Peritoneal CarcinomatosisCOCOONNCT04024917
Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis
A study testing Cardiac coherence in people with Peritoneal Carcinomatosis and Pseudomyxoma Peritonei, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis, Pseudomyxoma Peritonei, Mesothelioma Peritoneum
- What is being tested?
- Cardiac coherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2021to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ICM
Montpellier, Hérault, 34298
Jean-Pierre Bleuse, MD, 467613102 ext. +33, jean-pierre.bleuse@icm.unicancer.fr
Estelle Guerdoux, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Cardiac coherence, Standard care
- Keywords
- Colon, Rectum, Stomach, Ovary
- Medical subject headings
- Peritoneal Neoplasms, Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac coherenceOther
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
Standard careOther
Standard care
| Study group | Role | What they receive |
|---|---|---|
| Coherence cardiac | Experimental | Not described Receives: Other: Cardiac coherence |
| Standard care | Active comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Around 10 days
Secondary outcomes (18)
Anxiety by using the visual analogue scale (VAS)
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.
Measured: 90 days
Anxiety and depression by using the hospital anxiety and depression scale (HADS)
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)
Measured: 90 days
Psychological distress scale
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.
Measured: 90 days
Generalized anxiety by using Freeston's uncertainty tolerance scale
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)
Measured: 90 days
Heart rate variability
The heart rate variability is determined by using the software EmWave Pro which measures the ratio low frequencies/high frequencies.
Measured: 90 days
Quality of life by using the quality of life questionnaire score (QLQ-C30)
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.
Measured: 90 days
Number of days of hospitalization after surgery
Measured: 1 month
Pain by using the visual analogue scale (VAS)
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.
Measured: 90 days
Concentration of salivary immunoglobulin A
Measured: 90 days
Number of cardiac coherence sessions per day and by patient
Measured: Through the study, an average of 1 year
Reasons of non-participation reported by patients and registered in the form of inclusion
Measured: Through study completion, an average of 1 year
Number of patients satisfied with the cardiac coherence program
Measured: 90 days
Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire
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.
Measured: 90 days
Subjective anxiety score by using the state-trait anxiety inventory form B (STAI-Y form B) questionnaire
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
Measured: 90 days
Composite anxiety symptomatology score
Score including psychological, physiological and biological variables
Measured: 90 days
Feedback from the instructor and investigator
Measured: 90 days
Recruitment and retention rates
Measured: 1 year
Duration of cardiac coherence sessions in minutes
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start21 Sep 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estelle Guerdoux-Ninot, MD, Study chair, Institut régional du cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024917
- Sponsor's protocol ID
- PROICM 2019-12 COC
- Acronym
- COCOON
- Status last verified
- Jan 2026
- First submitted
- 15 Jul 2019
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 27638671Lloyd-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.
PubMed 15453627Pinquart 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.
PubMed 20085667Elkins 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.
PubMed 15245638Aaronson 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.
PubMed 8433390Sugarbaker PH. Peritonectomy procedures. Ann Surg. 1995 Jan;221(1):29-42. doi: 10.1097/00000658-199501000-00004.
PubMed 7826158Tan 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.
PubMed 20680439Bartos 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.
PubMed 31060655Glehen O, Mohamed F, Sugarbaker PH. Incomplete cytoreduction in 174 patients with peritoneal carcinomatosis from appendiceal malignancy. Ann Surg. 2004 Aug;240(2):278-85. doi: 10.1097/01.sla.0000133183.15705.71.
PubMed 15273552Piso P, Stierstorfer K, Gerken M, Klinkhammer-Schalke M. Benefit of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy in patients with isolated peritoneal metastases from colorectal cancer. Int J Colorectal Dis. 2018 Nov;33(11):1559-1567. doi: 10.1007/s00384-018-3146-z. Epub 2018 Aug 21.
PubMed 30132068Balaphas A, Belfontali V, Ris F, Lanitis A, Meier RP, Amram ML, Roth A, Huber O, Berney T, Morel P. [Management of peritoneal carcinomatosis with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy]. Rev Med Suisse. 2016 Jun 15;12(523):1190-4. French.
PubMed 27487625Minnella EM, Carli F. Prehabilitation and functional recovery for colorectal cancer patients. Eur J Surg Oncol. 2018 Jul;44(7):919-926. doi: 10.1016/j.ejso.2018.04.016. Epub 2018 Apr 30.
PubMed 29754828Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.
PubMed 21251875Carlson LE, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae JH, Martin M, Pelletier G, Robinson J, Simpson JS, Speca M, Tillotson L, Bultz BD. High levels of untreated distress and fatigue in cancer patients. Br J Cancer. 2004 Jun 14;90(12):2297-304. doi: 10.1038/sj.bjc.6601887.
PubMed 15162149Mehnert A, Hartung TJ, Friedrich M, Vehling S, Brahler E, Harter M, Keller M, Schulz H, Wegscheider K, Weis J, Koch U, Faller H. One in two cancer patients is significantly distressed: Prevalence and indicators of distress. Psychooncology. 2018 Jan;27(1):75-82. doi: 10.1002/pon.4464. Epub 2017 Jun 16.
PubMed 28568377