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

NCT04308356 | Completed

• 2 other identifiers: APHP1904162019-A01802-55
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.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
2. 2.evaluate the subjective effects of the DDA with the patient and the investigating professionals, through qualitative approach by a clinical psychologist.
3. 3.the documentation by a physician in the medical record, of patient's care preferences/values
4. 4.the documentation by the patient of his care preference/values, either by designation of surrogate or by writing advanced directives
5. 5.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.

Conditions

Neoplasm Metastasis; Locoregional Neoplasm; Advanced Cancer

Keywords

Prospective monocentric cohort study; Mixed methodology; Dedicated Discussions on Anticipating preferences; Care; Aggravation

Outcome Measures

Primary Outcomes (1)

• Documentation by a physician of patient's care preferences/values 6 months after E2 interview

  Rate of patients for whom this documentation by a physician is found in hospital electronic medical record

  7 months

Secondary Outcomes (13)

• Patient has decided and documented his/her choice on a surrogate decision maker

  7 months

• Patient has written advanced directives

  7 months

• Patient has discussed values and care preferences with the surrogate

  7 months

• Anxiety generated by the E2 interview

  at the end of E2 (4 weeks)

• REASSURING

  at the end of E2 (4 weeks)

Interventions

Autonomy Preference Index (API ) questionnaire - Information OTHER

part of interview 1

anxiety and depression (HADS) questionnaire OTHER

part of interview 1

Dedicated Discussions on Anticipating preferences of care in the event of Aggravation (DDA) BEHAVIORAL

interview 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients population in medical care for advance cancer in oncology or pneumology, for which the aim is not the cure of the disease, but rather longer survival or quality of life maintenance, whose lifespan expectation is approximately higher than a year.

You may qualify if:

• Patients 18 years of age or older
• Followed by oncologists from the medical oncology and pulmonology departments of Cochin Hospital,
• with advanced stage cancer (solid neoplasm, any location) (locoregional or metastatic),
• whose objective of care is not curative (in the sense of healing)
• whose life expectancy is less than 1 year, estimated by the investigating physician, by the standard question, commonly used in the literature, "would you be surprised if this patient died within the next year?"

You may not qualify if:

• Severe psychopathology (generalized anxiety disorder, panic disorder, schizophrenia spectrum disorders, bipolar and related disorders, and major depressive disorders), mentioned in the patient medical record
• Persistent cognitive disorders, with type of dementia or confusion, mentioned in the patient medical record
• Patient not fluent in French
• Eastern Cooperative Oncology Group (ECOG) Performance status = 4
• A refusal of the patient after proposal and information about the study
• Patient not affiliated to a social security system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Unité Fonctionnelle de Médecine palliative, Hôpitaux Universitaire Paris Centre - CHU Cochin

Paris, 75014, France

Location

Related Publications (6)

• Sudore RL, Heyland DK, Lum HD, Rietjens JAC, Korfage IJ, Ritchie CS, Hanson LC, Meier DE, Pantilat SZ, Lorenz K, Howard M, Green MJ, Simon JE, Feuz MA, You JJ. Outcomes That Define Successful Advance Care Planning: A Delphi Panel Consensus. J Pain Symptom Manage. 2018 Feb;55(2):245-255.e8. doi: 10.1016/j.jpainsymman.2017.08.025. Epub 2017 Sep 1.

  PMID: 28865870 BACKGROUND

• Michael N, O'Callaghan C, Clayton J, Pollard A, Stepanov N, Spruyt O, Michael M, Ball D. Understanding how cancer patients actualise, relinquish, and reject advance care planning: implications for practice. Support Care Cancer. 2013 Aug;21(8):2195-205. doi: 10.1007/s00520-013-1779-6. Epub 2013 Mar 14.

  PMID: 23494583 BACKGROUND

• Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.

  PMID: 18840840 BACKGROUND

• Mack JW, Cronin A, Keating NL, Taback N, Huskamp HA, Malin JL, Earle CC, Weeks JC. Associations between end-of-life discussion characteristics and care received near death: a prospective cohort study. J Clin Oncol. 2012 Dec 10;30(35):4387-95. doi: 10.1200/JCO.2012.43.6055. Epub 2012 Nov 13.

  PMID: 23150700 BACKGROUND

• Dow LA, Matsuyama RK, Ramakrishnan V, Kuhn L, Lamont EB, Lyckholm L, Smith TJ. Paradoxes in advance care planning: the complex relationship of oncology patients, their physicians, and advance medical directives. J Clin Oncol. 2010 Jan 10;28(2):299-304. doi: 10.1200/JCO.2009.24.6397. Epub 2009 Nov 23.

  PMID: 19933909 BACKGROUND

• Maciejewski PK, Prigerson HG. Emotional numbness modifies the effect of end-of-life discussions on end-of-life care. J Pain Symptom Manage. 2013 May;45(5):841-7. doi: 10.1016/j.jpainsymman.2012.04.003. Epub 2012 Aug 25.

  PMID: 22926093 BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Isabelle COLOMBET, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: March 16, 2020
• Study Start: June 3, 2020
• Primary Completion: May 23, 2024
• Study Completion: July 7, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (1)