Psychoneurological Symptom Cluster in Oncology

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867966
• Other study ID #: PNSC_onco
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: University of Liege
• Contact: Charlotte GREGOIRE, PhD
• Phone: +3243662986
• Email: ch.gregoire[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer
• Digestive Cancer
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Belgium	University of Liège	Liège

Sponsors (3)

Lead Sponsor	Collaborator
University of Liege	CHU of Liège, Fonds pour la Recherche Scientifique (FRS-FNRS)

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	Change in quality of life	Assessed with a core questionnaire (EORTC) and specific modules according to the cancer diagnosis (EORTC - ANL27, BR23, CR29, HCC18, OES18, OG25, PAN26, STO22). Score range varies according to the module. Higher score indicates a higher presence of the dimension investigated.	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	Change in self-compassion	Assessed with a questionnaire (Self-compassion scale). Score range from 26 to 130, with higher score indicating higher 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).
Secondary	Change in self-care strategies	Assessed with a questionnaire (self-care survey) consisting of a list of 24 strategies. For each of them, the participant indicates its frequency of use (occasionally, fairly often, very often) and its effectiveness to relieve fatigue (occasionally, fairly often, very often).	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	Change in coping strategies	Assessed with a questionnaire (ways of coping checklist). Divided into 3 dimensions (i.e., problem-oriented coping, emotion-oriented coping, research of social support) with score ranging from 9 to 36. Higher score indicates a higher use of this kind of coping.	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	Change in perception about their fatigue	Assessed with a questionnaire (Brief Illness Perception Questionnaire) composed of 8 VAS from 0 to 10.	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).