COCOON: Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle (Other)

Overall Status

Recruiting

CT.gov ID

NCT04024917

Collaborator

(none)

Enrollment

Location

Arms

14.3

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Carcinomatosis Pseudomyxoma Peritonei Mesothelioma Peritoneum	Other: Cardiac coherence Other: Standard care	N/A

Detailed Description

Facing a Peritoneal Carcinomatosis (PC) diagnosis requires significant psychological adjustments that may generate major distress because of heavy care and a sometimes poor prognosis. Psychological distress, which most frequently results in emotional anxiety and depressive disorders, affects nearly 40% of patients in oncology. These disorders impair their quality of life, their health behaviours, their therapeutic alliance with caregivers, and represent a risk factor for mortality since access to care, lifestyle and therapeutic adherence differ. All learned societies (e.g., American Society of Clinical Oncology - ASCO), associations (e.g., Union for International Cancer Control (UICC), World Cancer Research Fund International - WCRF) and authorities (e.g., French National Institute of Cancer) recommend both the screening and treatment of this psychological distress. This complementary therapy should be integrated in the overall management of cancer patients, especially since anxiolytics (e.g., benzodiazepines) have shown limitations in clinical trials compared with placebo or standard care. Studies evaluating relevant psychological interventions to treat these disorders are rare. It is therefore essential to assess the feasibility and relevance of implementing a non-drug intervention known for its anxiolytic and antidepressant effects, to respond early and appropriately to the distress and anxiety of patients with PC before and after their surgery. Among the various existing non-drug interventions, a targeted cardiac coherence program seems promising. Cardiac coherence corresponds to a physiological state of balance of the autonomic nervous system obtained through precise and rigorous breathing exercises. Several pilot studies justify its interest in oncology. The main objective of this study is to evaluate adherence to a cardiac coherence program aimed at reducing anxiety in patients with PC awaiting cytoreductive surgery. The secondary objectives are to evaluate the implementation of this program in a cancer center, its adoption by the patients and the impact of this practice on their anxious symptomatology, immunological response and quality of life.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study

Actual Study Start Date :

Sep 21, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coherence cardiac	Other: Cardiac coherence An initiation session to cardiac coherence will take place D-11 before the operation (during the surgical consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape. 3 cardiac coherence sessions per day of 5 min (before meals) during the 11 days preceding the operation. - The program cardiac coherence will be performed during 90 days after the surgery
Active Comparator: Standard care	Other: Standard care Standard care

Arm

Intervention/Treatment

Experimental: Coherence cardiac

Other: Cardiac coherence

An initiation session to cardiac coherence will take place D-11 before the operation (during the surgical consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape. 3 cardiac coherence sessions per day of 5 min (before meals) during the 11 days preceding the operation. - The program cardiac coherence will be performed during 90 days after the surgery

Active Comparator: Standard care

Other: Standard care

Standard care

Outcome Measures

Primary Outcome Measures

Cardiac Coherence Program Adherence Rate [Around 10 days]
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).

Secondary Outcome Measures

Anxiety by using the visual analogue scale (VAS) [90 days]
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.
Anxiety and depression by using the hospital anxiety and depression scale (HADS) [90 days]
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)
Psychological distress scale [90 days]
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.
Generalized anxiety by using Freeston's uncertainty tolerance scale [90 days]
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)
Heart rate variability [90 days]
The heart rate variability is determined by using the software EmWave Pro which measures the ratio low frequencies/high frequencies.
Quality of life by using the quality of life questionnaire score (QLQ-C30) [90 days]
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.
Number of days of hospitalization after surgery [1 month]
Pain by using the visual analogue scale (VAS) [90 days]
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.
Concentration of salivary immunoglobulin A [90 days]
Number of cardiac coherence sessions per day and by patient [Through the study, an average of 1 year]
Reasons of non-participation reported by patients and registered in the form of inclusion [Through study completion, an average of 1 year]
Number of patients satisfied with the cardiac coherence program [90 days]
Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire [90 days]
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.
Subjective anxiety score by using the state-trait anxiety inventory form B (STAI-Y form B) questionnaire [90 days]
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
Composite anxiety symptomatology score [90 days]
Score including psychological, physiological and biological variables
Feedback from the instructor and investigator [90 days]
Recruitment and retention rates [1 year]
Duration of cardiac coherence sessions in minutes [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age over 18 years
Patients with peritoneal carcinosis awaiting cytoreductive surgery
Patients who scored strictly above 3 on the visual analogue anxiety scale and/or the psychological distress scale
Patients with sufficient command of the French language
Patient affiliated to a French social security system
Patient hospitalized at the Institute of cancer of Montpellier the day before his cytoreductive surgery (at T1 = D-1)
Signing of informed consent before any specific trial procedure

Exclusion Criteria:

Patients who already have daily practice of cardiac coherence
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
Physical or sensory inability to respond to questionnaires
Patients who have had a heart transplant or bypass surgery in the Year before surgery
Patient with a history of uncontrolled neurological pathology within the last 6 months before inclusion in the trial
Patients with a history of psychoactive substance dependence (excluding smoking) in the last 6 months before inclusion in the trial
Patients with brain metastases
Known natural bradycardia 50 beats per minute
Beta-blocker intake in progress (digoxin, flecaine, isoptin, cordarone, diltiazem)
Ongoing cardiac arrhythmias
Known severe heart failure with ventricular ejection fraction strictly Below 40 %
Chronic uncontrolled pain and making it difficult to practice the technique
Patient with chronic obstructive pulmonary disease
Legal incapacity (patient under guardianship or curatorship)