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

Sponsor
Institut Bergonié
Study ID
NCT07614620
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • HYPNOSIS — OTHER
    Hypnosis session will be performed at chemotherapy cycle 2

Study Details

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.

Key Dates

First listed
May 29, 2026
Start date
Sep 15, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: HYPNOSIS

Primary Outcome Measure

Efficacy of hypnosis in terms of presence of reduction of anxiety disorders [ Time Frame: 3 months ]

Central Contacts

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