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 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).

Study Overview

• Status: Completed
• Conditions: Cancer, Advanced
• Intervention / Treatment: Other: Hospital day care follow-up

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Institut Bergonié
  • Nice, France, 06189
    • Centre Antoine Lacassagne
  • Paris, France, 75005
    • Institutcurie Paris
  • Saint-Cloud, France, 92210
    • Institut Curie Saint-Cloud
  • Saint-Herblain, France, 44805
    • Institut de Cancérologie de l'Ouest
  • Strasbourg, France, 67065
    • Centre Paul Strauss

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No hospital one day care
Other: Hospital one day care	Other: Hospital day care follow-up; Regular follow up every month in hospital day care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Collaborators and Investigators

• Sponsor: Institut Curie

Publications and helpful links

General Publications

• Thery 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IC 2019-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific reserach, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No