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临床试验/NCT06021093
NCT06021093招募中不适用

HYPNotherapy for Improving Distress and Sleep in Adolescents and Young Adults With Cancer; a Feasibility Study (HYPNAYA Feasibility Study)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Feasibility of hypnotherapy as supportive treatment for AYA patients

研究概览

简要总结

Adolescents and young adults (AYAs) with a cancer diagnosis experience high levels of stress during and after treatment. Hypnotherapy as supportive treatment throughout regular cancer care may reduce symptoms of distress, and improve sleep and health-related quality of life in AYAs with cancer. The objective of this pilot study is to demonstrate feasibility of hypnotherapy as supportive treatment.

详细描述

Study design: The HYPNAYA feasibility study is an interventional prospective single center cohort study with pre- and post-measurements. Patients will be consecutively recruited at the medical oncology department of the Amsterdam UMC. Participants will receive two hypnotherapy sessions including homebased exercises. At baseline, 8 and 12 weeks after the first hypnotherapy session, patients will be asked to fill in questionnaires.

Study population: consecutive AYAs (age 18-39) at the (outpatient) clinic undergoing systemic treatment or follow-up up to 6 months after finishing medical treatment. Patients that are actively treated by a psychiatrist, mentally incompetent (based on the opinion of the treating physician) or previously received hypnotherapy will be excluded.

Studie intervention: the hypnotherapy will include 2 individual hypnotherapy sessions plus daily listening to these recorded sessions and to (3 or 4) standardized hypnosis recordings. The individual sessions will be provided by CF and ET, both certified hypnotherapists and health care professionals (respectively nurse and physician). Preferably, these sessions take place during a planned admission for chemotherapy. If preferred by the patient, this can also take place at the hypnotherapist's office. If preferred by the patient, this can also take place at the venue of the hypnotherapist. A large part of the first session will be devoted to answering participants' questions and giving information about hypnosis, followed by exercises as an introduction to hypnosis. The goal of these exercises is to enable participants to increase their awareness and abilities in accessing mental imagery and hypnosis. At the end of the session, information will be provided about the home-based practice. This will consist of daily listening to prerecorded standardized hypnosis exercises for three months. These are standardized hypnosis excercises that will be specifically developed for this study and will be provided to all participants in the study. It will be explained that daily listening is essential to take full advantage of hypnosis without the help of a therapist. The second individual session will be scheduled 4-6 weeks later. During the second meeting, a new hypnosis exercise will be introduced and questions about the hypnotic exercises will be answered. Suggestions given during the hypnosis exercises will be focused on relaxation, improvement of sleep, more energy, ego-strengthening and improvement of feelings of anxiety and depression. It will again be explained that daily listening is essential to take full advantage of hypnosis without the help of a therapist.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility of hypnotherapy as supportive treatment for AYA patients

时间窗: 8 weeks

The primary outcome is feasibility of hypnotherapy as supportive treatment for AYA patients defined as the proportion of patients that complete the 8 weeks of treatment. Complete is defined as attending both individual hypnotherapy sessions.

次要结局

  • Health-related quality of life(0, 8 and 12 weeks)
  • Feasibility of self-hypnosis(8 and 12 weeks)
  • Distress (i.e. depression)(0, 8 and 12 weeks)
  • Patient-reported satisfaction of medical hypnosis(8 and 12 weeks)
  • Reach of medical hypnosis(1 year)
  • Fear of cancer progression(0, 8 and 12 weeks)
  • Change in fear of cancer progression(0, 8 and 12 weeks)
  • Feasibility of included questionnaires(0, 8 and 12 weeks)
  • Distress (i.e. anxiety)(0, 8 and 12 weeks)
  • Quality of sleep(0, 8 and 12 weeks)
  • Change in distress (i.e. depression)(0, 8 and 12 weeks)
  • Change in health-related quality of life(0, 8 and 12 weeks)
  • Change in distress (i.e. anxiety)(0, 8 and 12 weeks)
  • Change in quality of sleep(0, 8 and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacqueline M. Tromp

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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