Implementation of a Cardiac Coherence Program to Reduce Anxiety in Patients With Peritoneal Carcinosis Treated by Surgery: Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cardiac Coherence Program Adherence Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Coherence cardiac
干预措施: Cardiac coherence (Other)
Standard care
干预措施: Standard care (Other)
结局指标
主要结局
Cardiac Coherence Program Adherence Rate
时间窗: 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).
次要结局
- Anxiety and depression by using the hospital anxiety and depression scale (HADS)(90 days)
- Generalized anxiety by using Freeston's uncertainty tolerance scale(90 days)
- Concentration of salivary immunoglobulin A(90 days)
- Number of cardiac coherence sessions per day and by patient(Through the study, an average of 1 year)
- Feedback from the instructor and investigator(90 days)
- Heart rate variability(90 days)
- Psychological distress scale(90 days)
- Subjective anxiety score by using the state-trait anxiety inventory form A (STAI-Y form A) questionnaire(90 days)
- Recruitment and retention rates(1 year)
- Reasons of non-participation reported by patients and registered in the form of inclusion(Through study completion, an average of 1 year)
- Subjective anxiety score by using the state-trait anxiety inventory form B (STAI-Y form B) questionnaire(90 days)
- Anxiety by using the visual analogue scale (VAS)(90 days)
- Quality of life by using the quality of life questionnaire score (QLQ-C30)(90 days)
- Number of days of hospitalization after surgery(1 month)
- Pain by using the visual analogue scale (VAS)(90 days)
- Number of patients satisfied with the cardiac coherence program(90 days)
- Composite anxiety symptomatology score(90 days)
- Duration of cardiac coherence sessions in minutes(Through study completion, an average of 1 year)