Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05867966

Psychoneurological Symptom Cluster in Oncology

Led by University of Liege · Updated on 2025-03-21

500

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

U

University of Liege

Lead Sponsor

C

Centre Hospitalier Universitaire de Liege

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 (i.e., 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 (i.e., 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 (i.e., 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.

CONDITIONS

Official Title

Psychoneurological Symptom Cluster in Oncology

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of non-metastatic breast cancer or digestive cancer (anal, colorectal, gastric, esophageal, liver, pancreatic cancers)
  • Age 18 years or older
  • No history of cancer and not in relapse
  • Completed active cancer treatments (surgery, chemotherapy, radiotherapy) within the past 5 years
  • No history of severe psychiatric disorders or substance abuse (for intervention group)
  • Score of 4 or higher on the core symptom measured on a 0 to 10 scale (for intervention group)
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Liège

Liège, Belgium, 4000

Actively Recruiting

Loading map...

Research Team

C

Charlotte GREGOIRE, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here