Prostate Cancer Clinical Trial
— NeuroPrevPTSDOfficial 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
Verified date | July 2020 |
Source | Centre Oscar Lambret |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | August 27, 2019 |
Est. primary completion date | August 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Oscar Lambret | Lille |
Lead Sponsor | Collaborator |
---|---|
Centre Oscar Lambret | SCALab UMR CNRS 9193 Université de Lille |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Evolution of PCL-5 score in the first 3 months in the patient | 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. |
3 months | |
Secondary | The quality of life (QoL) score of the patient: EQ-5D | 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 months | |
Secondary | Quality-adjusted life years (QALY) of the patient | 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. | 3 months | |
Secondary | Inflammation level in the patients | Inflammation level will be assessed using CRP and albumin level | 3 months | |
Secondary | Emotion regulation in the patients | 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. | 3 months | |
Secondary | Overall survival of the patients | Overall survival from randomization | 3 months | |
Secondary | PCL-5 score improvement in the partner | 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. | 3 months | |
Secondary | PCL-5 score evolution in the partner | 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. | 3 months | |
Secondary | Quality of life of the partner: EQ-5D scale | 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 months | |
Secondary | Emotion regulation | 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. | 3 months |
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