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189 active trials for Advanced Cancer

Do Patients Want to Engage in Discussions Dedicated to Anticipating (DDA) Their Preferences of Care in the Event of Worsening Health Status?

Context: In people concerned by serious illness, how to anticipate the aggravation of the disease according to the patient's preferences is a challenging clinical question and an ethical key-issue to improve end-of-life care and quality of dying in France. When end of life decision occurs, many patients can no longer express themselves and advance directives do not seem to be appropriate for many patients despite the current strong incentives to write them, reinforced by the 2016 Claeys Leonetti. The "End-of-Life Discussions" and "Advance care planning" programs developed in the United States have shown a positive impact on the aggressiveness of end-of-life care. The implementation in France of these programs has not yet been consolidated despite a first recommendation for "Planification des soins futurs", published by the French Health Authority(HAS). Inspired by the definition given in the later document, investigators propose the acronym DDA, for the Discussions Dedicated to Anticipate wishes and preferences in the event of Aggravation, defined as the dynamic and evolving process of reflection and communication between the patient, his relatives and healthcare professionals, allowing him to address his preferences and wishes regarding his care and treatment The objective of this observational study is to characterize, in a population of patients with advanced cancer, the profile of those who take up a proposal for Dedicated Discussions on Anticipating preferences of care in the event of Aggravation (DDA) and who engage in the discussion process. Secondary objectives are to evaluate the aggressiveness of end-of-life care in the group of patients who died 1 year after their inclusion, depending on their engagement in DDA occurs and whether or not their preferences are formalized; and evaluate the subjective effects of the DDA with the patient and the investigating professionals, through qualitative approach by a clinical psychologist. Method: investigators designed a mixed, quantitative and qualitative prospective, monocenter methodology to evaluate how patients take up a proposal of DDA. This proposal consists in 2 interviews: the first one is dedicated to the assessment of the patient's wishes in terms of information and participation in decision-making (API questionnaire) and to the assessment of the degree of anxiety and depression (HADS questionnaire) (E1). The second one is conducted 1 to 4 weeks later and consists in offering and initiating DDA (E2). Quantitative outcome evaluated will be: the documentation by a physician in the medical record, of patient's care preferences/values the documentation by the patient of his care preference/values, either by designation of surrogate or by writing advanced directives the usefulness and necessity of this approach, and the anxiety it generated, as perceived by the patient The qualitative assessment will be based on data collected during E1 and E2, and for 20 patients, during a clinical interview with a psychologist dedicated to collecting the patient's impressions of previous interviews. Thanks to this study investigators expect to gather some data on the desire and feelings of cancer patients to engage in a DDA process and possibly formalize their end-of-life preferences, the impact of DDAs on care pathway indicators and the psychological effect for the patient with severe disease to project himself in advance into aggravation. These expected results will provide a better understanding of the process of anticipating end-of-life situations, which is needed to improve quality of care and end-of-life conditions.

ParisStart: June 2020
Mobile-based Empathic Communication Support Program to Promote Advance Care Planning Discussion in Advanced Cancer Patients

Background: The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: palliative care recommends discussing advance care planning (ACP) when patients' estimated life expectancy is reduced from a year to months. Discussions about ACP focus on communication among patients, their caregivers, and healthcare providers to achieve cancer-related treatment and care that is consistent with the patient's preferences based on the values and goals of the patient's life. ACP can improve outcomes for patients and caregivers; however, ACP rates remain low. One reason given might be the complexity of ACP in clinical practice. A Question Prompt List (QPL) is a structured question list encouraging patients to ask their queries to physicians and promote discussion between patients and physicians during medical consultations. Our preliminary study found that face-to-face interventions by nurses or clinical psychologists using QPL about treatment and care, which is consistent with the patient's preferences based on the values and goals of the patient's life, after standard chemotherapy for patients with advanced cancer promoted more empathic communication between patients and their physicians. In recent years, however, ensuring adequate time during outpatient visits has become difficult due to increased numbers of outpatients and shortages of corresponding medical personnel. Therefore, intervention methods not restricted by location or time are needed. Thus, we developed a mobile-based empathic communication support program, including a QPL, to facilitate discussions about patients' values and goals with their physicians. Purpose: This study examined whether a mobile-based empathic communication support program, which intends to promote ACP discussions in earlier stages of advanced cancer treatment, improves the empathic communication behaviors of patients with advanced cancer and their physicians. Main contents of the intervention: Patients in the intervention group will be provided a mobile-based empathic communication support program-an application (app) on a mobile phone. The app comprises QPL (46 questions in eight categories) and questions about the patient preferred treatment and end-of-life based on the values and goals of the patient's life. After registering with the app, patients are first given a program overview and instructions for using the app. They can then proceed with the content themselves, at home or anywhere else, at any time. Between app registration and the next outpatient visit, the patient will be interviewed (by phone or in person) by a nurse or a clinical psychologist, who will help them prepare for the discussion with the physician and ask questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, patients and their physicians will be provided feedback based on the interview. Study subjects: In sum, 264 patients with advanced or recurrent cancer will be recruited, which will occur in four departments (respiratory medicine, gastroenterology, hepatobiliary medicine, and oncology) in the outpatient clinic of the National Cancer Center Hospital, Japan. Outcome measurement: The primary outcome of this trial is the Reassurance and Emotional support score of physician behavior measured using the SHARE model at the next visit after the intervention. SHARE is a conceptual communication skills model comprising 26 items and four subscales, categorized as S: Supportive environment, H: How to deliver bad news, A: Additional information, and RE: Reassurance and Emotional support. Reassurance and Emotional support assesses physicians' behavior in providing reassurance and addressing patients' emotions with empathic responses (e.g., remaining silent out of concern for patient's feelings or accepting patient's expression of emotions). The conversation between patients and the physicians will be audio-recorded, and a third person's impression of the physician's communication behavior during the outpatient consultation will be scored on a 5-point scale from 0: not applicable at all to 4: strongly applicable. Scoring is conducted by multiple raters blinded to the assignment. Raters will be trained in conversation analysis with a manual, and inter-rater and intra-rater agreements will be checked in advance. Secondary outcomes are as follows: 1) the patient-physician behavioral assessment based on the conversation analysis manual, 2) number of conversations about ACP, 3) psychological distress, 4) quality of life, 5) medical care use, 6) app use, 7) feasibility of intervention program, 8) patients' satisfaction of the consultation, 9) care goals, and 10) preferred place for future care. We chose these outcomes for their comparability with previous studies.

Tokyo, Chuo-kuStart: September 2021
A Feasibility Study of a Virtual Rehabilitation and Physical Activity Program for People With Advanced Cancer

Background: People with advanced cancer experience fatigue and loss of functioning, which often worsens as their cancer progresses. Rehabilitation programs may help to reduce fatigue and improve overall physical function. People with advanced cancer who live in rural and remote areas lack access to cancer-specific rehabilitation and exercise expertise to manage complex symptoms of high intensity. Their access to in-person services at tertiary sites are further reduced due to public health requirements for physical distancing during the severe acute respiratory syndrome coronavirus 2 pandemic. Aim: To test the feasibility of a virtual program delivered by a team of cancer-specific rehabilitation, exercise and pain and symptom experts for remote and rural patients with advanced cancer to address their symptoms, functioning and quality of life. Design: The virtual program will be tailored to the individual person, and consist of online exercise modules, online supervised interactive group class and one-to-one virtual meetings with an exercise or rehabilitation specialist and a palliative care physician. Relevance: This study will determine whether a virtual multidisciplinary rehabilitation and exercise program is feasible for people with advanced cancer. Further, it will provide insight on how fatigue and loss of functioning can best be managed for this population in remote and rural locations.

Start: October 2021