Clinical trial NCT06021093: HYPNAYA Feasibility Study
Official title: HYPNotherapy for Improving Distress and Sleep in Adolescents and Young Adults With Cancer; a Feasibility Study (HYPNAYA Feasibility Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AYA Cancer Patients
Keywords: Medical Hypnosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria

* Consecutive AYA patients undergoing systemic treatment or follow-up up to 6 months after finishing medical treatment at the Amsterdam University Medical Centers in Amsterdam, will be invited to participate.
* The Dutch definition of AYA is patients aged 18-39 years at cancer diagnosis.
* All patients need to be fluent in Dutch
* Able to understand the informed consent form
* Willing to provide written informed consent.

Exclusion criteria

* Patients that are actively treated by a psychiatrist will not be able to participate in this study to prevent interference with ongoing psychiatric treatment.
* Patients that are mentally incompetent (based on the opinion of the treating physician) will be excluded.
* Patients that previously received hypnotherapy will also be excluded.

Primary outcomes:
measure: Feasibility of hypnotherapy as supportive treatment for AYA patients
timeFrame: 8 weeks
Secondary outcomes:
measure: Feasibility of included questionnaires
timeFrame: 0, 8 and 12 weeks
measure: Feasibility of self-hypnosis
timeFrame: 8 and 12 weeks
measure: Patient-reported satisfaction of medical hypnosis
timeFrame: 8 and 12 weeks
measure: Reach of medical hypnosis
timeFrame: 1 year
measure: Distress (i.e. anxiety)
timeFrame: 0, 8 and 12 weeks
measure: Distress (i.e. depression)
timeFrame: 0, 8 and 12 weeks
measure: Fear of cancer progression
timeFrame: 0, 8 and 12 weeks
measure: Quality of sleep
timeFrame: 0, 8 and 12 weeks
measure: Health-related quality of life
timeFrame: 0, 8 and 12 weeks
measure: Change in distress (i.e. depression)
timeFrame: 0, 8 and 12 weeks
measure: Change in distress (i.e. anxiety)
timeFrame: 0, 8 and 12 weeks
measure: Change in fear of cancer progression
timeFrame: 0, 8 and 12 weeks
measure: Change in quality of sleep
timeFrame: 0, 8 and 12 weeks
measure: Change in health-related quality of life
timeFrame: 0, 8 and 12 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUMC
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord-Holland
Study officials:
References: