Clinical trial NCT05293925: Consultation to Announce the End of Chemotherapy and Specific Treatments in an Outpatient Setting: Evaluation of the Psychological Impact and Information Exchange.
Official title: Consultation d'Annonce d'Arrêt de la Chimiothérapie et Des Traitements Spécifiques en Contexte Ambulatoire: évaluation de l'Impact Psychologique et Des échanges d'Informations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Quality of end of life
Palliative care
Announcement of cessation of treatment
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronological inclusion of the first 40 outpatients for whom an announcement to stop anti-tumour treatments was made at the Institut Curie Paris, in a conventional oncology consultation or in a Palliative Care Day Hospital

Brief summary: The average 5-year survival rate for patients diagnosed with cancer in France is estimated at 53%. Nearly half of all patients diagnosed with cancer are not alive 5 years after diagnosis Discontinuation of anti-tumor treatments is therefore a major issue in their care. Discussing the discontinuation of specific treatments requires scientific oncological skills but also communication skills. The difficulties encountered by oncologists concerning communication about the end of life are linked to the doctors' personal discomfort with death, their fear of the responsibility of stopping chemotherapy, and their distrust of their colleagues. On the other hand, they may also come from patients who are supposedly reluctant to talk about the end of life, a reluctance that is heightened in the case of language barriers, young age or pressure from families. Finally, the place of practice could explain some of the difficulties in talking about the end of life, notably because of a lack of training in delivering bad news or a stigma attached to palliative care.

This exploratory work should make it possible to describe the characteristics of the announcement of the cessation of anti-tumor treatments in ambulatory patients, to evaluate distress, anxiety, depressive symptomatology, as well as the satisfaction of the patients concerning the management received.

Detailed description: In this pilot study, we will describe for the first time the discontinuation of anti-tumour treatments in outpatients with advanced cancer and evaluate the psychological impact on patients following this announcement.

In outpatients patients, these announcements of treatment cessation will be made in a conventional oncology consultation or in Palliative Care Day Hospital.

This exploratory work should make it possible to describe the characteristics of the announcement of the cessation of anti-tumour treatments in ambulatory patients, to assess distress, anxiety, and the depressive symptomatology, as well as patient satisfaction with the treatment received.

The 2 hypotheses of this research work are the following:

1. the announcement of the cessation of specific treatments can generate distress, anxiety and depressive symptoms for the patient, and may be a source of dissatisfaction with the quality of care received.
2. the existence of an improvement in the quality of the announcement when it is made in HDJ SP in comparison with an announcement made in a conventional oncology consultation; reduction of the psychological impact for the patient, reduction in markers of aggressiveness of care at the end of end of life care. The doctors involved in this project have received training in listening to and supporting patients with advanced cancer in a palliative situation.

Eligibility criteria: Inclusion Criteria:

* Major outpatients with advanced cancer for whom anti-tumour treatment is announced by the oncologist in a conventional oncology consultation or in Palliative Care Day Hospital.
* Patient who speaks and understands the French language.
* Patient over 18 years of age.
* Patient informed and not opposed.

Exclusion Criteria:

* Refusal of the patient or doctor to participate in the study.
* Patient does not speak or understand the French language.
* Patient under 18 years of age.
* Persons deprived of liberty or under guardianship (including curatorship).
* Persons of legal age under court protection.
* Inability to participate in the study for geographical, social or psychological psychological reasons.

Primary outcomes:
measure: Emotions thermometers
timeFrame: Baseline
measure: Emotions thermometers
timeFrame: Day 0
measure: Emotions thermometers
timeFrame: Day 7
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 7
measure: EORTC QLQ PATSAT-C33 (Questions 1 to 10)
timeFrame: Day 7
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Instiut Curie
name: Romain SEBAN, MD
role: PRINCIPAL_INVESTIGATOR
References: