RecruitingNot ApplicableNCT05867966

Psychoneurological Symptom Cluster in Oncology

Evolution and Management of a Psychoneurological Symptom Cluster in Patients Who Had a Breast Cancer or a Digestive Cancer


Sponsor

University of Liege

Enrollment

500 participants

Start Date

Jan 16, 2024

Study Type

INTERVENTIONAL

Conditions

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 (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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at a cluster of symptoms — fatigue, sleep problems, anxiety, depression, and cognitive difficulties — that often occur together in cancer survivors. Researchers want to understand how and why these symptoms group together in people who have finished cancer treatment. **You may be eligible if...** - You have been diagnosed with non-metastatic breast cancer or a digestive cancer (such as colorectal, gastric, pancreatic, or liver cancer) - You are 18 or older - You have completed your active cancer treatments (surgery, chemotherapy, radiotherapy) within the last 5 years - This is your first cancer diagnosis and you are not in relapse **You may NOT be eligible if...** - You have a history of severe psychiatric illness (for some parts of the study) - Your cancer has spread to other parts of the body - You have had a previous cancer diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALpsychoeduc/self-care/self-hypnosis group

See arm description.


Locations(1)

University of Liège

Liège, Belgium

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NCT05867966


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