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Psychoneurological Symptom Cluster in Oncology

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ClinicalTrials.gov Identifier: NCT05867966
Recruitment Status : Recruiting
First Posted : May 22, 2023
Last Update Posted : March 20, 2024
Sponsor:
Collaborators:
CHU of Liège
Fonds pour la Recherche Scientifique (FRS-FNRS)
Information provided by (Responsible Party):
Audrey Vanhaudenhuyse, University of Liege

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Breast Cancer Digestive Cancer Behavioral: psychoeduc/self-care/self-hypnosis group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evolution and Management of a Psychoneurological Symptom Cluster in Patients Who Had a Breast Cancer or a Digestive Cancer
Actual Study Start Date : January 16, 2024
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
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
See arm description.
No Intervention: Control group
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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). ]
    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.

  2. 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). ]
    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).

  3. 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). ]
    Assessed with a questionnaire (Insomnia Severity Index; ISI). Score range from 0 to 28, with a higher score indicating higher sleep difficulties.

  4. 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). ]
    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)

  5. 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). ]
    Assessed with a questionnaire (Hospital Anxiety and Depression Scale; HADS). Score range from 0 to 42, with a higher score indicating higher emotional distress


Secondary Outcome Measures :
  1. 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). ]
    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.

  2. 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). ]
    Assessed with a questionnaire (Self-compassion scale). Score range from 26 to 130, with higher score indicating higher self-compassion.

  3. 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). ]
    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).

  4. 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). ]
    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.

  5. 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). ]
    Assessed with a questionnaire (Brief Illness Perception Questionnaire) composed of 8 VAS from 0 to 10.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05867966


Contacts
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Contact: Charlotte GREGOIRE, PhD +3243662986 ch.gregoire@uliege.be

Locations
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Belgium
University of Liège Recruiting
Liège, Belgium, 4000
Contact: Charlotte Grégoire, PhD    +3243662986    ch.gregoire@uliege.ne   
Principal Investigator: Charlotte GREGOIRE, PhD         
Sponsors and Collaborators
University of Liege
CHU of Liège
Fonds pour la Recherche Scientifique (FRS-FNRS)
Investigators
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Principal Investigator: Charlotte GREGOIRE, PhD University of Liege
More Information
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Responsible Party: Audrey Vanhaudenhuyse, PhD, University of Liege
ClinicalTrials.gov Identifier: NCT05867966    
Other Study ID Numbers: PNSC_onco
First Posted: May 22, 2023    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The full protocol and anonymized data will be available upon reasonable request by email.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: When all data has been collected.
Access Criteria: by email (ch.gregoire@uliege.be)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Audrey Vanhaudenhuyse, University of Liege:
cancer
oncology
symptoms
 quality of life
hypnosis
self-care
Additional relevant MeSH terms:
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Breast Neoplasms
Syndrome
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Disease
Pathologic Processes