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Effects of a Neuroscience-based Technique on Post-traumatic Stress Disorder Symptoms, Inflammation, and Survival in Cancer Patients Announced of a Palliative Disease Progression and Their Partners (NeuroPrevPTSD)

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ClinicalTrials.gov Identifier: NCT03652298
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
SCALab UMR CNRS 9193 Université de Lille
Information provided by (Responsible Party):
Centre Oscar Lambret

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Bladder Cancer Prostate Cancer Kidney Cancer Advanced Sarcoma Other: Memory structuring intervention + Vagal breathing Other: support and attention (usual care) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomized
Masking: Single (Investigator)
Masking Description: The research assistant blind to group assignments is responsible to conduct the three follows-ups
Primary Purpose: Prevention
Official Title: Effects of a Neuroscience-based Technique on Post-traumatic Stress Disorder Symptoms, Inflammation, and Survival in Cancer Patients Announced of a Palliative Disease Progression and Their Partners
Actual Study Start Date : July 25, 2018
Estimated Primary Completion Date : May 25, 2020
Estimated Study Completion Date : July 25, 2021


Arm Intervention/treatment
Experimental: Experimental arm
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

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


Control Arm
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)
support and attention (usual care)




Primary Outcome Measures :
  1. PCL-5 score measurement at at 3 months (+/- 2 weeks) by the patient [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Evolution of PCL-5 score in the first 3 months in the patient [ Time Frame: 3 months ]

    Comparison of the PCL-5 score (PTSD symptoms severity score obtained by summing the scores for each of the 20 items) at 1 week, 1 month and 3 months after the first intervention.

    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.


  2. The quality of life (QoL) score of the patient: EQ-5D [ Time Frame: 3 months ]
    EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state in each of the dimensions. This decision results into a 1-digit number (number 1, 2, or 3) that expresses having no problems for 1, having some problems for 2, and having extreme problems for 3. The digits for the five dimensions is combined into a 5-digit number that describes the patient's health state, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

  3. Quality-adjusted life years (QALY) of the patient [ Time Frame: 3 months ]
    QALY is the Quality-adjusted life years. This outcome will be calculating using the EQ-5D score and the survival time ,in order to take into account both the quantity and quality of life generated by an intervention. One QALY equates to one year in perfect health. If an individual's health is below this maximum, QALYs are accrued at a rate of less than 1 per year. To be dead is associated with 0 QALYs.

  4. Inflammation level in the patients [ Time Frame: 3 months ]
    Inflammation level will be assessed using CRP and albumin level

  5. Emotion regulation in the patients [ Time Frame: 3 months ]
    Emotion regulation evaluated by the BACQ scale. BACQ scale is the Brief Approach/Avoidance Coping Questionnaire.The scale contains 12 items based on a 5-point Likert scale ranging from 1 " Strongly disagree " to 5 "Totally agree ". The total score is calculated by the sum of the items (ranging from 12 to 60). It is also possible to calculate three subscores (i.e., approach index; resignation and withdrawal index; diversion index). The higher the total score, the more the participant use an approach coping.

  6. Overall survival of the patients [ Time Frame: 3 months ]
    Overall survival from randomization

  7. PCL-5 score improvement in the partner [ Time Frame: 3 months ]
    Improvement of the PCL-5 score at 3 months compared to Baseline. 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.

  8. PCL-5 score evolution in the partner [ Time Frame: 3 months ]
    Evolution of PCL-5 score in the first 3 months, especially at 1 month. 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.

  9. Quality of life of the partner: EQ-5D scale [ Time Frame: 3 months ]
    EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his health state in each of the dimensions. This decision results into a 1-digit number (number 1, 2, or 3) that expresses having no problems for 1, having some problems for 2, and having extreme problems for 3. The digits for the five dimensions is combined into a 5-digit number that describes the patient's health state, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.

  10. Emotion regulation [ Time Frame: 3 months ]
    Emotion regulation evaluated by the BACQ scale. BACQ scale is the Brief Approach/Avoidance Coping Questionnaire.The scale contains 12 items based on a 5-point Likert scale ranging from 1 " Strongly disagree " to 5 "Totally agree ". The total score is calculated by the sum of the items (ranging from 12 to 60). It is also possible to calculate three subscores (i.e., approach index; resignation and withdrawal index; diversion index). The higher the total score, the more the participant use an approach coping.



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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 Criteria:

  • 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.

Exclusion Criteria:

  • 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

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): NCT03652298


Contacts
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Contact: Yori GIDRON, PhD 03 20 41 72 05 yori.gidron2@univ-lille3.fr
Contact: Georges-Michel REICH, MD 03 20 29 55 86 M-Reich@o-lambret.fr

Locations
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France
Centre Oscar Lambret Recruiting
Lille, France
Contact: Georges-Michel REICH, MD    03 20 29 55 86    M-Reich@o-lambret.fr   
Sponsors and Collaborators
Centre Oscar Lambret
SCALab UMR CNRS 9193 Université de Lille
Investigators
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Principal Investigator: Georges-Michel REICH, MD Centre oscar Lambret de Lille

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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT03652298    
Other Study ID Numbers: NeuroPrevPTSD-1804
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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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 Centre Oscar Lambret:
PTSD
Memory Structuring Intervention (MSI)
Cancer
Vagal breathing
Additional relevant MeSH terms:
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Kidney Neoplasms
Inflammation
Disease Progression
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Pathologic Processes
Urologic Neoplasms
Urologic Diseases
Disease Attributes
Trauma and Stressor Related Disorders
Mental Disorders
Kidney Diseases