Psychological morbidity associated with ovarian cancer screening: results from more than 23,000 women in the randomised trial of ovarian cancer screening (UKCTOCS).

OBJECTIVE: To examine the psychological sequelae associated with abnormal screening in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). DESIGN: Prospective, longitudinal randomised control trial. SETTING: Sixteen UKCTOCS centres. SAMPLE: Women aged 50-70 years randomised to annual multimodal screening, ultrasound screening or control groups. METHODS: Two groups were followed for 7 years: (1) a random sample (n = 1339), taken from all three study groups; and (2) an events sample (n = 22,035) of women with abnormal screens resulting in the need for repeat testing of either low or higher level intensity. MAIN OUTCOME MEASURES: Patient-reported measures of anxiety (scores ranging from 20 to 80) and psychological morbidity. RESULTS: In the random sample the mean difference between anxiety scores after a repeat screening and those following an annual screening was 0.4 (95% CI -0.46, 1.27), and in the events sample it was 0.37 (95% CI 0.23, 0.51). The risk of psychological morbidity was only increased in the event sample for women requiring higher level repeat screening (OR 1.28; 95% CI 1.18, 1.39). The risk of psychological morbidity in women with ovarian cancer was higher at both 6 weeks (OR 16.2; 95% CI 9.19, 28.54) and 6 months (OR 3.32; 95% CI 1.91, 5.77) following surgery. CONCLUSIONS: Screening does not appear to raise anxiety but psychological morbidity is elevated by more intense repeat testing following abnormal annual screens, and in women after surgical treatment for ovarian cancer.

Drivers and barriers to patient participation in RCTs.

BACKGROUND: Recruitment of patients into randomised clinical trials (RCTs) is essential for treatment evaluation. Appreciation of the barriers and drivers towards participation is important for trial design, communication and information provision. METHOD: As part of an intervention to facilitate effective multidisciplinary team communication about RCTs, cancer patients completed two study-specific questionnaires following trial discussions. One questionnaire examined reasons why patients accepted or declined trial entry, the other perceptions about their health-care professionals' (HCPs) information giving. RESULTS: Questionnaires were completed by 74% (358/486) of patients approached; of these 81% (291/358) had joined an RCT, 16% (56/358) had declined and 3% (11/358) were undecided. Trial participation status of the 128 patients not returning questionnaires is unknown. Trial acceptance was not dependent on disease stage, tumour type, sex or age. Satisfaction with trial information and HCPs' communication was generally very good, irrespective of participation decisions. The primary reason given for trial acceptance was altruism (40%; 110/275), and for declining, trust in the doctor (28%; 12/43). Decliners preferred doctors to choose their treatment rather than be randomised (54% vs 39%; P<0.027). Acceptors were more likely to perceive doctors as wanting them to join trials (54% vs 30%; P<0.001). Trial type, that is, standard treatment vs novel or different durations of treatment, also influenced acceptance rates. CONCLUSION: The drivers and barriers to trial participation are partly related to trial design. Unease about randomisation and impact of duration on treatment efficacy are barriers for some. Altruism and HCPs' perceived attitudes are powerful influencing factors.

Adjuvant chemotherapy in elderly women with breast cancer (AChEW): an observational study identifying MDT perceptions and barriers to decision making.

BACKGROUND: As few older women with breast cancer receive adjuvant chemotherapy, we examined the barriers and perceptions of 24 UK NHS multidisciplinary breast cancer teams to offering this treatment to women ≥70 years. PATIENTS AND METHODS: Questionnaires regarding 803 patients with newly diagnosed breast cancer were completed by specialist teams following discussion or outpatient consultation. RESULTS: Of 803 patients, 116 (14%), all <85 years, were offered chemotherapy and 66 (8%) received it. Only 94 of 309 (30%) of women with high-risk disease were offered chemotherapy, and 53 (17%) received it. The most common reasons for not offering chemotherapy were 'other treatments more appropriate' (usually patients with ER-positive tumours) or 'benefits too small' (63% and 54% of patients, respectively). Co-morbidities and frailty were less common reasons but became more frequent with increasing age. Recommendations regarding chemotherapy were made in the absence of documented HER2 and performance status in 29% and 33%, respectively. Treatment offered varied considerably between cancer centres. CONCLUSIONS: National guidelines need development describing the minimally acceptable data for decision making, incorporating objective fitness measures and specific treatment recommendations. Such guidelines will require educational support for implementation but should standardise care and improve chemotherapy uptake in this increasing population of older patients.

ARIX: a randomised trial of acupuncture v oral care sessions in patients with chronic xerostomia following treatment of head and neck cancer.

BACKGROUND: Radiation treatment of head and neck cancer can cause chronic xerostomia which impairs patients' quality of life. The study reported here examined the efficacy of acupuncture in alleviating xerostomia symptoms especially dry mouth. PATIENTS AND METHODS: A total of 145 patients with chronic radiation-induced xerostomia >18 months after treatments were recruited from seven UK cancer centres. The study employed a randomised crossover design with participants receiving two group sessions of oral care education and eight of acupuncture using standardised methods. Patient-reported outcome (PROs) measures were completed at baseline and weeks 5, 9, 13, 17, and 21. The primary outcome was improvement in dry mouth. OBJECTIVE: saliva measurements were also carried out. RESULTS: Acupuncture compared with oral care, produced significant reductions in patient reports of severe dry mouth (OR = 2.01, P = 0.031) sticky saliva (OR = 1.67, P = 0.048), needing to sip fluids to swallow food (OR = 2.08, P = 0.011) and in waking up at night to drink (OR = 1.71, P = 0.013). There were no significant changes in either stimulated or unstimulated saliva measurements over time. CONCLUSION: Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia.

Long-term assessment of quality of life in the Intergroup Exemestane Study: 5 years post-randomisation.

BACKGROUND: The Intergroup Exemestane Study (IES) (ISRCTN11883920) demonstrated improved survival for postmenopausal women with ER-positive/unknown primary breast cancer who switched to exemestane after 2-3 years tamoxifen, compared with those continuing on tamoxifen to complete 5 years therapy. This was achieved without detriment to on-treatment quality-of-life (QoL). We report on- and post-treatment QoL impact in IES. METHODS: A total of 582 patients from 8 countries participated in the QoL substudy. Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine symptom subscale (ES) were completed at baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 months. The primary endpoint was FACT-B Trial Outcome Index (TOI); secondary endpoints included severity of individual endocrine symptoms. RESULTS: Both the groups showed gradual improvement in overall QoL and lessening of total endocrine symptoms post treatment compared with baseline (P<0.002). There was no evidence of any between-group differences in TOI. Vasomotor complaints remained high on treatment. Vaginal discharge was more frequent (P<0.01) with tamoxifen up to 24 months from baseline. In both the groups, post-treatment libido did not recover to baseline levels. CONCLUSION: Clinical benefits of switching to exemestane are accompanied by good overall QoL. Although some symptoms persist, the majority of endocrine symptoms improve after treatment completion.

The preferences and experiences of different bisphosphonate treatments in women with breast cancer.

OBJECTIVE: The objective of this study was to examine women's experiences with oral and intravenous (i.v.) bisphosphonate therapy, the impact that treatment had on bone pain and Quality of Life (QoL), and their preferences if choice were available between oral and i.v. administration. METHODS: This was a prospective study of women with metastatic breast cancer receiving either oral or i.v. bisphosphonate therapy. Semi-structured interview techniques and QoL questionnaires were employed. Participants in the study were interviewed three times, once in person and twice by telephone. RESULTS: A total of 79 patients from eight UK hospitals participated in the study; 35 were receiving oral bisphosphonate medication and 44 i.v. treatments. Self-reported adherence to oral therapy was good although 21% had chosen not to take their drugs at some time. Most had adapted their lifestyle to accommodate oral therapy with 29/37(74%) completely satisfied. However 9/37(24%) expressed dissatisfaction with constraints especially the time required to stand upright after taking their tablets. By 6 months 23/25 (91%) of patients receiving (i.v.) therapies were generally satisfied with the frequency and 22/25 (88%) with the convenience especially if given concurrently with chemotherapy. Overall 25/54 (46%) patients reported improved bone pain scores on the validated FACT-BP scale from baseline to 6 months. CONCLUSIONS: Both oral and i.v. therapies have disadvantages but were acceptable to most patients some of whom had reduced bone pain over time. More data regarding acceptability, adherence, and patients' preference for bisphosphonate therapies are required. Until randomised trials demonstrate superior efficacy for one mode of bisphosphonate therapy over another, we suggest offering patients a choice of bisphosphonate therapy.

The attitudes of 1066 patients with cancer towards participation in randomised clinical trials.

BACKGROUND: barriers to randomised clinical trial (RCT) recruitment include failure to identify eligible patients, reluctance of staff to approach them and attitudes of some health-care professionals and patients. As part of a larger UK prospective study examining the communication and involvement in RCTs of 22 multidisciplinary teams in Wales, we also assessed the attitudes of patients they treat towards trials. METHODS: out of 1146 patients attending outpatient departments who were approached, 1146 (93%) completed the seven-item Attitudes to Randomised Trials Questionnaire (ARTQ), probing their general attitudes towards medical research and likely participation in a hypothetical two-arm RCT. RESULTS: randomisation initially deterred many patients from endorsing a willingness to participate. However, if information about the trial logic, voluntary nature and rights to withdraw were provided, together with further treatment details, 83% (886 out of 1066) would potentially participate. Other variables associated with a positive inclination towards participation included previous trial experience (P<0.01), male gender (P<0.01) and younger age, with patients > or =70 years less likely to consider trial entry (P<0.01). CONCLUSION: the majority of patients were receptive to RCT participation. Many of those initially disinclined because of randomisation would consider joining if given further details that form part of standard GCP consent guidelines. These data show the importance and need for clear communication and information to encourage RCT participation. Evidence-based training courses are available to assist with this.

Implications of subcutaneous or intravenous delivery of trastuzumab; further insight from patient interviews in the PrefHer study.

BACKGROUND: The 2 Cohort randomised PrefHer trial examined the preferences of HER2+ve primary breast cancer patients for intravenous (IV) or subcutaneous (SC) delivery of trastuzumab via a Single Injectable Device (SID) or hand-held syringe (HHS). The novel approach and design of the study permitted an in-depth exploration of patients' experiences, the impact that different modes of delivery had on patients' well-being and implications for future management. METHODS: The preferences, experiences and general comments of patients in the PrefHer study were collected via specific semi-structured interview schedules. Exploratory analyses of data were conducted using standard methodology. The final question invited patients to make further comments, which were divided into 9 thematic categories - future delivery, compliments, time/convenience, practical considerations, pain/discomfort, study design, side-effects, psychological impact, and perceived efficacy. RESULTS: 267/467 (57%) patients made 396 additional comments, 7 were neutral, 305 positive and 86 negative. The three top categories generating the largest number of comments were compliments and gratitude about staff and being part of PrefHer (75/396; 19%), the potential future delivery of SC trastuzumab (73/396; 18%), and practical considerations about SC administration (60/396; 15%). CONCLUSIONS: Eliciting patient preferences about routes of administration of drugs via comprehensive interviews within a randomised cross-over trial yielded rich and important information. The few negative comments made demonstrated a need for proper staff training in SC administration Patients were grateful to have been part of the trial, and would have liked to continue with SC delivery. The possibility of home administration in the future also seemed acceptable. EUDRACT NUMBER: 2010-024099-25.

Women in the NHS. Leaving the laurels behind.

Half the women profiled in a report of top managers in 1993 have now left the NHS. Only one is still in the same job. The number of women in chief executive posts has not increased substantially since 1993. There seems to be little appetite to crack the glass celling which still exists at the top of the NHS.

Communication skills training for breast cancer teams talking about trials.

OBJECTIVES: We modified an educational intervention developed to improve communication about clinical trials and enhance multidisciplinary team (MDT) working for specialist breast cancer MDTs. We assessed the effect of one day MDT training on team members' awareness & clarity about trials in their portfolio, and individuals' confidence & communication about clinical trials. MATERIALS AND METHODS: Six MDTs in England participated between May 2012 and January 2013. Teams identified a breast trial from their portfolio that was about to start or one for which recruitment was proving difficult. Participants completed questionnaires identifying their roles and awareness of trial activity. The interactive workshop contained several generic elements: including PPT presentations, relevant exercises, and practical sessions but were also customised to fit the individual MDT requirements. Participants completed post-course questionnaires and the team leaders completed a 6-month review. RESULTS: Eighty healthcare professionals participated. There were significant positive changes (P < 0.001) post-workshop for all 15 key areas probed concerning awareness and clarity about the trial(s) discussed during the training intervention. Six month questionnaire data revealed 5/6 teams had greater awareness of actual roles played by their colleagues and that more team members were willing and able to discuss trial(s) with patients. Additionally, 5/6 team leaders said that dynamics had changed for the better and enthusiasm for trials improved. CONCLUSION: Workshops focussed on clinical trials can be conducted in one day and produce improvements in team awareness, knowledge of teams' trials portfolios and communication skills.

Teams Talking Trials: results of an RCT to improve the communication of cancer teams about treatment trials.

BACKGROUND: Previous research has shown that communication between members of multidisciplinary teams (MDTs) is often suboptimal and communication about trials between MDTs and their patients is difficult. Educational interventions can help dyadic exchanges with different aspects of trial recruitment but less work has focussed on team interventions. METHODS: 22 multidisciplinary cancer teams in the UK participated in an RCT of a novel Teams Talking Trials (TTT) Workshop aimed at improving the following: awareness, involvement, communication and recruitment to cancer trials. MDTs were randomised following either 6 or 12 months of audits, which were repeated after the intervention. Audits included numbers approached about trials, team members' attitudes, involvement and awareness of their teams' trial portfolios. RESULTS: There was no significant difference in the rate of approaching patients about trials post workshop (estimated improvement 22% higher regression coefficient of 0.2, exp. (0.2)=1.22). There was improvement in team members' involvement in trials in 4 areas (p≤0.04): the pressure to enter patients into RCTs, the likelihood of a start-up meeting to discuss a newly accepted trial, the informational role played by individuals and recognition of this HCP's role by other team members. Also, confidence in communication about RCTS increased and awareness of different aspects of trial management improved on all 14 aspects (p=0.001). CONCLUSION: Attendance by teams at focussed workshops designed to enhance communication and trial recruitment improved several aspects of team functioning, but a significant impact on the number of patients approached could not be demonstrated.

Reasons given by patients for participating, or not, in Phase 1 cancer trials.

BACKGROUND: Communication with patients contemplating Phase 1 cancer trial participation can be challenging. Controversy exists as to whether they are provided with sufficient information to give genuinely informed consent. We present data examining the reasons patients gave for trial entry. METHOD: Following discussions with oncologists about Phase 1 trials, participants completed a 19-item study specific 'accept or decline measure' exploring hope, expectations of benefit, altruism, concerns, and general perceptions of the trial information. They also completed 2 standardised questionnaires measuring psychological morbidity and predisposition towards optimism. RESULTS: Forty patients completed the study questionnaires. Patients were generally optimistic with few concerns about the experimental nature of Phase 1 trials. Most 36/40 (90%) consented to trial entry. Fifty-one percent thought the trial was the only treatment option available. The four main reasons for trial entry were: expectation of some medical benefit (21%); trial the best available option (21%); to maintain hope (15%) and to help with research (13%). Only one patient gave altruism as their main reason for trial participation. CONCLUSION: Patients considering Phase 1 trials may be a self-selected group with optimistic expectations of personal benefit driving trial entry rather than altruism. Achieving genuinely informed consent and avoidance of therapeutic misconceptions in such patients may be difficult.