HYPNAYA Feasibility Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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AYA Cancer Patients

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medical Hypnosis<br>Study 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of hypnotherapy as supportive treatment for AYA patients | 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of included questionnaires | Feasibility of included questionnaires measured by the proportion of patients that complete all questionnaires pre-intervention (T0) and post-intervention (T3 and T4) | 0, 8 and 12 weeks | 
| Feasibility of self-hypnosis | Feasibility of self-hypnosis measured by the proportion of patients that weekly perform self-hypnosis exercises and use recorded scripts for self-hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy. | 8 and 12 weeks | 
| Patient-reported satisfaction of medical hypnosis | Patient-reported satisfaction of medical hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy. | 8 and 12 weeks | 
| Reach of medical hypnosis | Reach measured as the number of participants and non-participants from the eligible patient population. Both numbers are retrieved from the central study database completed by the study coordinator. | 1 year | 
| Distress (i.e. anxiety) | Distress (i.e. anxiety) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (8a) questionnaire (range 8 to 40, higher scores indicate higher level of anxiety). | 0, 8 and 12 weeks | 
| Distress (i.e. depression) | Distress (i.e. depression) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8a) questionnaire (range 8 to 40, higher scores indicate higher level of depression). | 0, 8 and 12 weeks | 
| Fear of cancer progression | Fear of cancer progression as assessed using the Cancer Worry Scale (CWS) questionnaire (range 6 to 24, higher scores indicate high fear of cancer recurrence). | 0, 8 and 12 weeks | 
| Quality of sleep | Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21), higher scores indicate worse sleep quality). | 0, 8 and 12 weeks | 
| Health-related quality of life | Health-related quality of life as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30, version 3.0) questionnaire (range 0 to 100, higher scores indicate better quality of life) | 0, 8 and 12 weeks | 
| Change in distress (i.e. depression) | Change in distress (i.e. depression) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (8a) questionnaire (range 8 to 40, higher scores indicate higher level of depression) pre-intervention (T0) and post-intervention (T3). | 0, 8 and 12 weeks | 
| Change in distress (i.e. anxiety) | Change in distress (i.e. anxiety) measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety (8a) questionnaire (range 8 to 40, higher scores indicate higher level of anxiety) pre-intervention (T0) and post-intervention (T3). | 0, 8 and 12 weeks | 
| Change in fear of cancer progression | Change in fear of cancer progression as assessed using the Cancer Worry Scale (CWS) questionnaire (range 6-24, higher score indicate high fear of cancer recurrence) pre-intervention (T0) and post-intervention (T3). | 0, 8 and 12 weeks | 
| Change in quality of sleep | Change in quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21, higher scores indicate worse sleep quality) pre-intervention (T0) and post-intervention (T3). | 0, 8 and 12 weeks | 
| Change in health-related quality of life | Change in health-related quality of life as assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30, version 3.0) measured by comparing outcomes of questionnaires (range 0 to 100, higher scores indicate better quality of life) pre-intervention (T0) and post-intervention (T3). | 0, 8 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Hypnosis