The feasibility of dialogue writing with patients who have an eating disorder

This study emerged from the creation of dialogue writing, a new intervention for the treatment of eating disorders. A nascent intervention, the study investigated its feasibility as a form of treatment for eating disorders; specifically the study gathered data regarding the participant\u27s experience with dialogue writing. The dialogue writing process involves writing a dialogue between the self and the eating disorder as personified in a character created by the participant. Nine women receiving treatment for eating disorders at a clinic participated in a group setting in the dialogue writing exercise, which was administered by the groups\u27 regular facilitator. Although the exercise was presented in a group setting, the process was completed individually. After the exercise, the women completed a questionnaire with open ended questions regarding the ease or difficulty of following the instructions, their experience during the exercise and the effect, if any, it had on their relationship to their eating disorder. The findings of the research indicate the need for some alterations to the verbal instructions. Additionally, the intervention\u27s ability to aid the participant in externalizing their eating disorder became evident. Issues of power and control in participants\u27 relationships to their eating disorders emerged, as well as contradictions inherent in thought processes. Emotional responses were primarily mixed and varied for each client. The study also showed the effectiveness of the intervention in engaging participants in their own process regardless of their stage in treatment

Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP.

PURPOSE: The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007 and updated in 2021 (STEEP 2.0), provide standardized definitions of adjuvant breast cancer (BC) end points. STEEP 2.0 identified a need to separately address end points for neoadjuvant clinical trials. The multidisciplinary NeoSTEEP working group of experts was convened to critically evaluate and align neoadjuvant BC trial end points. METHODS: The NeoSTEEP working group concentrated on neoadjuvant systemic therapy end points in clinical trials with efficacy outcomes-both pathologic and time-to-event survival end points-particularly for registrational intent. Special considerations for subtypes and therapeutic approaches, imaging, nodal staging at surgery, bilateral and multifocal diseases, correlative tissue collection, and US Food and Drug Administration regulatory considerations were contemplated. RESULTS: The working group recommends a preferred definition of pathologic complete response (pCR) as the absence of residual invasive cancer in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0 per AJCC staging). Residual cancer burden should be a secondary end point to facilitate future assessment of its utility. Alternative end points are needed for hormone receptor-positive disease. Time-to-event survival end point definitions should pay particular attention to the measurement starting point. Trials should include end points originating at random assignment (event-free survival and overall survival) to capture presurgery progression and deaths as events. Secondary end points adapted from STEEP 2.0, which are defined from starting at curative-intent surgery, may also be appropriate. Specification and standardization of biopsy protocols, imaging, and pathologic nodal evaluation are also crucial. CONCLUSION: End points in addition to pCR should be selected on the basis of clinical and biologic aspects of the tumor and the therapeutic agent investigated. Consistent prespecified definitions and interventions are paramount for clinically meaningful trial results and cross-trial comparison