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Spots Global Cancer Trial Database for Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)

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Trial Identification

Brief Title: Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)

Official Title: Cross-sectional, Observational Study of Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)

Study ID: NCT05426330

Conditions

Advanced Cancer

Interventions

Study Description

Brief Summary: Advanced care planning (ACP) is a major component of end-of-life care. Advanced care planning aims to (1) establish treatment and care options in the event that continuing cancer treatment is more risky than beneficial (e.g., participating in a clinical trial testing a new treatment; continuing supportive care only) and (2) establish possible treatment limitations in the event that a medical complication threatens the patient's survival without the patient's expressed wishes (e.g., transfer to an intensive care unit; resuscitation). However, cancer patients still rarely engage with their physician(s) and family in a discussion about ACP. The primary objective of the project is to conduct a cross-sectional, observational study of the willingness of advanced cancer patients and their primary caregivers to communicate about ACP with each other and with the physician(s); and their agreement/disagreement with these respective willingness. The secondary objective of the project is to assess the medical, psychological and relational factors associated with these willingness. This study will involve 300 consecutive patient- primary caregiver-physician(s) triads. For each patient and their primary caregiver, an in-depth assessment of their willingness to communicate about ACP with each other and with the physician(s) will be conducted using specific scales. The medical, psychological and relational characteristics of the included patients and their primary caregiver will also be assessed using validated questionnaires. Results of this study will enable to propose innovative interventions likely to optimize the establishment of an ACP for numerous advanced cancer patients.

Detailed Description: Advanced care planning (ACP) is a major component of end-of-life care. Advanced care planning aims to (1) establish treatment and care options in the event that continuing cancer treatment is more risky than beneficial (e.g., participating in a clinical trial testing a new treatment; continuing supportive care only) and (2) establish possible treatment limitations in the event that a medical complication threatens the patient's survival without the patient's expressed wishes (e.g., transfer to an intensive care unit; resuscitation). ACP aims to ensure that the patient receives care consistent with their personal values, life goals, and preferences. Nowadays, ACP is conceived as an iterative process of communication between patients, their families, and caregivers. However, cancer patients still rarely engage with their physician(s) and family in a discussion about ACP. There is a gap between the recommendations that communication take place between patients, their families and physician(s) regarding end-of-life care planning, and the application of this recommendation in clinical practice. This gap threatens the quality of life care as well as the adjustment of their caregivers to this phase of the disease and the grief that follows. A thorough and rigorous study of the reasons for this discrepancy has become an essential issue for the oncology of tomorrow. No studies have quantified the respective willingness of cancer patients and their primary caregivers to communicate about ACP with each other and with their physician(s). No studies have quantified the agreement/disagreement of these patients and their primary caregivers on this issue. No study has assessed the medical, psychological, and relational factors associated with these respective willingness and agreements/disagreements. This is a cross-sectional observational study. On a weekly basis, the list of eligible patients having a consultation at the Institut Jules Bordet in the medical oncology, hematology, surgery or radiotherapy departments will be provided by the Institute's IT department. An audit of the patients' medical records will be performed by the evaluator. This check will ensure that the patient meets the study's eligibility criteria. Each patient will be personally contacted by telephone by an evaluator to introduce the study and solicit their participation. During this contact, the patient will identify and provide, if desired, the contact information for their primary caregiver and the physician they designate as their primary decision-maker in the treatment and care of their cancer condition. A psycho-oncologist evaluator will conduct the assessment for all the patients, their primary caregiver and their physician. This assessment is based on an integrative model of medical, psychological and relational factors associated with the willingness of patients and their relatives to communicate about the patient's ACP. This model has allowed the development of case report forms with different questionnaires. Informed consent forms will be provided by the evaluator, due to the sensitivity of the topics addressed. The questionnaires of the patient, their primary caregiver and their physician will be administered within one month of the first contact with the patient. A simultaneous evaluation will be conducted with patients and primary caregivers. The time difference between the questionnaires of the three protagonists involved in the study will not exceed 72 hours. The completion of the questionnaire will be assisted, in person or if necessary remotely, before the consultation. The survey will be administered using the REDCAP software. The recruitment of patients, their primary caregiver and their physician will be done consecutively. This recruitment will continue until 300 patient - primary caregiver - physician triads are included in the study. The socio-demographic and medical information of the subjects for whom this evaluation could not be performed, as well as the reasons for this non-evaluation, will be recorded and archived in the study results. This is the first study to address in a observational manner the willingness of the patient and their primary caregiver to communicate about ACP, their agreement/disagreement with these respective willingness, and the associated medical and relational psychological factors. The Institut Jules Bordet provides a framework for conducting a study, the results of which will allow optimization of the process of establishing an ACP. This optimization will improve the quality of life of these patients and their families. Conducting this study will provide suggestions for interventions that may optimize the establishment of a ACP for many cancer patients.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Institut Jules Bordet, Bruxelles, , Belgium

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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