CancerCACTuSNCT05293925
Consultation to Announce the End of Chemotherapy and Specific Treatments in an Outpatient Setting: Evaluation of the Psychological Impact and Information Exchange.
An observational study of Cancer, run by Institut Curie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Cancer
- What is being tested?
- announcement of cessation of treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2022to 25 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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:
- 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.
- Conditions
- Cancer
- Being tested
- announcement of cessation of treatment
- Keywords
- Quality of end of life, Palliative care, Announcement of cessation of treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
announcement of cessation of treatmentBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 7
Secondary outcomes (3)
Hospital Anxiety and Depression Scale (HADS)
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
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)
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
Measured: Day 7
EORTC QLQ PATSAT-C33 (Questions 1 to 10)
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
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start27 Jan 2022
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain SEBAN, MD, Principal investigator, Instiut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293925
- Sponsor's protocol ID
- IC2021-14
- Acronym
- CACTuS
- Status last verified
- Dec 2023
- First submitted
- 25 Feb 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05293925
- Acronym / sponsor ID
- CACTuS / IC2021-14
- Conditions
- Cancer
- Keywords
- Quality of end of life, Palliative care, Announcement of cessation of treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| announcement of cessation of treatmentThe 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. | Behavioural | – |
Primary outcome
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
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
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
3 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 7
EORTC QLQ PATSAT-C33 (Questions 1 to 10)
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain SEBAN, MD principal investigator
Instiut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotions thermometers (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.