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

February 8, 2024 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Hérault
      • Montpellier, Hérault, France, 34298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care
Other: Standard care
Standard care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Around 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days
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)
90 days
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.
90 days
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)
90 days
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.
90 days
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.
90 days
Number of days of hospitalization after surgery
Time Frame: 1 month
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.
90 days
Concentration of salivary immunoglobulin A
Time Frame: 90 days
90 days
Number of cardiac coherence sessions per day and by patient
Time Frame: Through the study, an average of 1 year
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
Through study completion, an average of 1 year
Number of patients satisfied with the cardiac coherence program
Time Frame: 90 days
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.
90 days
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
90 days
Composite anxiety symptomatology score
Time Frame: 90 days
Score including psychological, physiological and biological variables
90 days
Feedback from the instructor and investigator
Time Frame: 90 days
90 days
Recruitment and retention rates
Time Frame: 1 year
1 year
Duration of cardiac coherence sessions in minutes
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Estelle Guerdoux-Ninot, MD, Institut Regional du Cancer de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2019-12 COC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all disidentified participants' data, the study protocol, the statistical analysis plan and analytic code. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

IPD Sharing Time Frame

Access to study data upon written detailed request sent to ICM, following publication and until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limited to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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