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

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ClinicalTrials.gov Identifier: NCT04024917
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Cardiac Coherence Program Adherence Rate [ Time Frame: Around 10 days ]
    At least 70% of patients enrolled in the program will perform at least 20 of the 30 sessions scheduled until surgery (minimum 1 session per day)


Secondary Outcome Measures :
  1. Anxiety by using the visual analogue scale (VAS) [ Time Frame: 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.

  2. Anxiety and depression by using the hospital anxiety and depression scale (HADS) [ Time Frame: 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)

  3. Psychological distress scale [ Time Frame: 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.

  4. Generalized anxiety by using Freeston's uncertainty tolerance scale [ Time Frame: 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)

  5. Heart rate variability [ Time Frame: 90 days ]
    The heart rate variability is determined by using the software EmWave Pro which measures the ratio low frequencies/high frequencies.

  6. Quality of life by using the quality of life questionnaire score (QLQ-C30) [ Time Frame: 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.


  7. Number of days of hospitalization after surgery [ Time Frame: 1 month ]
  8. Pain by using the visual analogue scale (VAS) [ Time Frame: 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.

  9. Concentration of salivary immunoglobulin A [ Time Frame: 90 days ]
  10. Number of cardiac coherence sessions per day and by patient [ Time Frame: Through the study, an average of 1 year ]
  11. Reasons of non-participation reported by patients and registered in the form of inclusion [ Time Frame: Through study completion, an average of 1 year ]
  12. Number of patients satisfied with the cardiac coherence program [ Time Frame: 90 days ]
  13. Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire [ Time Frame: 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.

  14. Subjective anxiety score by using the state-trait anxiety inventory form B (STAI-Y form B) questionnaire [ Time Frame: 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

  15. Composite anxiety symptomatology score [ Time Frame: 90 days ]
    Score including psychological, physiological and biological variables

  16. Feedback from the instructor and investigator [ Time Frame: 90 days ]
  17. Recruitment and retention rates [ Time Frame: 1 year ]
  18. Duration of cardiac coherence sessions in minutes [ Time Frame: Through study completion, an average of 1 year ]

Eligibility Criteria
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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:

  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. Natural bradycardia 50 beats per minute
  9. Beta-blocker intake in progress (digoxin, flecaine, isoptin, cordarone, diltiazem)
  10. Ongoing cardiac arrhythmias
  11. 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)
Contacts and Locations
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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): NCT04024917


Contacts
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Contact: Jean-Pierre BLEUSE, MD 4 67 61 31 02 ext +33 DRCI-icm105@icm.unicancer.fr

Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Study Chair: Estelle Guerdoux-Ninot, MD Institut régional du cancer de Montpellier
More Information
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Publications:

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT04024917    
Other Study ID Numbers: PROICM 2019-12 COC
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Institut du Cancer de Montpellier - Val d'Aurelle:
Colon
Rectum
Stomach
Ovary
Additional relevant MeSH terms:
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Mesothelioma
Carcinoma
Peritoneal Neoplasms
Pseudomyxoma Peritonei
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Mesothelial
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms, Cystic, Mucinous, and Serous