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

NCT05426330 | Unknown

• 1 other identifier: CE3353
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Cancer

Keywords

Cancer; Advanced Cancer Patients; Primary Caregivers; Advanced Care Planning; ACP; Communication

Outcome Measures

Primary Outcomes (4)

• Rate of willingness of patients and their primary caregiver to communicate with each other and with the physician(s) about the patient's ACP.

  Willingness to communicate about patients' ACP is assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Willingness to communicate about the patient's ACP". The questionnaire is composed of 8 items regarding the willingness to communicate with each other and with the physician(s) about patients' planification of treatments, care, and the patient's prognosis. Each item has a 4 points Likert scale, ranging from "no" to "yes".

  Baseline

• Rate of patients and their primary caregiver's advanced care wishes.

  Advanced care wishes are assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "advanced care wishes". The questionnaire is composed of 12 items regarding advanced care preferences: participating in a clinical trial, receiving supportive care only, being resuscitated, being transferred to an intensive care unit. Each item has a 4 points Likert scale ranging from "no" to "yes".

  Baseline

• Rate of patients and their primary caregiver's perceived self-efficacy to communicate with each other and with the physician(s) about the patient's ACP.

  Perceived self-efficacy to communicate about the patient's ACP is assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Perceived self-efficacy to communicate about the patient's ACP ". The questionnaire is composed of 4 items regarding the patient's and primary caregiver's perception of their efficacy to communicate with each other and with the physician(s) about patient's planification of treatments and care. Each item has a 4 points Likert scale ranging from "no" to "yes".

  Baseline

• Rate of patients and their primary caregiver's barriers that prevent them from communicating with each other and with the physician(s) about the patient's ACP.

  Barriers that prevent from communicating about the patient's ACP are assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Barriers that prevent from communicating about the patient's ACP". The questionnaire is composed of 14 items regarding the potential barriers that prevent the patients and their primary caregiver from communicating with each other and with the physician(s) about the patient's planification of treatments and care: physical and/or psychological health, religious and/or philosophical beliefs, lack of time and/or availability of the physician(s). Each item has a 4 points Likert scale ranging from "no" to "yes".

  Baseline

Secondary Outcomes (19)

• Impact of patients and their primary caregiver's socio-demographic characteristics on their willingness to communicate with each other and with the physician(s) about the patient's ACP.

  Baseline

• Impact of the physician's socio-professional characteristics on patients' and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.

  Baseline

• Impact of patient's current functional status on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.

  Baseline

• Impact of medical factors on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.

  Baseline

• Impact of perception of the patient's medical situation on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.

  Baseline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced cancer who have a consultation at the Institut Jules Bordet in the medical oncology, hematology, surgery or radiotherapy departments.

You may not qualify if:

• Not being competent (defined according to Appelbaum et al. (1988) as the ability to understand, reason and communicate)
• Have a poor command of the French language
• Already have a therapeutic limitation status, limited to supportive care (BSC status).
• The eligibility criteria for primary caregivers are as follows:
• Have been identified by the patient as the person who supports them the most with their cancer condition
• Be competent
• Speak French
• Be over 18 years of age
• Have given written informed consent to participate in the study
• Have been designated by the patient as the physician with whom they wish to make major decisions in terms of treatment planning and/or therapeutic limitations
• Speak French
• Have given written informed consent to participate in the study

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Fonds Gaston Ithier: collaborator
• Université Libre de Bruxelles: collaborator
• Association Jules Bordet: collaborator

Study Sites (1)

Institut Jules Bordet

Brussels, Belgium

RECRUITING

Related Publications (16)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Neoplasms; Communication

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Yves Libert, Ph.D

CONTACT

003225413415; yves.libert@bordet.be

Lisa Choucroun, M.A.

CONTACT

0032492314421; lisa.choucroun@bordet.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: June 22, 2022
• Study Start: October 4, 2021
• Primary Completion: October 4, 2023
• Study Completion: October 4, 2024
• Last Updated: June 22, 2022

Record last verified: 2022-04

Locations

BE (1)