Consultation to Announce the End of Chemotherapy and Specific Treatments in an Outpatient Setting: Evaluation of the Psychological Impact and Information Exchange.

NCT05293925 | Completed

• 1 other identifier: IC2021-14
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Quality of end of life; Palliative care; Announcement of cessation of treatment

Outcome Measures

Primary Outcomes (3)

• Emotions thermometers

  It will be offered to the patient before and after the announcement of the cessation of treatment, as well as on the 7th day after the announcement of the end of anti-tumour treatments.These thermometers have a scale of 0 to 10 and will indicate the average level of distress, anxiety, depression, anger, and help needed for the past week including the current day. Higher scores mean a worse outcome

  Baseline

• Emotions thermometers

  These thermometers have a scale of 0 to 10 and will indicate the average level of distress, anxiety, depression, anger, and help needed for the past week including the current day. Higher scores mean a worse outcome

  Day 0

• Emotions thermometers

  These thermometers have a scale of 0 to 10 and will indicate the average level of distress, anxiety, depression, anger, and help needed for the past week including the current day. Higher scores mean a worse outcome

  Day 7

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale (HADS)

  Baseline

• Hospital Anxiety and Depression Scale (HADS)

  Day 7

• EORTC QLQ PATSAT-C33 (Questions 1 to 10)

  Day 7

Interventions

announcement of cessation of treatment BEHAVIORAL

The first 40 outpatients for whom an announcement to stop anti-tumour treatments is made at the Institut Curie Paris, in a conventional oncology consultation or in Palliative Care Day Hospital. Categorical variables will be described by numbers and percentages. Quantitative variables will be described by the mean, standard deviation, median of the distribution as well as the minimum, maximum and interquartile range and compared by a Student's t test or a Wilcoxon test according to the normality of the variables.

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75005, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Romain SEBAN, MD

  Instiut Curie

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 24, 2022
• Study Start: January 27, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

FR (1)