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出境医 / 临床实验 / Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis (COCOON)

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

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 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
Layout table for study information
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 : May 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 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
Outcome Measures
Primary Outcome Measures :
  1. Cardiac Coherence Program Adherence Rate [ Time Frame: 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 :
  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
Layout table for eligibility information
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. 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)
Contacts and Locations

Contacts
Layout table for location contacts
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
Layout table for investigator information
Study Chair: Estelle Guerdoux-Ninot, MD Institut régional du cancer de Montpellier
Tracking Information
First Submitted Date  ICMJE July 15, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date May 13, 2021
Estimated Study Start Date  ICMJE May 2021
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2021) 		Cardiac Coherence Program Adherence Rate [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • 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.
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
  • 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.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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.
  • Number of days of hospitalization after surgery [ Time Frame: 1 month ]
  • 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.
  • Concentration of salivary immunoglobulin A [ Time Frame: 90 days ]
  • Number of cardiac coherence sessions per day and by patient [ Time Frame: Through the study, an average of 1 year ]
  • Reasons of non-participation reported by patients and registered in the form of inclusion [ Time Frame: Through study completion, an average of 1 year ]
  • Number of patients satisfied with the cardiac coherence program [ Time Frame: 90 days ]
  • 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.
  • 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
  • Composite anxiety symptomatology score [ Time Frame: 90 days ]
    Score including psychological, physiological and biological variables
  • Feedback from the instructor and investigator [ Time Frame: 90 days ]
  • Recruitment and retention rates [ Time Frame: 1 year ]
  • Duration of cardiac coherence sessions in minutes [ Time Frame: Through study completion, an average of 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • 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 pain and the position on the right an unbearable pain.
  • 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)
  • 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.
  • 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)
  • 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.
  • Quality of life by using the quality of life questionnaire core (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.
  • Number of days of hospitalization [ Time Frame: 1 month ]
  • Concentration of Cortisol [ Time Frame: 90 days ]
  • Concentration of immunoglobulin A [ Time Frame: 90 days ]
  • Frequency and practice of cardiac coherence [ Time Frame: 20 days ]
  • Preliminary costs of the cardiac coherence program [ Time Frame: 90 days ]
  • Proportion of patients who have participated in the cardiac coherence program [ Time Frame: 90 days ]
  • Number of patients not participating in the cardiac coherence program [ Time Frame: 90 days ]
  • Number of patients satisfied with the cardiac coherence program [ Time Frame: 90 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
Official Title  ICMJE Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Peritoneal Carcinomatosis
  • Pseudomyxoma Peritonei
  • Mesothelioma Peritoneum
Intervention  ICMJE
  • 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

  • Other: Standard care
    Standard care
Study Arms  ICMJE
  • Experimental: Coherence cardiac
    Intervention: Other: Cardiac coherence
  • Active Comparator: Standard care
    Intervention: Other: Standard care
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  • Satin JR, Linden W, Phillips MJ. Depression as a predictor of disease progression and mortality in cancer patients: a meta-analysis. Cancer. 2009 Nov 15;115(22):5349-61. doi: 10.1002/cncr.24561.
  • Cossu G, Saba L, Minerba L, Mascalchi M. Colorectal Cancer Screening: The Role of Psychological, Social and Background Factors in Decision-making Process. Clin Pract Epidemiol Ment Health. 2018 Mar 21;14:63-69. doi: 10.2174/1745017901814010063. eCollection 2018. Review.
  • Smith SK, Loscalzo M, Mayer C, Rosenstein DL. Best Practices in Oncology Distress Management: Beyond the Screen. Am Soc Clin Oncol Educ Book. 2018 May 23;38:813-821. doi: 10.1200/EDBK_201307. Review.
  • Wagner LI, Spiegel D, Pearman T. Using the science of psychosocial care to implement the new american college of surgeons commission on cancer distress screening standard. J Natl Compr Canc Netw. 2013 Feb 1;11(2):214-21. Review.
  • Dolbeault S, Boistard B, Meuric J, Copel L, Brédart A. Screening for distress and supportive care needs during the initial phase of the care process: a qualitative description of a clinical pilot experiment in a French cancer center. Psychooncology. 2011 Jun;20(6):585-93. doi: 10.1002/pon.1946. Epub 2011 Mar 22.
  • Dolbeault S, Bredart A, Mignot V, Hardy P, Gauvain-Piquard A, Mandereau L, Asselain B, Medioni J. Screening for psychological distress in two French cancer centers: feasibility and performance of the adapted distress thermometer. Palliat Support Care. 2008 Jun;6(2):107-17. doi: 10.1017/S1478951508000187.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2020) 		60
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2019) 		59
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Pierre BLEUSE, MD 4 67 61 31 02 ext +33 DRCI-icm105@icm.unicancer.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04024917
Other Study ID Numbers  ICMJE PROICM 2019-12 COC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Estelle Guerdoux-Ninot, MD Institut régional du cancer de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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