowledgement, elicitation and documentation of how patient needs varied individually for the level of information provided, the extent patients wanted to participate in decision-making, and the extent they wanted their families and associated healthcare professionals to participate. CONCLUSION: Patient decision-making needs are broad and varied. Currently developed patient decision aids are insufficiently addressing patient decision-making needs. Improving future end-of-life patient decision aid content through five key suggestions could improve patient-focused decision-making support at the end of life.

Impact of low-dose CT screening on smoking cessation among high-risk participants in the UK Lung Cancer Screening Trial.

BACKGROUND: Smoking cessation was examined among high-risk participants in the UK Lung Cancer Screening (UKLS) Pilot Trial of low-dose CT screening. METHODS: High-risk individuals aged 50-75 years who completed baseline questionnaires were randomised to CT screening (intervention) or usual care (no screening control). Smoking habit was determined at baseline using self-report. Smokers were asked whether they had quit smoking since joining UKLS at T1 (2 weeks after baseline scan results or control assignment) and T2 (up to 2 years after recruitment). Intention-to-treat (ITT) regression analyses were undertaken, adjusting for baseline lung cancer distress, trial site and sociodemographic variables. RESULTS: Of a total 4055 individuals randomised to CT screening or control, 1546 were baseline smokers (759 intervention, 787 control). Smoking cessation rates were 8% (control n=36/479) versus 14% (intervention n=75/527) at T1 and 21% (control n=79/377) versus 24% (intervention n=115/488) at T2. ITT analyses indicated that the odds of quitting among screened participants were significantly higher at T1 (adjusted OR (aOR) 2.38, 95% CI 1.56 to 3.64, p<0.001) and T2 (aOR 1.60, 95% CI 1.17 to 2.18, p=0.003) compared with control. Intervention participants who needed additional clinical investigation were more likely to quit in the longer term compared with the control group (aOR 2.29, 95% CI 1.62 to 3.22, p=0.007) and those receiving a negative result (aOR 2.43, 95% CI 1.54 to 3.84, p<0.001). CONCLUSIONS: CT lung cancer screening for high-risk participants presents a teachable moment for smoking cessation, especially among those who receive a positive scan result. Further behavioural research is needed to evaluate optimal strategies for integrating smoking cessation intervention with stratified lung cancer screening. TRIAL REGISTRATION NUMBER: Results, ISRCTN 78513845.

Information needs and decision-making preferences of older women offered a choice between surgery and primary endocrine therapy for early breast cancer.

OBJECTIVES: To establish older women's (≥75 years) information preferences regarding 2 breast cancer treatment options: surgery plus adjuvant endocrine therapy versus primary endocrine therapy. To quantify women's preferences for the mode of information presentation and decision-making (DM) style. METHODS: This was a UK multicentre survey of women, ≥75 years, who had been offered a choice between PET and surgery at diagnosis of breast cancer. A questionnaire was developed including 2 validated scales of decision regret and DM preferences. RESULTS: Questionnaires were sent to 247 women, and 101 were returned (response rate 41%). The median age of participants was 82 (range 75 to 99), with 58 having had surgery and 37 having PET. Practical details about the impact, safety, and efficacy of treatment were of most interest to participants. Of least interest were cosmetic outcomes after surgery. Information provided verbally by doctors and nurses, supported by booklets, was preferred. There was little interest in technology-based sources of information. There was equal preference for a patient- or doctor-centred DM style and lower preference for a shared DM style. The majority (74%) experienced their preferred DM style. Levels of decision regret were low (15.73, scale 0-100). CONCLUSIONS: Women strongly preferred face to face information. Written formats were also helpful but not computer-based resources. Information that was found helpful to women in the DM process was identified. The study demonstrates many women achieved their preferred DM style, with a preference for involvement, and expressed low levels of decision regret.

Long-term psychosocial outcomes of low-dose CT screening: results of the UK Lung Cancer Screening randomised controlled trial.

BACKGROUND: The UK Lung Cancer Screening (UKLS) trial is a randomised pilot trial of low-dose CT (LDCT) screening for individuals at high risk of lung cancer. We assessed the long-term psychosocial impact on individuals participating in the UKLS trial. METHODS: A random sample of individuals aged 50-75 years was contacted via primary care. High-risk individuals who completed T0 questionnaires (baseline) were randomised to LDCT screening (intervention) or usual care (no screening control). T1 questionnaires were sent 2 weeks after baseline scan results or control assignment. T2 questionnaires were sent up to 2 years after recruitment. Measures included cancer distress, anxiety, depression and decision satisfaction. RESULTS: A total of 4037 high-risk individuals were randomised and they completed T0 questionnaires (n=2018 intervention, n=2019 control). Cancer distress was higher at T1 in intervention arm participants who received positive screening results (p≤0.001), but not at T2 (p=0.04). T2 anxiety (p≤0.001) and depression (p≤0.01) were higher in the control arm, but the absolute differences were small and not clinically relevant. At both time points, fewer control than screened participants were satisfied with their decision to participate in UKLS (p≤0.001). Regardless of trial allocation, cancer distress was higher in women (p≤0.01), participants aged ≤65 years (p≤0.001), current smokers (p≤0.001), those with lung cancer experience (p≤0.001) and those recruited from the Liverpool area (p≤0.001). CONCLUSION: Lung cancer screening using LDCT appears to have no clinically significant long-term psychosocial impact on high-risk participants. Strategies for engaging and supporting underserved groups are the key to implement routine lung cancer screening in the UK. TRIAL REGISTRATION NUMBER: ISRCTN 78513845; results.

The balance of clinician and patient input into treatment decision-making in older women with operable breast cancer.

OBJECTIVE: Primary endocrine therapy (PET) is an alternative to surgery for oestrogen receptor positive operable breast cancer in some older women. However the decision to offer PET involves complex trade-offs and is influenced by both patient choice and healthcare professional (HCP) preference. This study aimed to compare the views of patients and HCPs about this decision and explore decision-making (DM) preferences and whether these are taken into account during consultations. METHODS: This multicentre, UK, mixed methods study had three components: (a) questionnaires to older women undergoing counseling about breast cancer treatment options which assessed their DM preferences and realities; (b) qualitative interviews with older women with operable breast cancer offered a choice of either surgery or PET and (c) qualitative interviews with HCPs (both of which focused on DM preferences in this setting). RESULTS: Thirty-three patients and 34 HCPs were interviewed. A range of opinions about patient involvement in DM were identified. Patients indicated varying preferences for DM involvement which were variably taken into account by HCPs. These qualitative findings were broadly supported by the questionnaire results. Most patients (536/729; 73.5%) achieved their preferred DM style; however, the remainder felt that their DM preferences had not been taken into consideration. CONCLUSIONS: These results suggest that whilst many older women achieve their desired level of DM engagement, some do not, raising the possibility that they may be making choices which are not concordant with their treatment preferences.

The information and decision support needs of older women (>75 yrs) facing treatment choices for breast cancer: a qualitative study.

OBJECTIVE: Primary Endocrine Therapy (PET) is a good alternative to surgery for breast cancer in older frailer women. Overall survival rates are equivalent although rates of local control are inferior. There is little research regarding the decision support needs of older patients faced with this choice. This qualitative study aimed to explore these among older breast cancer patients offered a choice of treatment, as the basis to develop an appropriate decision support tool. METHODS: Semi-structured interviews were undertaken with older women (>75 years) with breast cancer who had been offered a choice of PET or surgery at diagnosis. Women's involvement in their treatment decision and support for the process were explored and analysed using framework analysis. RESULTS: Thirty-three interviews were undertaken (median age 82, range 75-95 years, 22 PET, 11 surgery). Most women, regardless of treatment choice, wanted tailored information about the different treatment options, their impact on independence, the practicalities of treatment and the risk of recurrence and spread. Surgery was the treatment of choice in women wanting optimal disease control; those choosing PET felt that they were 'too old' for surgery and wanted minimal disruption. CONCLUSIONS: Older women described making active treatment decisions. However, some knowledge was inaccurate. Women wanted information and decision support from their clinicians along with a specific tailored information booklet to support this process.

Understanding older women's decision making and coping in the context of breast cancer treatment.

BACKGROUND: Primary endocrine therapy (PET) is a recognised alternative to surgery followed by endocrine therapy for a subset of older, frailer women with breast cancer. Choice of treatment is preference-sensitive and may require decision support. Older patients are often conceptualised as passive decision-makers. The present study used the Coping in Deliberation (CODE) framework to gain insight into decision making and coping processes in a group of older women who have faced breast cancer treatment decisions, and to inform the development of a decision support intervention (DSI). METHODS: Semi-structured interviews were carried out with older women who had been offered a choice of PET or surgery from five UK hospital clinics. Women's information and support needs, their breast cancer diagnosis and treatment decisions were explored. A secondary analysis of these interviews was conducted using the CODE framework to examine women's appraisals of health threat and coping throughout the deliberation process. RESULTS: Interviews with 35 women aged 75-98 years were analysed. Appraisals of breast cancer and treatment options were sometimes only partial, with most women forming a preference for treatment relatively quickly. However, a number of considerations which women made throughout the deliberation process were identified, including: past experiences of cancer and its treatment; scope for choice; risks, benefits and consequences of treatment; instincts about treatment choice; and healthcare professionals' recommendations. Women also described various strategies to cope with breast cancer and their treatment decisions. These included seeking information, obtaining practical and emotional support from healthcare professionals, friends and relatives, and relying on personal faith. Based on these findings, key questions were identified that women may ask during deliberation. CONCLUSIONS: Many older women with breast cancer may be considered involved rather than passive decision-makers, and may benefit from DSIs designed to support decision making and coping within and beyond the clinic setting.

Satisfaction with remote consultations in primary care during COVID-19: a population survey of UK adults.

BACKGROUND: Mode of access to primary care changed during the COVID-19 pandemic; remote consultations became more widespread. With remote consultations likely to continue in UK primary care, it is important to understand people's perceptions of remote consultations and identify potential resulting inequalities. AIM: To assess satisfaction with remote GP consultations in the UK during the COVID-19 pandemic and identify demographic variation in satisfaction levels. DESIGN AND SETTING: A cross-sectional survey from the second phase of a large UK-based study, which was conducted during the COVID-19 pandemic. METHOD: In total, 1426 adults who self-reported having sought help from their doctor in the past 6 months completed an online questionnaire (February to March 2021). Items included satisfaction with remote consultations and demographic variables. Associations were analysed using multivariable regression. RESULTS: A novel six-item scale of satisfaction with remote GP consultations had good psychometric properties. Participants with higher levels of education had significantly greater satisfaction with remote consultations than participants with mid-level qualifications (B = -0.82, 95% confidence interval [CI] = -1.41 to -0.23) or those with low or no qualifications (B = -1.65, 95% CI = -2.29 to -1.02). People living in Wales reported significantly higher satisfaction compared with those living in Scotland (B = -1.94, 95% CI = -3.11 to -0.78), although caution is warranted due to small group numbers. CONCLUSION: These findings can inform the use and adaptation of remote consultations in primary care. Adults with lower educational levels may need additional support to improve their experience and ensure equitable care via remote consultations.

A qualitative study of women's experiences of familial ovarian cancer screening.

OBJECTIVE: One risk management strategy that women at increased familial risk of ovarian cancer may use is screening. Until recently, this has been available as part of the UK Familial Ovarian Cancer Screening Study (UKFOCSS), using ultrasound scans of the ovaries and tumour marker blood tests. The present study aimed to gain an in-depth understanding of women's experiences of participating in ovarian cancer screening. METHODS: Semi-structured interviews were conducted with 48 UKFOCSS participants. Interviews were recorded, transcribed and relevant sections analysed using a framework approach. RESULTS: Screening provided women with reassurance which they found beneficial. A sense of privilege, as well as feeling proactive in potentially detecting ovarian cancer at an early stage was described. The wider benefit to research and the potential impact this could have on others was also important to women. Negative experiences of screening included worry about the screening tests and results, false reassurance by test results and disappointment with ineffective screening. Aspects of the screening study, such as the logistics, organisation and communication, were described as both good and problematic. When weighed up by the women, most described an overall positive experience of screening. CONCLUSIONS: Women reported both positive and negative experiences of screening. Overall, screening seemed to be an acceptable risk management strategy to most women who participated in this interview study. Improvements could be made particularly in helping women to understand the limitations of familial ovarian cancer screening in order to avoid false reassurance.

Acceptability of alternative technologies compared with faecal immunochemical test and/or colonoscopy in colorectal cancer screening: A systematic review.

OBJECTIVE: Colorectal cancer (CRC) is the third most common cancer and the second largest cause of cancer-related death worldwide. Current CRC screening in various countries involves stool-based faecal immunochemical testing (FIT) and/or colonoscopy, yet public uptake remains sub-optimal. This review assessed the literature regarding acceptability of alternative CRC screening modalities compared to standard care in average-risk adults. METHOD: Systematic searches of MEDLINE, EMBASE, CINAHL, Cochrane and Web of Science were conducted up to February 3rd, 2022. The alternative interventions examined were computed tomography colonography, flexible sigmoidoscopy, colon capsule endoscopy and blood-based biomarkers. Outcomes for acceptability were uptake, discomfort associated with bowel preparation, discomfort associated with screening procedure, screening preferences and willingness to repeat screening method. A narrative data synthesis was conducted. RESULTS: Twenty-one studies met the inclusion criteria. Differences between intervention and comparison modalities in uptake did not reach statistical significance in most of the included studies. The findings do suggest FIT as being more acceptable as a screening modality than flexible sigmoidoscopy. There were no consistent significant differences in bowel preparation discomfort, screening procedure discomfort, screening preference and willingness to repeat screening between the standard care and alternative modalities. CONCLUSION: Current evidence comparing standard colonoscopy and stool-based CRC screening with novel modalities does not demonstrate any clear difference in acceptability. Due to the small number of studies available and included in each screening comparison and lack of observed differences, further research is needed to explore factors influencing acceptability of alternative CRC modalities that might result in improvement in population uptake within different contexts.

Withdrawal from familial ovarian cancer screening for surgery: findings from a psychological evaluation study (PsyFOCS).

OBJECTIVE: A prospective psychological evaluation study of familial ovarian cancer screening (PsyFOCS) is underway in partnership with the UK Familial Ovarian Cancer Screening Study (UK FOCSS Phase 2). One of the aims of PsyFOCS is to examine factors associated with withdrawal from the UK FOCSS prior to the onset of 4-monthly screening. METHOD: 1999 of 3224 women completed a baseline questionnaire. 110 (5.5%) women withdrew from screening prior to their first routine Phase 2 screen, of which 73 (66.4% of withdrawals) had withdrawn because they had undergone removal of their ovaries and fallopian tubes (withdrawn group). The comparison group consisted of 1868 women who remained on screening. The baseline questionnaire included measures of cancer-specific distress, anxiety, depression and illness perceptions. RESULTS: Logistic regression analysis indicated that having had prior annual (Phase 1) screening (OR=13.34, p<.01), past experience of further tests (OR=2.37, p<.01) and greater cancer-specific distress (OR=1.38, p<.01) were associated with withdrawal for surgery. Belief in ageing as a cause of ovarian cancer was also associated with withdrawal (OR=1.32, p=.05). CONCLUSION: These cross-sectional data suggest that withdrawal from familial ovarian cancer screening may be influenced by both clinical and psychological factors. These may reflect women's experience of the drawbacks of screening and increased concern about ovarian cancer risk, as well as having opportunities to consider surgery as an alternative risk management strategy whilst using screening as an interim measure.

Psychological outcomes of familial ovarian cancer screening: no evidence of long-term harm.

OBJECTIVES: Ovarian cancer screening for women at increased genetic risk in the UK involves 4-monthly CA125 tests and annual ultrasound, with further tests prompted by an abnormal result. The study evaluated the longer-term psychological and behavioural effects of frequent ovarian screening. METHODS: Women completed T1 questionnaires before their first routine 4-monthly CA125 test, and T2 follow-up questionnaires one week after their result. Women with abnormal results completed a further questionnaire one week after return to routine screening (T3 primary end-point). T4 questionnaires were sent at nine months. Measures included cancer distress, general anxiety/depression, reassurance, and withdrawal from screening. RESULTS: A total 1999 (62%) of 3224 women completed T1 questionnaires. T2 questionnaires were completed by 1384/1609 participants (86%): 1217 (89%) with normal results and 167/242 (69%) with abnormal results. T3 questionnaires were completed by 141/163 (87%) women, with 912/1173 (78%) completing T4 questionnaires. Analysis of covariance indicated that, compared to women with normal results, women with abnormal results reported moderate cancer distress (F = 27.47, p ≤ .001, η(2) = 0.02) one week after their abnormal result and were significantly more likely to withdraw from screening (OR = 4.38, p ≤ .001). These effects were not apparent at T3 or T4. The effect of screening result on general anxiety/depression or overall reassurance was not significant. CONCLUSIONS: Women participating in frequent ovarian screening who are recalled for an abnormal result may experience transient cancer-specific distress, which may prompt reconsideration of risk management options. Health professionals and policy makers may be reassured that frequent familial ovarian screening does not cause sustained psychological harm.

Effectiveness of technological interventions to improve healthcare communication with children with long-term conditions: A systematic review and meta-analysis of randomised controlled trials.

OBJECTIVE: This systematic review and meta-analysis aimed to evaluate the effectiveness of technological interventions used to improve communication between healthcare professionals (HCPs) and children with long-term conditions (LTCs). METHODS: PROSPERO: CRD42020221977. Five electronic databases were searched from inception to May 2021 for randomised controlled trials. Study characteristics were described and random-effects meta-analysis was conducted. RESULTS: Nineteen studies were included, involving 1995 participants. Technological interventions were found to significantly improve participants' knowledge of their condition (standardised mean difference [SMD] 0.39; 95% CI 0.07-0.71; p = 0.02) and lead to a more internal health locus of control (SMD 0.50; 95% CI 0.25-0.76; p < 0.0001). There was no statistically significant improvement in physiological measures or emergency healthcare use. CONCLUSION: This systematic review showed some benefits of using technology to improve communication between HCPs and children with LTCs. Future primary research should use rigorous methods for subsequent reviews to draw conclusions with greater confidence in the evidence. Establishing a core outcome set within this field of study would enable consistent measurement of outcomes. PRACTICE IMPLICATIONS: Our findings indicate value in integrating communication technologies in the child health setting, aiming to establish greater continuity of care and maintain patient-clinician relationships between healthcare visits.

Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial.

BACKGROUND: The Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patients), two decision support interventions (DESIs). Both DESIs were used in the intervention arm and each comprised an online risk prediction model, brief decision aid and information booklet. One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not. METHODS: Sixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used. RESULTS: Eighty-two patients, mean age 75.5 (range 70-93), provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high levels of satisfaction with the process. Participants' responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful. CONCLUSIONS: Clinicians who participated were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice. TRIAL REGISTRATION: ISRCTN46099296 . Registered on 11 August 2016-retrospectively registered.

Treatment choices for older women with primary operable breast cancer and cognitive impairment: Results from a prospective, multicentre cohort study.

OBJECTIVES: The presence of dementia co-existing with a diagnosis of breast cancer may render management more challenging and have a substantial impact on oncological outcomes. The aim of this study was to examine the treatment and outcomes of older women with co-existing cognitive impairment and primary breast cancer. MATERIALS AND METHODS: A prospective, multicentre UK cohort study of women aged 70 years or over with primary operable breast cancer. Patients with and without cognitive impairment were compared to assess differences in treatment and survival outcomes. RESULTS: In total, 3416 women were recruited between 2013 and 2018. Of these, 478 (14%) had a diagnosis of dementia or cognitive impairment, subcategorised as mild, moderate and severely impaired. Up to 85% of women with normal cognition underwent surgery compared to 74%, 61% and 40% with mild, moderate, and severe impairment (p = 0.001). Among women at higher risk of recurrence, the uptake of chemotherapy was 25% for cognitively normal women compared to 20%, 22% and 12% for mild, moderate and severe impairment groups (p = 0.222). Radiotherapy use was similar in the subgroups. Although patients with cognitive impairment had shorter overall survival (HR: 2.10, 95% CI: 1.77-2.50, p < 0.001), there were no statistically significant differences in breast cancer specific or progression-free survival. CONCLUSION: Cognitive impairment appears to play a significant part in deciding how to treat older women with breast cancer. Standard treatment may be over-treatment for some women with severe dementia and careful consideration must be given to a more tailored approach in these women.

Bridging the age gap in breast cancer. Impacts of omission of breast cancer surgery in older women with oestrogen receptor positive early breast cancer. A risk stratified analysis of survival outcomes and quality of life.

BACKGROUND: Age-related breast cancer treatment variance is widespread with many older women having primary endocrine therapy (PET), which may contribute to inferior survival and local control. This propensity-matched study determined if a subgroup of older women may safely be offered PET. METHODS: Multicentre, prospective, UK, observational cohort study with propensity-matched analysis to determine optimal allocation of surgery plus ET (S+ET) or PET in women aged ≥70 with breast cancer. Data on fitness, frailty, cancer stage, grade, biotype, treatment and quality of life were collected. Propensity-matching (based on age, health status and cancer stage) adjusted for allocation bias when comparing S+ET with PET. FINDINGS: A total of 3416 women (median age 77, range 69-102) were recruited from 56 breast units-2854 (88%) had ER+ breast cancer: 2354 had S+ET and 500 PET. Median follow-up was 52 months. Patients treated with PET were older and frailer than patients treated with S+ET. Unmatched overall survival was inferior in the PET group (hazard ratio, (HR) 0.27, 95% confidence interval (CI) 0.23-0.33, P < 0.001). Unmatched breast cancer-specific survival (BCSS) was also inferior in patients treated with PET (HR: 0.41, CI: 0.29-0.58, P < 0.001 for BCSS). In the matched analysis, PET was still associated with an inferior overall survival (HR = 0.72, 95% CI: 0.53-0.98, P = 0.04) but not BCSS (HR = 0.74, 95% CI: 0.40-1.37, P = 0.34) although at 4-5 years subtle divergence of the curves commenced in favor of surgery. Global health status diverged at certain time points between groups but over 24 months was similar when adjusted for baseline variance. INTERPRETATION: For the majority of older women with early ER+ breast cancer, surgery is oncologically superior to PET. In less fit, older women, with characteristics similar to the matched cohort of this study (median age 81 with higher comorbidity and functional impairment burdens, the BCSS survival differential disappears at least out to 4-5 year follow-up, suggesting that for those with less than 5-year predicted life-expectancy (>90 years or >85 with comorbidities or frailty) individualised decision making regarding PET versus S+ET may be appropriate and safe to offer. The Age Gap online decision tool may support this decision-making process (https://agegap.shef.ac.uk/). TRIAL REGISTRATION NUMBER: ISRCTN: 46099296.

Observational cohort study in older women with early breast cancer: Use of radiation therapy and impact on health-related quality of life and mortality.

BACKGROUND: Radiotherapy reduces in-breast recurrence risk in early breast cancer (EBC) in older women. This benefit may be small and should be balanced against treatment effect and holistic patient assessment. This study described treatment patterns according to fitness and impact on health-related quality-of-life (HRQoL). METHODS: A multicentre, observational study of EBC patients aged ≥ 70 years, undergoing breast-conserving surgery (BCS) or mastectomy, was undertaken. Associations between radiotherapy use, surgery, clinico-pathological parameters, fitness based on geriatric parameters and treatment centre were determined. HRQoL was measured using the European Organisation for the Research and Treatment of Cancer (EORTC) questionnaires. RESULTS: In 2013-2018 2811 women in 56 UK study centres underwent surgery with a median follow-up of 52 months. On multivariable analysis, age and tumour risk predicted radiotherapy use. Among healthier patients (based on geriatric assessments) with high-risk tumours, 534/613 (87.1%) having BCS and 185/341 (54.2%) having mastectomy received radiotherapy. In less fit individuals with low-risk tumours undergoing BCS, 149/207 (72.0%) received radiotherapy. Radiotherapy effects on HRQoL domains, including breast symptoms and fatigue were seen, resolving by 18 months. CONCLUSION: Radiotherapy use in EBC patients ≥ 70 years is affected by age and recurrence risk, whereas geriatric parameters have limited impact regardless of type of surgery. There was geographical variation in treatment, with some fit older women with high-risk tumours not receiving radiotherapy, and some older, low-risk, EBC patients receiving radiotherapy after BCS despite evidence of limited benefit. The impact on HRQoL is transient.