Psychoneurological Symptom Cluster in Oncology

NCT05867966 | Recruiting

• 1 other identifier: PNSC_onco
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Breast Cancer; Digestive Cancer

Keywords

cancer; oncology; symptoms; quality of life; hypnosis; self-care

Outcome Measures

Primary Outcomes (5)

• Change in Fatigue

  Assessed with a questionnaire (Multidimensional Fatigue Inventory; MFI-20). 5 subscales, each with a score comprised between 4 and 20, with a higher score indicating higher fatigue.

  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

  Assessed with a visual analogue scale (VAS) (score range from 0 to 10/10, a higher score indicating a higher pain) and with a questionnaire (McGill Pain Questionnaire).

  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

  Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher sleep difficulties.

  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

  Assessed with a questionnaire (FACT-Cog), investigation 4 dimensions (perceived cognitive impairments, score range 0-72, higher score indicating less impairments ; impact of cognitive impairments on quality of life, score range 0-16, with higher scoe indicating less impact ; Comments from others, score range 0-16 with higher score indicating less comments ; perceived cognitive abilities, score range 0-28, with higher score indicating more cognitive abilities)

  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

  Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher emotional distress

  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 Outcomes (5)

• Change in quality of life

  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

  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

  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

  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

  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).

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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

Control group

NO INTERVENTION

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.

Interventions

psychoeduc/self-care/self-hypnosis group BEHAVIORAL

See arm description.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Liege: lead
• Centre Hospitalier Universitaire de Liege: collaborator
• Fonds pour la Recherche Scientifique (FRS-FNRS): collaborator

Study Sites (1)

University of Liège

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Charlotte GREGOIRE, PhD

  University of Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte GREGOIRE, PhD

CONTACT

+3243662986; ch.gregoire@uliege.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: The WP1 is observational only (N = 440) In the WP2, 60 other participants will be randomized into an intervention group and a control group.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 22, 2023
• Study Start: January 16, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When all data has been collected.
• Access Criteria: by email (ch.gregoire@uliege.be)

Locations

BE (1)