Background: As the number of randomised controlled trials of medicines for children increases,
it becomes progressively more important to understand the experiences of parents who are asked
to enrol their child in a trial. This paper presents a narrative review of research evidence on
parents' experiences of trial recruitment focussing on qualitative research, which allows them to
articulate their views in their own words.
Discussion: Parents want to do their best for their children, and socially and legally their role is
to care for and protect them yet the complexities of the medical and research context can
challenge their fulfilment of this role. Parents are simultaneously responsible for their child and
cherish this role yet they are dependent on others when their child becomes sick. They are keen
to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the
'wrong' decision. They make judgements about the threat of the child's condition as well as the risks
of the trial yet their interpretations often differ from those of medical and research experts.
Individual parents will experience these and other complexities to a greater or lesser degree
depending on their personal experiences and values, the medical situation of their child and the
nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these
complexities if practitioners have the flexibility to tailor discussions to the needs and situation of
individual parents. In this way, parents may be helped to retain a sense that they have acted as good
parents to their child whatever decision they make.
Summary: Discussing randomised controlled trials and gaining and providing informed consent is
challenging. The unique position of parents in giving proxy consent for their child adds to this
challenge. Recognition of the complexities parents face in making decisions about trials suggests
lines for future research on the conduct of trials, and ultimately, may help improve the experience
of trial recruitment for all parties.
Compared with treatment options for early-stage breast cancer, few data exist regarding the optimal use of chemotherapy for metastatic breast cancer (MBC). The choice of using a combination of cytotoxic chemotherapies vs sequential single agents is controversial. At the 6th European Breast Cancer Conference, the European School of Oncology Metastatic Breast Cancer Task Force convened an open debate on the relative benefits of combination vs sequential therapy. Based on the available data, the Task Force recommends sequential monotherapy as the preferred choice in advanced disease, in the absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control. Patient- and disease-related factors should be used to choose between combination and sequential single-agent chemotherapy for MBC. Additional research is needed to determine the impact of therapy on patient-rated quality of life and to identify predictive factors that can be used to guide therapy.
Despite the many advances made in the treatment of cancer, communication worldwide between healthcare professionals, patients and their families remains problematic.
BACKGROUND: a distressing complication of radiotherapy treatment for head and neck cancer is xerostomia (chronic oral dryness). Xerostomia is difficult to treat conventionally but there are reports that acupuncture can help. We conducted a feasibility study to examine the acceptability of a standardised group acupuncture technique and adherence to group sessions, together with acceptability of the objective and subjective measurements of xerostomia.
METHODS: 12 males with established radiation induced xerostomia were treated in three groups of four. Each received eight weekly sessions of acupuncture using four bilateral acupuncture points (Salivary Gland 2; Modified Point Zero; Shen Men and one point in the distal radial aspect of each index finger (LI1)). Sialometry and quality of life assessments were performed at baseline and at the end of treatment. A semi-structured interview was conducted a week after completing the intervention.
RESULTS: adherence to and acceptability of the treatment and assessments was 100%. There were objective increases in the amounts of saliva produced for 6/12 patients post intervention and the majority also reported subjective improvements. Mean quality of life scores for domains related to salivation and xerostomia also showed improvement. At baseline 92% (11/12) patients reported experiencing a dry mouth "quite a bit/very much" as compared to 42% (5/12) after the treatment. Qualitative data revealed that the patients enjoyed the sessions.
CONCLUSION: the pilot study shows that a standardised group technique is deliverable and effective. The tools for objective and subjective assessment are appropriate and acceptable. Further examination in a randomised trial is now warranted.
As the world population ages, the incidence of cancer will probably also increase as it is a disease predominantly affecting older people. However, those aged 70 years or more have largely been excluded from clinical trials. This review focuses on breast cancer. Increasingly there is recognition that many older breast cancer patients are being undertreated and could and should be offered the same treatments as younger patients. Comprehensive assessment of the quality of any survival benefit from treatments is also needed to ensure that in the future older patients can make fully informed decisions about their treatment options. The aim of this overview is two-fold: first to describe methods by which to assess quality of life; and second to review the recent surgical, radiotherapy, chemotherapy and other studies that include such assessment with older breast cancer patients. Current studies are also outlined, including quality of life assessments, and recommendations are made for future research in this area.
BACKGROUND: Communication in cancer care has become a major topic of interest. Since there is evidence that ineffective communication affects both patients and oncology clinicians (physicians and nurses), so-called communication skills trainings (CSTs) have been developed over the last decade. While these trainings have been demonstrated to be effective, there is an important heterogeneity with regard to implementation and with regard to evidence of different aspects of CST. METHODS: In order to review and discuss the scientific literature on CST in oncology and to formulate recommendations, the Swiss Cancer League has organised a consensus meeting with European opinion leaders and experts in the field of CST, as well as oncology clinicians, representatives of oncology societies and patient organisations. On the basis of a systematic review and a meta-analysis, recommendations have been developed and agreed upon. RESULTS: Recommendations address (i) the setting, objectives and participants of CST, (ii) its content and pedagogic tools, (iii) organisational aspects, (iv) outcome and (v) future directions and research. CONCLUSION: This consensus meeting, on the basis of European expert opinions and a systematic review and meta-analysis, defines key elements for the current provision and future development and evaluation of CST in oncology.
Life expectancy for women with metastatic breast cancer (MBC) has increased as advances have been made in treatment and management. Consequently, when measuring the burden of MBC, womens' experiences, quality of life, and gaps in information and support needs should be considered. The BRIDGE Survey (Bridging Gaps, Expanding Outreach – Metastatic Breast Cancer Patient Survey) was conducted in the US, Europe, Latin America and Africa to evaluate patients' (pts) own perceptions of living with MBC; results are presented here.
PURPOSE: Our aim was to examine in a prospective pilot study whether standard adjuvant treatments for breast cancer can adversely affect hearing. METHODS: Eight pre/peri-menopausal women with breast cancer had middle ear analysis (tympanometry) and pure tone audiometry conducted prior to and 6 months following Fluorouracil, Epirubicin, Cyclophosphamide (FEC) or FEC plus taxotere chemotherapy treatments. RESULTS: The mean hearing thresholds in both ears showed an elevation (that is a decline) post chemotherapy treatment at 6 and 8kHz of between 20 and 30dB, which is graded as a mild hearing impairment at the higher frequency range. There were individual differences in pattern and grade within the group. CONCLUSIONS: The variability noted in the data is more than that would be anticipated for test-retest variance, suggesting that the hearing impairments are complex but genuine. The most likely cause of the reduction in hearing sensitivity is a change in oestrogen levels resulting from the breast cancer treatments.
Pulmonary metastasectomy is undertaken for a range of cancers. The questions we raise here are specifically related to colorectal cancer, the commonest tumour for which pulmonary metastasectomy is undertaken. The primary objective of metastasectomy is to increase survival. There are no randomised trials in support of this practice nor are there any other forms of controlled studies. We present a critical look at the assumption of efficacy for this surgery and propose that a trial is needed and suggest a trial design.
BACKGROUND: Ovarian cancer has a high case-fatality ratio, with most women not diagnosed until the disease is in its advanced stages. The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is a randomised controlled trial designed to assess the effect of screening on mortality. This report summarises the outcome of the prevalence (initial) screen in UKCTOCS. METHODS: Between 2001 and 2005, a total of 202 638 post-menopausal women aged 50-74 years were randomly assigned to no treatment (control; n=101 359); annual CA125 screening (interpreted using a risk of ovarian cancer algorithm) with transvaginal ultrasound scan as a second-line test (multimodal screening [MMS]; n=50 640); or annual screening with transvaginal ultrasound (USS; n=50 639) alone in a 2:1:1 ratio using a computer-generated random number algorithm. All women provided a blood sample at recruitment. Women randomised to the MMS group had their blood tested for CA125 and those randomised to the USS group were sent an appointment to attend for a transvaginal scan. Women with abnormal screens had repeat tests. Women with persistent abnormality on repeat screens underwent clinical evaluation and, where appropriate, surgery. This trial is registered as ISRCTN22488978 and with ClinicalTrials.gov, number NCT00058032. FINDINGS: In the prevalence screen, 50 078 (98.9%) women underwent MMS, and 48 230 (95.2%) underwent USS. The main reasons for withdrawal were death (two MMS, 28 USS), non-ovarian cancer or other disease (none MMS, 66 USS), removal of ovaries (five MMS, 29 USS), relocation (none MMS, 39 USS), failure to attend three appointments for the screen (72 MMS, 757 USS), and participant changing their mind (483 MMS, 1490 USS). Overall, 4355 of 50 078 (8.7%) women in the MMS group and 5779 of 48 230 (12.0%) women in the USS group required a repeat test, and 167 (0.3%) women in the MMS group and 1894 (3.9%) women in the USS group required clinical evaluation. 97 of 50 078 (0.2%) women from the MMS group and 845 of 48 230 (1.8%) from the USS group underwent surgery. 42 (MMS) and 45 (USS) primary ovarian and tubal cancers were detected, including 28 borderline tumours (eight MMS, 20 USS). 28 (16 MMS, 12 USS) of 58 (48.3%; 95% CI 35.0-61.8) of the invasive cancers were stage I/II, with no difference (p=0.396) in stage distribution between the groups. A further 13 (five MMS, eight USS) women developed primary ovarian cancer during the year after the screen. The sensitivity, specificity, and positive-predictive values for all primary ovarian and tubal cancers were 89.4%, 99.8%, and 43.3% for MMS, and 84.9%, 98.2%, and 5.3% for USS, respectively. For primary invasive epithelial ovarian and tubal cancers, the sensitivity, specificity, and positive-predictive values were 89.5%, 99.8%, and 35.1% for MMS, and 75.0%, 98.2%, and 2.8% for USS, respectively. There was a significant difference in specificity (p<0.0001) but not sensitivity between the two screening groups for both primary ovarian and tubal cancers as well as primary epithelial invasive ovarian and tubal cancers. INTERPRETATION: The sensitivity of the MMS and USS screening strategies is encouraging. Specificity was higher in the MMS than in the USS group, resulting in lower rates of repeat testing and surgery. This in part reflects the high prevalence of benign adnexal abnormalities and the more frequent detection of borderline tumours in the USS group. The prevalence screen has established that the screening strategies are feasible. The results of ongoing screening are awaited so that the effect of screening on mortality can be determined. FUNDING: Medical Research Council, Cancer Research UK and the Department of Health, UK; with additional support from the Eve Appeal, Special Trustees of Bart's and the London, and Special Trustees of University College London Hospital.
(No abstract Available)