Evaluation of a Psychoeducational intervention for patients with Advanced Cancer who have Cachexia and their lay Carers (EPACaCC): study protocol

Aim: To evaluate a psychoeducational intervention for patients with advanced cancer who have cachexia and their lay carers.

Background: Cachexia is a frequent and devastating syndrome of advanced cancer. It has an impact on patients biologically, psychologically and socially and has profound impact on their lay carers. Prior research has predominately focused on the biological components of cachexia and associated potential treatment modalities. At present, there is no standardized supportive healthcare intervention in current practice that targets the psychosocial impact of this syndrome.

Design: A pragmatic multicentre randomized controlled trial.

Methods: Patient/carer dyads (n = 200) will be recruited into a randomized controlled trial of a DVD intervention for cachexia management. The sample will be recruited from two urban hospices in the UK. The primary outcome measure will be the General Health Questionnaire-12. Additional questionnaires focusing on distress, readiness to give care and coping skills will be used as secondary outcome measures. In addition, lay carers in the intervention group will be asked to participate in semi-structured interviews following the death of their loved one. Both Office for Research Ethics Committee approval and local governance approval at both hospices have been obtained as of February 2013.

Discussion: This is the first time that a psychoeducational DVD has been tested in a randomized controlled trial in this population. Dissemination of findings will make a significant contribution to international knowledge and understanding in this area. Findings will inform education, practice and policy.

Offshoring Clinical Trials: The Mutable Ethics, Weak Protections and Vulnerable Subjects of EU Law

In this paper I engage with science and technology studies work on pharmaceuticalisation to explore how European Union (EU) law helps to produce and support the preference for pharmaceutical responses in public health governance, while authorising the production of vulnerable subjects through the growing off-shoring of clinical trials. Drawing on the analysis of legal and policy documents, I demonstrate how EU law allows and legitimates the use of data procured from vulnerable subjects abroad for market authorisation and corporate profitability at home. This is possible because the EU has (de)selected international ethical frameworks in order to support the continued and growing use of clinical trials data from abroad. This has helped to stimulate the revision of international ethical frameworks in light of market needs, inscribing EU public health law within specific politics (that often remained obscured by the joint workings of legal and technological discourses). I suggest that law operates as part of a broader ‘technology’ – encompassing ethics and human rights discourses – that functions to optimise life through resort to market reasoning. Law is thereby reoriented, instrumentalised and deployed as part of a broader project aimed at (re)defining and limiting the boundaries of the EU's responsibility for public health, including the broader social production of public health problems and the unequal global order that the EU represents and helps to depoliticise and perpetuate. Overall, this limits the EU's responsibility and accountability for these failures, as well as another: the weak and mutable protections and insecure legacies for vulnerable trial subjects abroad.

Service user and carer participation in an endoscopy nursing programme

This article reports an initiative to improve students' insight into service user and carer experience of endoscopy, particularly those with severe disability, such as spinal cord injury. This insight has the potential to improve the information provided and level of person-centred care in an endoscopy service. It was evident in the feedback from the classroom encounter that the teaching and learning strategy had a positive outcome, which will allow us to integrate the approach into future curriculum development and delivery, bringing the lived experience from the service user and carer perspective into the classroom. Students engaged in discussion and used their reflective skills to develop sensitivity to those with physical disability and complex needs requiring endoscopy procedures.

Attitudes and Ethics: Evaluating Knowledge and Regulatory Constructs in Planning Enforcement Practice

The departure point for the paper is the need to scrutinise previously unconsidered dimensions which are fundamental to understanding the dynamics of the planning enforcement system. Drawing upon emerging themes in regulation theory the paper fuses these with knowledge constructs. The rationale is that regulatory regimes must be informed by knowledge imparted from a range of sources and the resultant quality of decision making is inextricably linked to the robustness and completeness of the evidence base collated.
The theoretical analysis, coupled with proposed radical legislative changes, provides a lens for an empirical investigation which scrutinises tactics, strategies, operational mechanisms, attitudinal dimensions and ethics with a view to identifying key factors impacting upon enforcement efficacy. Prizes and pitfalls are identified in the course of the analysis and evaluation, with evidence-based remedies suggested where appropriate. The paper concludes by reflecting on the importance of theoretical synergy, epistemological advancement, taking cognisance of ethical and attitudinal challenges facing the planning profession; and, stresses the importance of identifying and bringing to book those who flagrantly breach the Code of Professional Conduct.