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.
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.
Study Type
OBSERVATIONAL
Enrollment
30
Amsterdam UMC, location VUMC
Amsterdam, North Holland, Netherlands
RECRUITINGAmsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands
RECRUITINGFeasibility 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.
Time frame: 8 weeks
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 0, 8 and 12 weeks