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Completed

NCT Number: NCT05293925

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–125 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Curie

Paris, 75005, France

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Emotions thermometers

    Time frame: Baseline

    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

  2. Emotions thermometers

    Time frame: Day 0

    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

  3. Emotions thermometers

    Time frame: Day 7

    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

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline

    The HAD is a 14-item questionnaire, with two 7-item subscales, assessing anxiety and depression respectively. Each item is scored from 0 to 3, for a total score of 21 per subscale and 42 for the total HADS. Thus a high total score correlates with a high intensity of anxiety and depression

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Day 7

    The HAD is a 14-item questionnaire, with two 7-item subscales, assessing anxiety and depression respectively. Each item is scored from 0 to 3, for a total score of 21 per subscale and 42 for the total HADS. Thus a high total score correlates with a high intensity of anxiety and depression

  3. EORTC QLQ PATSAT-C33 (Questions 1 to 10)

    Time frame: Day 7

    This questionnaire explores the area of care provided by physicians. The doctor section comprises three sub-domains addressing technical skills (3 items), information exchange (3 items), and affective behaviour (4 items). Each item is scored from 1 to 5. Higher scores mean a better outcome

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study 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.

Acronym: CACTuS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2022
Registry last updated
Dec 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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