Clinical trial NCT05426330: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Cancer
Keywords: Cancer
Advanced Cancer Patients
Primary Caregivers
Advanced Care Planning
ACP
Communication
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
Collaborators: name: Fonds Gaston Ithier
name: Université Libre de Bruxelles
name: Association Jules Bordet
First posted: 2022-06-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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 criteria: The general eligibility criteria for patients are as follows:

* Be competent (defined according to Appelbaum et al. (1988) as the ability to understand, reason and communicate)
* Speak French
* Be over 18 years of age
* Have given written informed consent to participate in the study

In addition to these general criteria, specific eligibility criteria are defined for patients referred for medical oncology, hematology, surgery or radiotherapy.

Specific criteria for patients attending a medical oncology consultation:

* To have metastatic cancer or cancer with locoregional extension
* and be involved in a new line of treatment (ongoing or planned), following resistance of the disease to at least one first treatment;
* and/or have been diagnosed with brain metastasis.

Specific criteria for patients attending a hematology oncology consultation:

* To have a hemato-oncological condition
* and be involved in a first line of non-curative therapy (e.g. myeloma, acute myeloid leukemia on Vidaza-Venetoclax);
* and/or be involved in a new line of treatment (ongoing or planned), following a relapse of the disease after at least one first line of treatment.

Specific criteria for patients attending a surgery consultation:

* To have metastatic cancer or cancer with locoregional extension
* and be involved in the scheduling of a major surgery.

Specific criteria for patients attending a radiation therapy consultation:

* To have metastatic cancer or cancer with locoregional extension
* and be involved in a radiotherapy treatment involving more than one session

Exclusion Criteria for patients :

* 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).

Inclusion Criteria for primary Caregivers :

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

Inclusion Criteria for physicians :

* 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

Primary outcomes:
measure: Rate of willingness of patients and their primary caregiver to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Rate of patients and their primary caregiver's advanced care wishes.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: Impact of physician's communication about the patient's ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of emotional distress on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of satisfaction with cancer care on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of Intolerance of Uncertainty on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of moral principles on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of decision-making preferences regarding medical decisions on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of physicians' perceived self-efficacy to communicate about the patient's ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of physicians' perceived communication about patients' ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of physicians' outcome expectancies regarding communication about patients' ACP on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of collusion between patient, their primary caregiver and the physician(s) on patient, their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of physician cognitive empathy on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of physicians' burn out on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of relational factors on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP.
timeFrame: Baseline
measure: Impact of perceived daily burden on patients and their primary caregiver's willingness to communicate with each other and with the physician(s) about the patient's ACP
timeFrame: Baseline
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
Study officials:
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