Viewing Study NCT05867966



Ignite Creation Date: 2024-05-06 @ 7:01 PM
Last Modification Date: 2024-10-26 @ 2:59 PM
Study NCT ID: NCT05867966
Status: RECRUITING
Last Update Posted: 2024-03-20
First Post: 2023-04-27

Brief Title: Psychoneurological Symptom Cluster in Oncology
Sponsor: University of Liege
Organization: University of Liege

Study Overview

Official Title: Evolution and Management of a Psychoneurological Symptom Cluster in Patients Who Had a Breast Cancer or a Digestive Cancer
Status: RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: A psychoneurological symptom cluster is increasingly documented in oncology It is composed of cancer-related fatigue sleep difficulties pain emotional distress and cognitive difficulties These symptoms are linked by strong but complex relationships and reinforce each other negatively impacting patients quality of life and survival The configuration of this cluster ie the relationships between the symptoms seems different according to the cancer diagnosis or moment in the cancer journey It has however been very little studied Network analysis is an innovative method that allows a deeper understanding of the interactions between these symptoms It also allows to compare patterns of clustering between distinct populations or measurement times Finally it allows to determine one core symptom in a cluster ie the one with the strongest associations with the other symptoms which could represent a target of choice for interventions aiming to improve the whole symptom cluster This innovative project has then two main goals First the investigators will assess the evolution of the psychoneurological symptom cluster in two populations of patients with cancer women with breast cancer and patients with digestive cancer over two years Second the investigators will test the feasibility and preliminary benefits of a new mind-body group intervention specifically designed to address the core symptom of the cluster determined with network analysis in each population As suggested by many authors the proposed intervention will be based on the common-sense model of self-regulation developed by Leventhal and focus on cognitive-behavioral self-care and mind-body ie hypnosis empowering strategies The aim is to assess the satisfaction of the participants regarding the intervention as well as its impact on the symptoms involved in the cluster
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None