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Trial Title:
Psychoneurological Symptom Cluster in Oncology
NCT ID:
NCT05867966
Condition:
Cancer
Breast Cancer
Digestive Cancer
Conditions: Official terms:
Breast Neoplasms
Syndrome
Conditions: Keywords:
cancer
oncology
symptoms
quality of life
hypnosis
self-care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The WP1 is observational only (N = 440) In the WP2, 60 other participants will be
randomized into an intervention group and a control group.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
psychoeduc/self-care/self-hypnosis group
Description:
See arm description.
Arm group label:
Intervention group
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Liège
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Charlotte Grégoire, PhD
Phone:
+3243662986
Email:
ch.gregoire@uliege.ne
Investigator:
Last name:
Charlotte GREGOIRE, PhD
Email:
Principal Investigator
Start date:
January 16, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
University of Liege
Agency class:
Other
Collaborator:
Agency:
CHU of Liège
Agency class:
Other
Collaborator:
Agency:
Fonds pour la Recherche Scientifique (FRS-FNRS)
Agency class:
Other
Source:
University of Liege
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05867966
