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

NCT04024917 | Recruiting

• 1 other identifier: PROICM 2019-12 COC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Carcinomatosis; Pseudomyxoma Peritonei; Mesothelioma Peritoneum

Keywords

Colon; Rectum; Stomach; Ovary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Anxiety by using the visual analogue scale (VAS)

  90 days

• Anxiety and depression by using the hospital anxiety and depression scale (HADS)

  90 days

• Psychological distress scale

  90 days

• Generalized anxiety by using Freeston's uncertainty tolerance scale

  90 days

• Heart rate variability

  90 days

Study Arms (2)

Coherence cardiac

EXPERIMENTAL

Other: Cardiac coherence

Standard care

ACTIVE COMPARATOR

Other: Standard care

Interventions

Cardiac coherence OTHER

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

Coherence cardiac

Standard care OTHER

Standard care

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with brain metastases
• Known natural bradycardia 50 beats per minute
• Beta-blocker intake in progress
• 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)

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

ICM

Montpellier, Hérault, 34298, France

RECRUITING

Related Publications (42)

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MeSH Terms

Conditions

Peritoneal Neoplasms; Pseudomyxoma Peritonei

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Adenocarcinoma, Mucinous; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Estelle Guerdoux-Ninot, MD

  Institut régional du cancer de Montpellier

  STUDY CHAIR

Central Study Contacts

Jean-Pierre BLEUSE, MD

CONTACT

4 67 61 31 02; DRCI-icm105@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 18, 2019
• Study Start: September 21, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Access to study data upon written detailed request sent to ICM, following publication and until 5 years after publication of summary data.
• 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.

Locations

FR (1)