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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604873
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : April 1, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Brief 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).

Condition or disease Intervention/treatment Phase
Cancer, Advanced Other: Hospital day care follow-up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : September 28, 2022
Estimated Study Completion Date : September 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No hospital one day care
No hospital one day care
Hospital one day care
Hospital one day care
Other: Hospital day care follow-up
Regular follow up every month in hospital day care




Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient ≥ 18 years old with advanced solid tumor
  2. Addressed for the first time to the palliative care team according to current criteria (medico-psycho-social symptoms, progressive risks)
  3. With or without anti-cancer treatment
  4. With estimated life expectancy of more than 2 months and less than 12 months
  5. Able to communicate in French and answer questionnaires
  6. Affiliated with a social security system
  7. Having signed informed consent, co-signed by the partner if designated by the patient

Exclusion Criteria:

  1. Patient with primitive brain tumor or malignant hemopathy
  2. Severe psychopathological disorders
  3. Pregnant patient or childbearing potential without effective method of birth control
  4. Unable to be followed at the cancer center until death
  5. Patient deprived of liberty or under guardianship -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604873


Locations
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France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Sophie MORIN, MD    05.56.33.33.33    s.morin@bordeaux.unicancer.fr   
Principal Investigator: Sophie MORIN, MD         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Elise GILBERT, MD    0492031596    elise.gilbert@nice.unicancer.fr   
Principal Investigator: Elise GILBERT, MD         
Institutcurie Paris Recruiting
Paris, France, 75005
Contact: CAROLE BOULEUC, MD    0144324640    carole.bouleuc@curie.fr   
Sub-Investigator: Carole BOULEUC, MD         
INSTITUT CURIE Saint-Cloud Recruiting
Saint-cloud, France, 92210
Contact: Elisabeth ANGELLIER, MD    0147112380    elisabeth.angellier@curie.fr   
Principal Investigator: Elisabeth ANGELLIER, MD         
Institut de Cancerologie de L'Ouest Recruiting
Saint-herblain, France, 44805
Contact: QUINTIN Julia, MD    0240679933    julia.quintin@ico.unicancer.fr   
Principal Investigator: QUINTIN Julia, MD         
Centre Paul Strauss Recruiting
Strasbourg, France, 67065
Contact: Véronique FRASIE, MD    0368767492    vfrasie@icans.eu   
Principal Investigator: Véronique FRASIE, MD         
Sponsors and Collaborators
Institut Curie
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04604873    
Other Study ID Numbers: IC 2019-08
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No