Cancer, AdvancedNCT04604873
The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers (HDJ-SPI)
A study testing Hospital day care follow-up in people with Cancer, Advanced, run by Institut Curie at 6 sites in France.
Trial summary
The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced
- What is being tested?
- Hospital day care follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 6 sitesFrance
- Study dates
- 28 Sep 2020to 23 Jan 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient ≥ 18 years old with advanced solid tumor
- Addressed for the first time to the palliative care team according to current criteria (medico-psycho-social symptoms, progressive risks)
- With or without anti-cancer treatment
- With estimated life expectancy of more than 2 months and less than 12 months
- Able to communicate in French and answer questionnaires
- Affiliated with a social security system
- Having signed informed consent, co-signed by the partner if designated by the patient
Who cannot join
- Patient with primitive brain tumor or malignant hemopathy
- Severe psychopathological disorders
- Pregnant patient or childbearing potential without effective method of birth control
- Unable to be followed at the cancer center until death
- Patient deprived of liberty or under guardianship -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Institut Bergonie
Bordeaux, 33076
Centre Antoine Lacassagne
Nice, 06189
Institutcurie Paris
Paris, 75005
INSTITUT CURIE Saint-Cloud
Saint-Cloud, 92210
Institut de Cancerologie de L'Ouest
Saint-Herblain, 44805
Centre Paul Strauss
Strasbourg, 67065
About this study
Official title: The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers
The main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).
- Conditions
- Cancer, Advanced
- Being tested
- Hospital day care follow-up
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital day care follow-upOther
Regular follow up every month in hospital day care
| Study group | Role | What they receive |
|---|---|---|
| No hospital one day care | No intervention | No hospital one day care |
| Hospital one day care | Other | Hospital one day care Receives: Other: Hospital day care follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer
Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer
Outcome shall be evaluated by assessing Survival without quality of life deterioration,measured by EORTC QLQ-C30 scale with monthly evaluation targeting three dimensions :
global quality of life/ fatigue/ patient emotional state
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start28 Sep 2020
- Primary completion23 Jan 2024
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer, AdvancedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604873
- Sponsor's protocol ID
- IC 2019-08
- Status last verified
- Sep 2025
- First submitted
- 20 Oct 2020
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Marret L, Anota A, Waechter L, Laouisset C, Marchal T, Burnod A, Angellier E, Djoumakh OEK, Thebaut C, Bredart A, Dolbeault S, Mino JC, Bouleuc C. Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial. BMC Palliat Care. 2021 Apr 17;20(1):61. doi: 10.1186/s12904-021-00754-x.
PubMed 33865379
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Integrated Support and Palliative in Cancer Day-care Hospital for Patients With Advanced Cancers: Impact on Quality of Life, Care Pathways and Support for Caregivers
- ClinicalTrials.gov ID
- NCT04604873
- Acronym / sponsor ID
- IC 2019-08
- Conditions
- Cancer, Advanced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 27 Oct 2020 (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 main objective is to show the impact on the quality of life (QoL) for adults patients with advanced cancer managed in day hospital of integrated palliative care of cancer center (HDJ-SPI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No hospital one day care | No intervention | –No hospital one day care |
| Hospital one day care | Other | Other: Hospital day care follow-upHospital one day care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient ≥ 18 years old with advanced solid tumor
- Addressed for the first time to the palliative care team according to current criteria (medico-psycho-social symptoms, progressive risks)
- With or without anti-cancer treatment
- With estimated life expectancy of more than 2 months and less than 12 months
- Able to communicate in French and answer questionnaires
Key exclusion criteria (5 listed)
- Patient with primitive brain tumor or malignant hemopathy
- Severe psychopathological disorders
- Pregnant patient or childbearing potential without effective method of birth control
- Unable to be followed at the cancer center until death
- Patient deprived of liberty or under guardianship -
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 |
|---|---|---|
| Hospital day care follow-upRegular follow up every month in hospital day care | Other | Hospital one day care |
Primary outcome
Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer
Time frame: 12 months
Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer Outcome shall be evaluated by assessing Survival without quality of life deterioration,measured by EORTC QLQ-C30 scale with monthly evaluation targeting three dimensions : global quality of life/ fatigue/ patient emotional state
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 Sep 2025.
- Derived from this study: PubMed 33865379Marret L, Anota A, Waechter L, Laouisset C, Marchal T, Burnod A, Angellier E, Djoumakh OEK, Thebaut C, Bredart A, Dolbeault S, Mino JC, Bouleuc C. Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial. BMC Palliat Care. 2021 Apr 17;20(1):61. doi: 10.1186/s12904-021-00754-x.
- Individual participant dataSharing planned: Yes. Investigators will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital day care follow-up in people with Cancer, Advanced, run by Institut Curie at 6 sites 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 7 inclusion and 5 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Analyse impact of hospital day care in integrated palliative care department on quality of life of adult patients with advanced stage cancer (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04604873, which also lists 1 linked publication.
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 Sep 2025.