Effects of a Neuroscience-based Technique on Cancer Patients Announced of a Palliative Disease Progression and Partners

NCT03652298 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-03-13

No results posted yet for this study

Summary

The diagnosis and treatment trajectory of cancer can constitute a traumatic event because these can be perceived as sudden, catastrophic and life threatening. One common mental disorder following traumatic events is post-traumatic stress disorder (PTSD), described as reexperiencing of the event (e.g., having intrusive thoughts), having avoidance of trauma memories, emotional numbing, and experiencing hyperarousal symptoms. To date, and to the best of the investigator's knowledge, few studies have focused on PTSD in advanced cancer, but the existing data show that these patients are at risk for experiencing PTSD symptoms.

Among the early interventions for preventing PTSD in people confronted by traumatic events is group debriefing, the retelling of the event, receiving empathy and compassion, and being encouraged to express feelings. However, four meta-analyses found debriefing to be ineffective. A neuroscience-based and evidence-based alternative may be the Memory Structuring Intervention (MSI) that tries to shift trauma processing from a limbic, emotional and somatic level to a frontal-cortical, cognitive and verbal level of processing. The MSI tries to achieve this shift by teaching people confronted with traumatic events to chronologically organize the segments of the event, to verbally label feelings or somatic sensations rather than re-experience them, and to provide causal links between the event's segments and causality to their feelings and sensations Since in males, sympathetic responses were more predictive of PTSD than in females , parasympathetic activation may be needed to be added to the MSI, for men. A main branch of the parasympathetic response is the vagus nerve, whose non-invasive index is Heart Rate Variability (HRV). One way to increase HRV, and thus parasympathetic activation, is through vagal breathing (i.e., deep, paced breathing). Therefore, adding to the MSI deep vagal breathing (VB) to reduce sympathetic hyperactivity, may increase connectivity between the amygdala and the frontal cortex. This may also increase the emotional regulation possibly yielded by the MSI, however in both genders.

The effects of the MSI + vagal breathing on PTSD symptoms and on prognosis in advanced cancer patients receiving announcement of terminal cancer have never been investigated. Furthermore, whether reduced inflammation and increased emotional regulation may account for such effects needs to be investigated at the fundamental level. This project reflects the merging of neuroscience, psychooncology and psychoneuroimmunology for better understanding and treating cancer patients, as well as their partners.

Conditions

Interventions

OTHER

Memory structuring intervention + Vagal breathing

The MSI component will teach participants to chronologically organize the segments of their memory of the incurable diagnosis, to verbally label feelings or somatic sensations they had at that moment, and to provide causal links between the event's segments and causality to their feelings and sensations, following the protocol of Gidron et al. (2001). In the MSI part, the patient will talk, and the therapist will note the different event parts and their real timing. Each time the patient says a feeling or sensation, the therapist will ask to verbally elaborate and provide the cause of these feelings and sensations. Then, the therapist will retell the story in a chronological manner, with verbal titles and causes for feelings and sensations. Finally, the patient will be asked to retell the story in this structured manner, after being explained how to do so. vagal breathing (i.e., deep, paced breathing) is a way to increase HRV, and thus parasympathetic activation

OTHER

support and attention (usual care)

support and attention (usual care)

Sponsors & Collaborators

  • SCALab UMR CNRS 9193 Université de Lille

    collaborator UNKNOWN
  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Georges-Michel REICH, MD · Centre oscar Lambret de Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-25
Primary Completion
2019-08-27
Completion
2020-06-10

Countries

  • France

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652298 on ClinicalTrials.gov