MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

BACKGROUND: Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer. METHODS: This study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120-160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group). A process evaluation using May's Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed. DISCUSSION: There is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively help women with hot flushes and whether and how it can be translated into routine clinical practice. TRIAL REGISTRATION: ISRCTN 12824632 . Registered 25-01-2017.

Problems with measuring satisfaction with social care.

The measurement of customer satisfaction has become widespread in both healthcare and social care services, and is informative for performance monitoring and service development. Satisfaction with social care services is routinely measured with a single question on overall satisfaction with care, comprising part of the Adult Social Care Survey. The measurement of satisfaction has been problematised, and existing satisfaction measures are known to be under-theorised. In this article, the process of making an evaluation of satisfaction with social care services is first informed by a literature review of the theoretical background, and second examined through qualitative interviews conducted in 2012-2013 with 82 service users and family carers in Hampshire, Portsmouth and Southampton. Participants in this study were from white British and South Asian backgrounds, and the influence of ethnicity in the process of satisfaction evaluation is discussed. The findings show that the majority of participants selected a positive satisfaction rating even though both positive and negative experiences with services were described in their narratives. It is recommended that surveys provide opportunity for service users and family carers to elaborate on their satisfaction ratings. This addition will provide more scope for services to review their strengths and weaknesses.