This study is the first large prospective RCT of sentinel node biopsy (SNB) compared with standard axillary treatment (level I-III axillary lymph node dissection or four node sampling), which includes comprehensive and repeated quality of life (QOL) assessments over 18 months. Patients (n = 829) completed the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the Spielberger State/Trait Anxiety Inventory (STAI) at baseline (pre-surgery) and at 1, 3, 6, 12, and 18 months post-surgery. There were significant differences between treatment groups favouring the SNB group throughout the 18 months assessment. Patients in the standard treatment group showed a greater decline in Trial Outcome Index (TOI) scores (physical well-being, functional well-being and breast cancer concerns subscales in FACT-B+4) and recovered more slowly than patients in the SNB group (p < 0.01). The change in total FACT-B+4 scores (measuring global QOL) closely resembled the TOI results. 18 months post-surgery approximately twice as many patients in the standard group compared with the SNB group reported substantial arm swelling (14% versus 7%) (p = 0.002) or numbness (19% versus 8.7%) (p < 0.001). Despite the uncertainty about undergoing a relatively new procedure and the possible need for further surgery, there was no evidence of increased anxiety amongst patients randomised to SNB (p > 0.05). For 6 months post-surgery younger patients reported less favourable QOL scores (p < 0.001) and greater levels of anxiety (p < 0.01). In view of the benefits regarding arm functioning and quality of life, the data from this randomised study support the use of SNB in patients with clinically node negative breast cancer.
These data indicate that fundamental components of communication and information sharing about phase I trial participation are often missing from interviews. Important omissions included discussion of prognosis and ensuring patient understanding about supportive care. These findings will inform educational initiatives to assist communication about phase I trials.
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.
Objective To evaluate a training intervention aimed at improving healthcare professionals' communication with cancer patients about randomised clinical trials. Design Before and after evaluation of training programme. Setting Members of the National Cancer Research Network, Scottish Trials Network, and the Welsh Cancer Trials Network Participants 101 healthcare professionals (33 clinicians and 68 research nurses). Intervention Four modules delivered by a trained facilitator using videotapes and interactive exercises to cover general issues about discussing randomised clinical trials with patients, problems specific to adjuvant trials, trials with palliation as the goal, and trials where patients had a strong preference for one treatment arm. Main outcome measures Before and after the intervention, participants were videotaped discussing a trial with an actor portraying a patient. These consultations were assessed for presence of information required by good clinical practice guidelines. The actor patients gave an assessment after each interview. Participants reported their self confidence about key aspects of trial discussion. Results Analysis of the videotaped consultations showed that, after intervention, significantly more participants displayed key communication behaviours such as explaining randomisation (69 v 81, odds ratio 2.33, P = 0.033), checking patients' understanding (11 v 31, odds ratio 3.22, P = 0.002), and discussing standard treatment (73 v 88, odds ratio 4.75, P = 0.005) and side effects (69 v 85, odds ratio 3.29, P = 0.006). Participants' self confidence increased significantly (P < 0.001) across all areas. Actor patients' ratings of participants' communication showed significant improvements for 12/15 key items. Conclusion This intensive 8 hour intervention significantly improved participants' confidence and competence when communicating about randomised clinical trials.
The majority of breast cancer patients preferred hormone therapy via daily tablets rather than monthly injections. Information about side-effects or improved efficacy altered these preferences. Adherence to treatment cannot be assumed; patients' preferences about drug administration may influence this.
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