An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial

Background: Whilst pathways relating to the early stages of stroke care have become well established, strategies for longer-term care are less developed and longer-term outcomes remain poor for many stroke survivors. New Start, a complex intervention that includes needs identification, exploration of social networks and components of problem-solving and self-management, was designed to improve stroke survivors’ quality of life by addressing unmet needs and increasing participation. It is delivered approximately 6 months post-stroke by trained staff (facilitators). We are currently undertaking a cluster randomised feasibility trial of the New Start intervention with an embedded process evaluation, which is an important component of the design and testing of complex interventions as it provides an understanding of how interventions are delivered and function in different settings. Methods/design: This mixed methods process evaluation will explore the degree to which New Start is implemented as intended, the impact of context on intervention delivery and the acceptability of the intervention for stroke survivors, their families and practitioners. It will include non-participant observation of facilitator training and intervention delivery. Interviews with stroke survivors, facilitators and other relevant staff (including administrators and managerial staff) will be undertaken. Qualitative data from interview transcripts, facilitator reflections and observational field notes will be analysed thematically alongside numerical data documenting intervention delivery collected as part of the trial. Discussion: This process evaluation will identify factors that aid and impede implementation of the New Start intervention and improve understanding of this novel approach to longer-term stroke care. Trial registration: ISRCTN Registry, ISRCTN38920246. Registered on 22 June 2016

Surgical perspectives from a prospective, nonrandomized, multicenter study of breast conserving surgery and adjuvant electronic brachytherapy for the treatment of breast cancer

<p>Abstract</p> <p>Background</p> <p>Accelerated partial breast irradiation (APBI) may be used to deliver radiation to the tumor bed post-lumpectomy in eligible patients with breast cancer. Patient and tumor characteristics as well as the lumpectomy technique can influence patient eligibility for APBI. This report describes a lumpectomy procedure and examines patient, tumor, and surgical characteristics from a prospective, multicenter study of electronic brachytherapy.</p> <p>Methods</p> <p>The study enrolled 65 patients of age 45-84 years with ductal carcinoma or ductal carcinoma in situ, and 44 patients, who met the inclusion and exclusion criteria, were treated with APBI using the Axxent^®electronic brachytherapy system following lumpectomy. The prescription dose was 34 Gy in 10 fractions over 5 days.</p> <p>Results</p> <p>The lumpectomy technique as described herein varied by site and patient characteristics. The balloon applicator was implanted by the surgeon (91%) or a radiation oncologist (9%) during or up to 61 days post-lumpectomy (mean 22 days). A lateral approach was most commonly used (59%) for insertion of the applicator followed by an incision site approach in 27% of cases, a medial approach in 5%, and an inferior approach in 7%. A trocar was used during applicator insertion in 27% of cases. Local anesthetic, sedation, both or neither were administered in 45%, 2%, 41% and 11% of cases, respectively, during applicator placement. The prescription dose was delivered in 42 of 44 treated patients.</p> <p>Conclusions</p> <p>Early stage breast cancer can be treated with breast conserving surgery and APBI using electronic brachytherapy. Treatment was well tolerated, and these early outcomes were similar to the early outcomes with iridium-based balloon brachytherapy.</p