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.

Jacqueline M Tromp, MD, PhD

Jasper LA Vleugels, MD, PhD

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.

HYPNAYA Feasibility Study

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

No specific plans but open to interested colleagues/persons

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.

Feasibility of included questionnaires measured by the proportion of patients that complete all questionnaires pre-intervention (T0) and post-intervention (T3 and T4)

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.

Patient-reported satisfaction of medical hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy.

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.

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).

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).

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).

Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21), higher scores indicate worse sleep quality).

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)

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).

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).

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).

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).

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).

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

Principal Investigator

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Fatigue

Breast Neoplasms

Pain, Postoperative

Pain

Breast Diseases

Skin Diseases

Postoperative Complications

Neurologic Manifestations

Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery

Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery

Single session 20 minutes hypnosis session originally developed and tested by Montgomery et al. (2007) in a similar setting. Delivered by an experienced clinical psychologist.

Medical hypnosis

Access to an online platform developed to this study containing video clips and audio files with ACT consistent material

Internet-based Acceptance and Commitment Therapy (iACT)

Single session mindfulness session delivered by audio file

Mindfulness session

Treatment as usual as part of post-surical care

Treatment as Usual (TAU)

Silje E Reme, PhD

Henrik B Jacobsen, PhD

The study aims to investigate whether a combined pre-operative medical hypnosis plus a post-operative internet-based acceptance and commitment intervention are more effective in preventing post-surgical pain and fatigue following breast cancer surgery compared with pre-operative mindfulness plus treatment as usual.

The trial will include 200 patients undergoing breast cancer surgery at Oslo University Hospital. The patients will be randomized into two groups. One group will receive a 20 minute pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a post-surgical internet-based acceptance and commitment intervention. The control group will receive a 20 minute pre-surgical mindfulness session delivered through an audio recording plus treatment as usual. The primary outcomes of the study are quantitative measures of post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples. The study uses a longitudinal design with baseline measures obtained pre-surgery and follow up measures obtained 3 and 12 months post-surgery.

Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.

The intervention group vs. active control group status will be known to the participants and the health care personnel delivering the interventions. However, the investigator, outcome assessor and the additional health care personnel at the unit will be masked to the conditions.

Eligible participants are women (biological sex) diagnosed with breast cancer

Psychological Interventions to Prevent Late Effects in Breast Cancer

Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial

The study protocol, along with the intervention protocols, will all be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, data files involving questionnaire and biomarker data will be made available upon reasonable request. Due to privacy concerns, the complete data files will not be shared online.

Measured through a Numeric Rating Scale (NRS) for pain intensity. The scale ranges from 0-10, anchored by verbal descriptors at either end of the scale where 0 is no pain at all and 10 is the worst possible pain.

Measured through the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F) which is a unidimensional self-report scale to assess fatigue and its impact on daily life. The score range is 0-52 where a higher score indicates better quality of life (i.e. less symptoms and disability)

Measured by a Visual Analogue Scale (VAS) (to replicate a previous hypnosis trial - Montgomery et al 2007). The range is 0-100 where a higher score indicates more intense symptoms.

Immune function is assessed through whole blood samples using the standardized TruCulture system that contains immunogenic stimuli (infected tubes). This test will reveal the induced innate and adaptive immune response in whole blood after stimulation with LPS, by quantifying the release of soluble immune activation products (cytokines, chemokines, soluble receptors etc.) in the supernatant and by measuring the transcription level (mRNA) in the circulating blood (immune) cells.

Usage of psychotropic and pain medication obtained through registry data from the Norwegian Prescription Database at 3 and 12 months follow-up. Number of prescriptions will be summarized and compared between intervention and control group.

Days away from work on sick leave will be measured through registry data

Measured through the Acceptance and Action Questionnaire (AAQ-II). The scale ranges from 7-49, where higher score indicates more psychological inflexibility

Measured through the Hospital Anxiety and Depression Scale (HADS). The total score ranges from 0-42, where a higher score indicates more symptoms

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HYPNAYA Feasibility Study	NCT06021093	AYA Cancer Pati...		18 Years - 39 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
HYPNAYA Feasibility Study	NCT06021093	AYA Cancer Pati...		18 Years - 39 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Psychological Interventions to Prevent Late Effects in Breast Cancer	NCT04518085	Pain, Postopera... Fatigue Breast Cancer	Medical hypnosi... Internet-based ... Mindfulness ses... Treatment as Us...	18 Years - 70 Years	University of Oslo
Psychological Interventions to Prevent Late Effects in Breast Cancer	NCT04518085	Pain, Postopera... Fatigue Breast Cancer	Medical hypnosi... Internet-based ... Mindfulness ses... Treatment as Us...	18 Years - 70 Years	University of Oslo

Spots Global Cancer Trial Database for medical hypnosis