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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04604873
Other study ID # IC 2019-08
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 28, 2020
Est. completion date January 23, 2025

Study information

Verified date February 2024
Source Institut Curie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 144
Est. completion date January 23, 2025
Est. primary completion date January 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Hospital day care follow-up
Regular follow up every month in hospital day care

Locations

Country Name City State
France Institut Bergonie Bordeaux
France Centre Antoine Lacassagne Nice
France Institutcurie Paris Paris
France INSTITUT CURIE Saint-Cloud Saint-cloud
France Institut de Cancerologie de L'Ouest Saint-herblain
France Centre Paul Strauss Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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