Psychoneurological Symptom Cluster in Oncology

Official title

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

Overview

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.

Interventions

• Behavioral psychoeduc/self-care/self-hypnosis group
  See arm description.

Primary outcome measures

• Change in Fatigue [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in pain [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in sleep difficulties [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in perceived cognitive difficulties [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in emotional distress [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]

Secondary outcome measures (5)

• Change in quality of life [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in self-compassion [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in self-care strategies [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in coping strategies [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]
• Change in perception about their fatigue [Time frame: WP1 : at inclusion (T0), then 6 months (T1), 12 months (T2) and 24 months (T3) later. WP2 : at inclusion (T0), then after the group sessions (T1, +- 2 months after T0).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Belgium · 1 center

• University of Liège — Liège

Publications

• Gregoire C, Baussard L, Ernst M, Diep A, Faymonville ME, Devos M, Jerusalem G, Vanhaudenhuyse A. Evaluation of a psychoneurological symptom cluster in patients with breast or digestive cancer: a longitudinal observational study. BMC Cancer. 2024 Jan 9;24(1):51. doi: 10.1186/s12885-023-11799-x. PMID 38195471

Identifiers

NCT: NCT05867966 · PNSC_onco

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗