Prostate Cancer Clinical Trial
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
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.
Procedure for patients and partners:
Patients will be informed about the study by their treating oncologist at the end of the
appointment, when they will be informed about the metastatic incurable progression of their
disease (announcement visit). Oncologists will provide the patients a written description of
the study, presenting the information previously orally provided by them, together with the
consent form, to fill in. Signed informed consent will be sent back by post-mail if necessary
(if participants ask for a time to think), using a pre-stamped envelope. Due to the objective
to prevent distress, recruitment to the study and random assignment of the intervention need
to be performed within the 7 days following this announcement visit, after making sure the
patient is eligible for the study according to the inclusion and exclusion criteria.
Early after the announcement visit and consent collection, the clinical psychologist will
call the patient before randomization in order to assess patients' level of stress from 1 (no
stress) to 10 (maximal stress). Patients with a level higher or equal than 4 will be
randomized in the study. For the patients with a stress level below or equal than 3, only
background information will be collected in the study. These patients will receive the
standard care.
Patients and their spouse will be randomly assigned together (i.e., if the spouse
participates, he/she will be allocated to the same treatment arm as the patient) to receive
the MSI + VB (experimental group) or to receive the supportive listening and attention (usual
care serving as control condition), using an online centralized randomization program.
Randomization will be implemented after the receipt of the consent form and balanced by (1)
cancer type (bladder, prostate, kidney, colorectal cancer, sarcoma), (2) gender, as these two
variables are identified as risk factors of PTSD (for cancer type) and as impacting the MSI
effects (for gender) in the literature, and (3) the presence of the spouse during the
announcement visit (yes/no), using a dynamic allocation program (minimization with a random
factor set at 0.8).
For reasons of feasibility, no pre-screening aiming at including patients with a high risk of
distress and potentially with high risk for developing PTSD will be realized. However, during
the first telephone session, the psychologist will assess patients' level of stress using a
10-point likert scale, similar to a past study, before and after the MSI + VB intervention or
the support and attention control session. This scale includes asking patients on a scale
from 1 (no stress) to 10 (maximal stress) their level The treatment consists of a single
telephone session conducted by a trained therapist maximum 10 days after receiving the
announcement of the incurable disease progression. This is done in order to prevent PTSD, as
was already done when the MSI treatment was developed in traffic accident survivors (Gidron
et al., 2001, 2007). The same trained therapist will provide the MSI + VB intervention to the
experimental group and give support and attention to the control group, in order to control
for therapist's effects. This telephone session will be followed by 3 follow-up telephone
assessments (a week, a month and 3 months after the previous telephone session), for
collecting data by a research assistant who will not know in which group the participants
are. All the sessions and interviews of the patient and his/her spouse (for treatments and
for follow-up measures) will be conducted separately, and the information will remain
confidential between the patient and the spouse. Each of these telephone calls will be
conducted from the participating center, in order contact details of the participants remain
inside the medical center to ensure the confidentiality of the data.
Experimental intervention. 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). 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.
patients in the MSI + VB group will be encouraged to perform it daily, for 5-10min, and
especially before going to bed, to reduce any sleeping arousal associated with PTSD symptoms
Control. 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.
At Baseline for both arms, i.e., at the beginning of the telephone interview where the
trained therapist will call the participants, the therapist will collect background
information including age, gender, years of education, self-reported length of couple
relationship and psychotropic medication (anxiolytic, antidepressant) in order to control the
association between PTSD symptoms and anxiety and/or depressive disorder.
1. PTSD symptoms will be assessed by the post-traumatic checklist for DSM 5 (PCL-5;
Weathers et al., 2013, French translation and validation by Ashbaugh et al., 2016).
2. Emotional regulation will be assessed by the BACQ scale (Finset et al., 2002).
3. Quality of life will be assessed by the EuroQol-5D scale (EQ-5D 3L)
In both groups, the trained therapist will also evaluate the degree of "natural" structuring
regarding the way in which the patients/partners talk about the announcement visit. More
precisely, the trained therapist will rate both groups on their level of chronological
organization of their story from 1 = totally disorganized; 2 = a bit organized; 3 =
chronologically very organized (in the MSI + VB group: before and after the MSI training; in
the control group: at the first time they recall their story)
Afterwards, three follows-ups will be conducted by telephone: 1 week, 1 month and 3 months
after the first intervention or control phone session.A research assistant blind to group
assignments will collect the same self-reported measures initially collected by telephone at
the first phone meeting. In sum, levels of PTSD symptoms and quality of life will be assessed
at each time (initial phone meeting, 1 week, 1 month and 3 months). However, emotional
regulation will be assessed at the first phone meeting and at one month only, in order to
reduce patients' burden.
Patients and partners will also be asked if they have talked about the event, to recall how
and how often they have spoken about the event since the last phone call.
For all the groups, medical information including type and stage of cancer and type of cancer
treatments will be collected at baseline by the medical staff (as summarized in the table
below). Levels of albumin and levels of C-reactive protein (CRP, reflecting inflammation)
will also be obtained at baseline, 1 month and 3 months when patients will come in any case
to the hospital for their medical appointments (no medical appointment is anticipated at 1
week, hence the absence of CRP and albumin measures at this time). Survival time will be
monitored for all patients as well until the final analysis. We will calculate the
quality-adjusted life years (QALY) for all patients, to reflect both quantity and quality of
survival. This will be done using the length of survival weighted by patients' score on the
EQ-5D scale.
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