- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05867966
Psychoneurological Symptom Cluster in Oncology
March 18, 2024 updated by: Audrey Vanhaudenhuyse, University of Liege
Evolution and Management of a Psychoneurological Symptom Cluster in Patients Who Had a Breast Cancer or a Digestive Cancer
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charlotte GREGOIRE, PhD
- Phone Number: +3243662986
- Email: ch.gregoire@uliege.be
Study Locations
-
-
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Liège, Belgium, 4000
- Recruiting
- University of Liège
-
Contact:
- Charlotte Grégoire, PhD
- Phone Number: +3243662986
- Email: ch.gregoire@uliege.ne
-
Principal Investigator:
- Charlotte GREGOIRE, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
These participants will benefit from an 8-week group intervention combining psychoeducation, self-care learning and hypnosis exercises.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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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
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).
|
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).
|
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
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).
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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)
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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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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).
|
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).
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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).
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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).
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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).
|
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.
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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).
|
Assessed with a questionnaire (Brief Illness Perception Questionnaire) composed of 8 VAS from 0 to 10.
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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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charlotte GREGOIRE, PhD, University of Liège
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2024
Primary Completion (Estimated)
September 30, 2025
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
April 27, 2023
First Submitted That Met QC Criteria
May 11, 2023
First Posted (Actual)
May 22, 2023
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PNSC_onco
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The full protocol and anonymized data will be available upon reasonable request by email.
IPD Sharing Time Frame
When all data has been collected.
IPD Sharing Access Criteria
by email (ch.gregoire@uliege.be)
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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