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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Cardiac Coherence Program Adherence Rate [Time frame: Around 10 days]

Secondary outcome measures (12)

• Anxiety by using the visual analogue scale (VAS) [Time frame: 90 days]
• Anxiety and depression by using the hospital anxiety and depression scale (HADS) [Time frame: 90 days]
• Psychological distress scale [Time frame: 90 days]
• Generalized anxiety by using Freeston's uncertainty tolerance scale [Time frame: 90 days]
• Heart rate variability [Time frame: 90 days]
• Quality of life by using the quality of life questionnaire score (QLQ-C30) [Time frame: 90 days]
• Number of days of hospitalization after surgery [Time frame: 1 month]
• Pain by using the visual analogue scale (VAS) [Time frame: 90 days]
• 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]

Eligibility criteria

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
• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• ICM — Montpellier

Publications

• Dodson RM, McQuellon RP, Mogal HD, Duckworth KE, Russell GB, Votanopoulos KI, Shen P, Levine EA. Quality-of-Life Evaluation After Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy. Ann Surg Oncol. 2016 Dec;23(Suppl 5):772-783. doi: 10.1245/s10434-016-5547-y. Epub 2016 Sep 8. PMID 27638671
• Lloyd-Williams M, Dennis M, Taylor F. A prospective study to determine the association between physical symptoms and depression in patients with advanced cancer. Palliat Med. 2004 Sep;18(6):558-63. doi: 10.1191/0269216304pm923oa. PMID 15453627
• Pinquart M, Duberstein PR. Depression and cancer mortality: a meta-analysis. Psychol Med. 2010 Nov;40(11):1797-810. doi: 10.1017/S0033291709992285. Epub 2010 Jan 20. PMID 20085667
• Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44. doi: 10.1177/1054773803262222. PMID 15245638
• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
• Sugarbaker PH. Peritonectomy procedures. Ann Surg. 1995 Jan;221(1):29-42. doi: 10.1097/00000658-199501000-00004. PMID 7826158
• Tan G, Dao TK, Farmer L, Sutherland RJ, Gevirtz R. Heart rate variability (HRV) and posttraumatic stress disorder (PTSD): a pilot study. Appl Psychophysiol Biofeedback. 2011 Mar;36(1):27-35. doi: 10.1007/s10484-010-9141-y. PMID 20680439
• Bartos A, Bartos D, Raluca S, Mitre C, Hadade A, Iancu I, Cioltean C, Iancu C, Militaru C, Parau A, Breazu C. Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Peritoneal Carcinomatosis: Our Initial Experience. Chirurgia (Bucur). 2019 Mar-Apr;114(2):222-233. doi: 10.21614/chirurgia.114.2.222. PMID 31060655

Identifiers

NCT: NCT04024917 · PROICM 2019-12 COC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗