Peritoneal Carcinomatosis Clinical Trial
— COCOONOfficial title:
Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study
The investigator proposes to use the cardiac coherence technique to diminish anxiety before the surgery of a peritoneal carcinosis of colon or stomach or ovary and pseudomyxoma or peritoneal mesothelioma.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age over 18 years 2. Patients with peritoneal carcinosis awaiting cytoreductive surgery 3. Patients who scored strictly above 3 on the visual analogue anxiety scale and/or the psychological distress scale 4. Patients with sufficient command of the French language 5. Patient affiliated to a French social security system 6. Patient hospitalized at the Institute of cancer of Montpellier the day before his cytoreductive surgery (at T1 = D-1) 7. Signing of informed consent before any specific trial procedure Exclusion Criteria: 1. Patients who already have daily practice of cardiac coherence 2. Presence of proven psychiatric disorders (e.g., mental retardation, psychotic disorders, learning disabilities, attention deficit/hyperactivity, bipolar disorder, etc.) other than mood disorders that are reactive to the disease experience, or receiving psychotic treatment that may impair thinking, judgment or discernment 3. Physical or sensory inability to respond to questionnaires 4. Patients who have had a heart transplant or bypass surgery in the Year before surgery 5. Patient with a history of uncontrolled neurological pathology within the last 6 months before inclusion in the trial 6. Patients with a history of psychoactive substance dependence (excluding smoking) in the last 6 months before inclusion in the trial 7. Patients with brain metastases 8. Known natural bradycardia 50 beats per minute 9. Beta-blocker intake in progress (digoxin, flecaine, isoptin, cordarone, diltiazem) 10. Ongoing cardiac arrhythmias 11. Known severe heart failure with ventricular ejection fraction strictly Below 40 % 12. Chronic uncontrolled pain and making it difficult to practice the technique 13. Patient with chronic obstructive pulmonary disease 14. Legal incapacity (patient under guardianship or curatorship) |
Country | Name | City | State |
---|---|---|---|
France | ICM | Montpellier | Hérault |
Lead Sponsor | Collaborator |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle |
France,
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac Coherence Program Adherence Rate | Cardiac Coherence Program Adherence Rate. Patients are considered in "success" adhere to the program) if they will perform at least 20 of the 30 sessions scheduled until surgery (minimum 1 practice per day). | Around 10 days | |
Secondary | Anxiety by using the visual analogue scale (VAS) | This scale measures the anxiety of patient. It's a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a (usually) 10 cm line. The points at which respondents make their mark represent where they perceive their answer to lie in this continuum. The distance between their mark and one end (or the mid-point) of the scale is recorded. The position on the left being the absence of anxiety and the position on the right an unbearable anxiety. | 90 days | |
Secondary | Anxiety and depression by using the hospital anxiety and depression scale (HADS) | One subscale for evaluation of anxiety from 0 (lower anxiety) to 21 (higher anxiety) and the other subscale for depression from 0 (lower anxiety) to 21 (higher depression) | 90 days | |
Secondary | Psychological distress scale | This scale measures the psychological distress of the patient . Psychological distress is characterized by the presence of symptoms, most often depressive or anxious.It's a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a line. The position of the mark on the top is the higher psychological distress and at the bottom the lower psychological distress. | 90 days | |
Secondary | Generalized anxiety by using Freeston's uncertainty tolerance scale | The scale is used to identify people with generalized anxiety disorder compared to people with other anxiety disorders or people without pathologies. Range is from 27 (lower uncertainty) to 135 (higher uncertainty) | 90 days | |
Secondary | Heart rate variability | The heart rate variability is determined by using the software EmWave Pro which measures the ratio low frequencies/high frequencies. | 90 days | |
Secondary | Quality of life by using the quality of life questionnaire score (QLQ-C30) | The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome. |
90 days | |
Secondary | Number of days of hospitalization after surgery | 1 month | ||
Secondary | Pain by using the visual analogue scale (VAS) | This scale measures the pain of patient. It's a visual analogue scale which is also known as linear analogue scale. These scales require respondents to place a mark on a line on which opposing statements or descriptions are placed at either end of a (usually) 10 cm line. The points at which respondents make their mark represent where they perceive their answer to lie in this continuum. The distance between their mark and one end (or the mid-point) of the scale is recorded. The position on the left being the absence of pain and the position on the right an unbearable pain. | 90 days | |
Secondary | Concentration of salivary immunoglobulin A | 90 days | ||
Secondary | Number of cardiac coherence sessions per day and by patient | Through the study, an average of 1 year | ||
Secondary | Reasons of non-participation reported by patients and registered in the form of inclusion | Through study completion, an average of 1 year | ||
Secondary | Number of patients satisfied with the cardiac coherence program | 90 days | ||
Secondary | Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire | State anxiety reflects the current emotional state, which allows the patient's nervousness and worry to be assessed during the session. The range is from 20 (lower anxiety) to 80 (higher anxiety). The patient must answer 20 questions for each part, each answer being on a 4 point Likert scale. | 90 days | |
Secondary | Subjective anxiety score by using the state-trait anxiety inventory form B (STAI-Y form B) questionnaire | Trait anxiety reflects the usual emotional state. The range is from 20 (lower anxiety) to 80 (higher anxiety).The patient must answer 20 questions for each part, each answer being on a 4 point Likert scale | 90 days | |
Secondary | Composite anxiety symptomatology score | Score including psychological, physiological and biological variables | 90 days | |
Secondary | Feedback from the instructor and investigator | 90 days | ||
Secondary | Recruitment and retention rates | 1 year | ||
Secondary | Duration of cardiac coherence sessions in minutes | Through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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