Psychoneurological Symptom Cluster in Oncology

University of Liege

Status: Enrolling

Conditions: Breast Cancer; Digestive Cancer; Cancer

Treatments: Behavioral: psychoeduc/self-care/self-hypnosis group

Study type: Interventional

Funder types: Other

Identifiers

NCT05867966

PNSC_onco

Details and patient eligibility

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Behavioral: psychoeduc/self-care/self-hypnosis group

Control group

No Intervention group

Description:

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.