Background Since 2016, France is the only country in the World where continuous deep sedation until death (CDSUD) is regulated by law. CDSUD serves as a response to refractory suffering in palliative situations where the patients’ death is expected to occur in the following hours or days. Little is known on the psychological adjustment surrounding a CDSUD procedure for healthcare providers (HCPs) and relatives. Our study aims to gather qualitative and quantitative data on the specific processes behind the psychological adjustment of both relatives and HCPs, after the administration of CDSUD for patients with cancer. Methods The APSY-SED study is a prospective, longitudinal, mixed-methods and multicenter study. Recruitment will involve any French-speaking adult cancer patient for who a CDSUD is discussed, their relatives and HCPs. We plan to include 150 patients, 150 relatives, and 50 HCPs. The evaluation criteria of this research are: 1/ Primary criterion: Psychological adjustment of relatives and HCPs 6 and 13 months after the death of the patient with cancer (psychological adjustment = intensity of anxiety, depression and grief reactions, CDSUD-related distress, job satisfaction, Professional Stress and Professional experience). Secondary criteria: a)occurrence of wish for a CDSUD in patients in palliative phase; b)occurrence of wish for hastened death in patients in palliative phase; c)potential predictors of adjustment assessed after the discussion concerning CDSUD as an option and before the setting of the CDSUD; d) Thematic analysis and narrative account of meaning-making process concerning the grief experience. Discussion The APSY-SED study will be the first to investigate the psychological adjustment of HCPs and relatives in the context of a CDSUD procedure implemented according to French law. Gathering data on the grief process for relatives can help understand bereavement after CDSUD, and participate in the elaboration of specific tailored interventions to support HCPs and relatives. Empirical findings on CDSUD among patients with cancer in France could be compared with existing data in other countries and with results related to other medical fields where CDSUD is also conducted. Trial registration This protocol received the National Registration Number: ID-RCB2021-A03042-39 on 14/12/2021.
Background and Objectives: Despite the proven benefits on reducing time to recurrence and improving survival, recent studies indicate that only half or less of patients with early stage breast cancer (BC) complete their recommended full-course of adjuvant ET. Findings suggested that adherence therefore remains a challenge for both patients and professionals, with differences in representations that remain poorly understood. The main objective of this study is to investigate BC patient’s perceptions about ET. Secondary objectives are: (1): to capture potential gaps between their perceptions and the representations of their HCP (2): to explore preferences in patients regarding programs aimed to improve adherence to ET. Methods We conducted separately focus groups with patients and HCP to capture a multilevel framework regarding non-adherence. Inclusion criteria for patients’ focus groups were: non metastatic hormone-receptor positive (HR+) BC; ≥18 years old; premenopausal at time of diagnosis; receiving ET for at least 2 months; for HCP criteria were: to be a medical oncologist, radiation oncologist, pharmacist or nurse; with at least 5 years of experience on BC. The discussion schedule was non-directive and included: introduction remarks and three key- questions linked to our objectives as well as follow-up questions to facilitate the discourse. Discussions were audio recorded, anonymized and transcribed verbatim. We used a thematic analysis approach to identify patterns and themes. Results: Twenty-eight patients (median age=45 yrs) and 17 professionals (11 women, median professional experience with BC =9.5 yrs) participated. Major themes emerging among participants are showed in Table 1. Important differences between HCP and patients with BC were analyzed regarding their representations towards adherence and communication.Conclusions: Dissatisfaction concerning ET medical monitoring and communication is shared by patients and professionals. The HCP reported a lack of communication skills to support patients struggling with ET adherence. Strikingly, the major barrier to ET reported by patients is related to the employment and the lack of adaptation to sequelae of ET. This barrier is not reported by professionals and appears a critical challenge to face. The suggestions made by patients during the focus groups offer promising perspectives regarding support programs to improve adherence. PatientsN=28Major themesSub-themes•Representations on ET : a multidimensional burden1.Side effects and management2.Benefit/risk balance 3.Seeking information on ET•Professional life1.Work reintegration2.Lack of empathy of coworkers3.Career change•Psychological adjustment to ET1.Daily struggling2.Self-image modifications3.Feelings of loneliness•Relations to health care providers1.Communication: negative and positive aspects2.Shared decision-making 3.Advice on follow-up careHCP (N=17)•Representations on ET : a therapeutic weapon1.Side effects 2.Impact on body image 3.Finding solutions regarding ET side effects•Discourse to patients1.Negotiating the adherence to treatment 2.Beliefs on patients’ suggestibility 3.Communication techniques•Emotional experience: negative impact of prescribing ET1.Emotional fatigue2.Guilt 3.Desire on having psychologists to handle the patients’ emotions•Difficulties related to the healthcare system1.Lack of time 2.Lack of training Citation Format: Léonor Maria Fasse, Nicolas Roche, Diane Boinon, Gwenn Menvielle, Agnes Dumas, Sofia Rivera, Margarida Matias, Antonio Di-Meglio, Suzette Delaloge, Ines Vaz-Luis, Barbara Pistilli. Focus on non-adherence: A qualitative exploration of perceptions associated to adjuvant endocrine therapy (ET) in premenopausal patients with breast cancer and their health care providers (HCP) [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-09-05.
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