NCT03652298: NeuroPrevPTSD

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

Terminated Phase 2 Last updated 13 March 2026

What this trial tests

Phase 2 trial testing Memory structuring intervention + Vagal breathing in Colorectal Cancer in 19 participants. Terminated before completion.

Timeline

25 July 2018

Primary endpoint
27 August 2019

10 June 2020

Quick facts

Lead sponsor	Centre Oscar Lambret
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	19
Start date	25 July 2018
Primary completion	27 August 2019
Estimated completion	10 June 2020
Sites	1 location across France

Drugs / interventions tested

• Memory structuring intervention + Vagal breathing
• support and attention (usual care)

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Bladder Cancer — all drugs for Bladder Cancer →
• Prostate Cancer — all drugs for Prostate Cancer →
• Kidney Cancer — all drugs for Kidney Cancer →

Sponsor

Centre Oscar Lambret — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer or Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multiple session early psychological interventions for the prevention of post-traumatic stress disorder.
   Roberts NP, Kitchiner NJ, Kenardy J, Robertson L, et al · · 2019 · cited 33× · PMID 31425615 · DOI 10.1002/14651858.cd006869.pub3