Clinical trial · Observational
Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)
Cross-sectional, Observational Study of Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- 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
- description
- 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".
- measure
- Rate of patients and their primary caregiver's advanced care wishes.
- timeFrame
- Baseline
- description
- 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".
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (16)
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- BACKGROUNDBhatt VR. Understanding patients' values and priorities in selecting cancer treatments: Developing a therapy preference scale. J Geriatr Oncol. 2019 Sep;10(5):677-679. doi: 10.1016/j.jgo.2018.11.005. Epub 2018 Nov 27. No abstract available. PMID 30501985
- BACKGROUNDBredart A, Beaudeau A, Young T, Moura De Alberquerque Melo H, Arraras JI, Friend L, Schmidt H, Tomaszewski KA, Bergenmar M, Anota A, Costantini A, Marchal F, Tomaszewska IM, Vassiliou V, Chie WC, Hureaux J, Conroy T, Ramage J, Bonnetain F, Kulis D, Aaronson NK; EORTC Quality of Life Group. The European organization for research and treatment of cancer - satisfaction with cancer care questionnaire: revision and extended application development. Psychooncology. 2017 Mar;26(3):400-404. doi: 10.1002/pon.4127. Epub 2016 Apr 13. No abstract available. PMID 27546090
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- BACKGROUNDDegner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43. PMID 9505581
- BACKGROUNDEpstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373.