Effect of Hypnosis in the Management of Anxiety and Chemo-induced Symptoms in Adolescents and Young Adults With Sarcoma or Germ Cell Tumor and in Young Women With Breast Cancer

Официальное название

Effect of Hypnosis in the Management of Anxiety and Chemo-induced Symptoms in Adolescents and Young Adults With Sarcoma or Germ Cell Tumor and in Young Women With Breast Cancer.

Обзор

The HYPNO-AJA 2 study is a prospective single-center interventional clinical trial conducted at the Institut Bergonié to evaluate the effectiveness of hypnosis in reducing anxiety and chemotherapy-related symptoms in adolescents, young adults (AYAs), and young women undergoing cancer treatment. The study focuses on patients aged 15-39 with sarcoma or germ cell tumors and women aged 15-49 with breast cancer receiving neoadjuvant chemotherapy. Cancer treatment in AYAs is frequently associated with high levels of psychological distress, particularly anxiety related to chemotherapy sessions, invasive procedures, and repeated hospitalizations. Previous studies suggest that hypnosis may help reduce anxiety, pain, nausea, and emotional distress in oncology patients, but evidence remains limited in AYA populations and specific cancer types such as sarcoma, germ cell tumors, and breast cancer. HYPNO-AJA 2 aims to address this gap by assessing the feasibility, safety, and therapeutic value of hypnosis during chemotherapy. The study's primary objective is to determine whether hypnosis can significantly reduce anxiety symptoms during chemotherapy. Secondary objectives include evaluating its effects on nausea and vomiting, pain, medication consumption (anxiolytics and antiemetics), quality of life, body image perception, and patient satisfaction. The trial will include 70 participants divided into two cohorts: * 35 hospitalized patients with sarcoma or germ cell tumors; * 35 outpatients with breast cancer treated in a day hospital setting. Eligible participants must be newly diagnosed, treated at Institut Bergonié, and receiving chemotherapy based on anthracyclines and/or alkylating agents. Patients with contraindications to hypnosis, severe psychiatric or cognitive disorders, recent hypnosis exposure, or inability to comply with follow-up procedures are excluded. The intervention consists of a hypnosis session performed during the second chemotherapy cycle by a specialized oncology nurse trained in Ericksonian hypnosis and pain management. Sessions will last between 30 and 60 minutes and take place in a private and comfortable environment. The hypnosis procedure includes a preparatory discussion, hypnotic induction, progressive return to normal consciousness, and debriefing adapted to the patient's needs. Anxiety levels will be assessed using a Visual Analog Scale (VAS-Anxiety) before and after chemotherapy cycles 1, 2, and 3. Cycle 2 includes hypnosis, whereas cycles 1 and 3 do not. The primary endpoint is the difference in anxiety levels after cycle 2 compared with cycle 3. Secondary outcomes will evaluate chemotherapy-induced nausea and vomiting using the PRO-CTCAE system, pain intensity, medication use, quality of life through the EORTC QLQ-C30 questionnaire, body image changes using the Body Image Scale, and satisfaction with hypnosis sessions. The planned enrollment period is 18 months, with a total study duration of 24 months and individual patient participation lasting approximately six months. Statistical analyses will compare anxiety scores after chemotherapy with and without hypnosis using paired statistical tests. Based on preliminary results from the earlier HYPNO-AJA-1 pilot study, the sample size is expected to provide more than 90% statistical power to detect clinically meaningful reductions in anxiety. The investigators expect hypnosis to improve patients' psychological well-being, reduce symptom burden and medication use, enhance quality of life and body image acceptance, and strengthen the therapeutic relationship between patients and caregivers. More broadly, the study may support the integration of hypnosis into supportive oncology care pathways as a low-cost, non-pharmacological intervention adapted to young cancer patients.

Вмешательства

• Другое HYPNOSIS
  Hypnosis session will be performed at chemotherapy cycle 2

Первичные конечные точки

• Efficacy of hypnosis in terms of presence of reduction of anxiety disorders [Срок оценки: 3 months]

Вторичные конечные точки (3)

• Efficacy of hypnosis in terms of reduction of nausea [Срок оценки: 3 months]
• Efficacy of hypnosis in terms of reduction of vomiting [Срок оценки: 3 months]
• Efficacy of hypnosis in terms of reduction of pain [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Newly diagnosed patients receiving initial care and follow-up at the Institut Bergonié during treatment:

• Adolescents or young adults (AJA) aged 15 to 39 with soft tissue or bone sarcoma or a germ cell tumor (testicular, ovarian),
• Young women aged 15 to 49 with breast cancer.
• Treatment with neoadjuvant chemotherapy based on anthracyclines and/or alkylating agents.
• Treatment administered as:

• Inpatient for patients with soft tissue or bone sarcoma or a germ cell tumor (testicular, ovarian),
• Outpatient or day hospital for female patients with breast cancer.
• Dated and signed informed consent (if the patient is a minor, consent must also be signed by the legal guardians).
• Patient enrolled in a social security program in accordance with current regulations.

Критерии исключения

• Known contraindications to hypnosis (psychotic disorders, mental disorders, confusion, deafness, severe cognitive impairment, etc.)
• Patients who have already undergone hypnosis sessions within 6 months prior to enrollment.
• Geographic, social, or psychological factors rendering the patient unable to comply with the study's follow-up and procedures.
• Patients who are deprived of their liberty or subject to a legal protection measure (guardianship, conservatorship, judicial protection, or family authorization).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07614620 · IB 2026-01 · 2026-A00525-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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