Thinking of joining a study?

Register your interest

NCT05867966 | Recruiting | Cancer


Psychoneurological Symptom Cluster in Oncology
Sponsor:

University of Liege

Information provided by (Responsible Party):

Audrey Vanhaudenhuyse

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 (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.

Condition or disease

Cancer

Breast Cancer

Digestive Cancer

Intervention/treatment

psychoeduc/self-care/self-hypnosis group

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 500 participants
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evolution and Management of a Psychoneurological Symptom Cluster in Patients Who Had a Breast Cancer or a Digestive Cancer
Actual Study Start Date : January 16, 2024
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 31, 2027
Arm Intervention/treatment

Experimental: Intervention group

These participants will benefit from an 8-week group intervention combining psychoeducation, self-care learning and hypnosis exercises.

No Intervention: Control group

These participants will not benefit from any intervention. After the end of the study, they will have the possibility to participate in the group intervention if they want to.

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion critera for WP1
  • Diagnosis of non-metastatic breast cancer, or digestive cancer (i.e., anal, colorectal, gastric, esophageal, liver, pancreatic cancers).
  • ≥ 18 years old.
  • No history of cancer, and not currently in relapse.
  • Having completed the active treatments (i.e., surgery, chemotherapy, radiotherapy) for 5 years maximum, based on the methodology and recommendations of studies on symptom clusters in oncology
  • Additional inclusion criteria for WP2
    • No history of severe psychiatric disorders (e.g., schizophrenia, dissociative episodes) or substance abuse (to avoid severe dissociation during hypnosis).
    • Score ≥ 4 for the core symptom selected to design the intervention, as suggest by previous interventional studies, and measured on a visual analogue scale from 0 to 10.

Psychoneurological Symptom Cluster in Oncology

Location Details


Please Choose a site



Psychoneurological Symptom Cluster in Oncology

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Belgium,

University of Liège

Liège, Belgium, 4000

Loading...