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

NCT03652298 | Terminated Phase 2

• 2 other identifiers: NeuroPrevPTSD-18042018-A00656-49
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer; Bladder Cancer; Prostate Cancer; Kidney Cancer; Advanced Sarcoma

Keywords

PTSD; Memory Structuring Intervention (MSI); Cancer; Vagal breathing

Outcome Measures

Primary Outcomes (1)

• PCL-5 score measurement at at 3 months (+/- 2 weeks) by the patient

  PCL-5 means PTSD Checklist for DSM-5. This self-report rating scale assesses the presence and severity of PTSD symptoms. It includes 20 items. Each item is rated on a 0 (not at all) to 4 (extremely) response scale. The total score (0-80) is obtained by summing the scores for each of the 20 items. This total score reflects the severity of PTSD symptoms, and a cut-off of 32 reflects probable PTSD.

  3 months

Secondary Outcomes (10)

• Evolution of PCL-5 score in the first 3 months in the patient

  3 months

• The quality of life (QoL) score of the patient: EQ-5D

  3 months

• Quality-adjusted life years (QALY) of the patient

  3 months

• Inflammation level in the patients

  3 months

• Emotion regulation in the patients

  3 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

In the experimental group, participants will perform vagal breathing (VB), followed by the MSI, followed again by VB. The VB component will guide participants how to perform deep slow vagal breathing by inhaling and counting 1-5, holding their breath and counting 1-2, and exhaling and counting 1-5, during 2-5 minutes. 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).

Other: Memory structuring intervention + Vagal breathing

Control Arm

OTHER

Participants in the control group will receive support and attention (usual care) and will be invited to recall announcement of the incurable disease progression. More precisely, they will be invited to express their associated thoughts and feelings, being free to talk about their experience, and the psychologist will react with empathy and support.

Other: support and attention (usual care)

Interventions

Memory structuring intervention + Vagal breathing OTHER

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

Experimental arm

support and attention (usual care) OTHER

support and attention (usual care)

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged over 18 years old;
• Who received in the last 7 days the diagnosis of metastatic incurable bladder, prostate, kidney, colorectal or sarcoma cancer (including recurrence) during the announcement visit;
• Whose life expectancy is estimated ≥ 6 months by their treating oncologist;
• Who have a WHO performance score \< 3 (to be coherent with the life expectancy);
• Who have an albumin level \> 30g/liter (patients with an acceptable state of nutrition);
• Who gave their signed consent to participate in the study;
• Who are covered by a social insurance.

You may not qualify if:

• Patients diagnosed with cerebral metastases;
• Patients with locally advanced cancer without metastases;
• Patients with an advanced or metastatic cancer amenable to curative intent treatment;
• Patients suffering from a psychological vulnerability that might alter their reasoning or judgment capacities;
• Patients with a psychological or physical incapacity to answer the questionnaires, attested by the medical staff;
• Patients under custodial sentence or under tutelage or protection of vulnerable adults

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• SCALab UMR CNRS 9193 Université de Lille: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Kidney Neoplasms; Stress Disorders, Post-Traumatic; Neoplasms

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Kidney Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Georges-Michel REICH, MD

  Centre oscar Lambret de Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The research assistant blind to group assignments is responsible to conduct the three follows-ups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: July 25, 2018
• Primary Completion: August 27, 2019
• Study Completion: June 10, 2020
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (1)