- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06021093
HYPNAYA Feasibility Study
HYPNotherapy for Improving Distress and Sleep in Adolescents and Young Adults With Cancer; a Feasibility Study (HYPNAYA Feasibility Study)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Noord-Holland
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Amsterdam, Noord-Holland, Netherlands, 1105AZ
- Recruiting
- Amsterdam UMC, location AMC
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Contact:
- Jacqueline M Tromp, MD, PhD
- Phone Number: +31-(0)20-7328149
- Email: j.m.tromp@amsterdamumc.nl
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Contact:
- Jasper LA Vleugels, MD, PhD
- Phone Number: +31-(0)625011785
- Email: j.l.vleugels@amsterdamumc.nl
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Amsterdam, Noord-Holland, Netherlands, 1081HV
- Recruiting
- Amsterdam UMC, location VUMc
-
Contact:
- Jacqueline M Tromp, MD, PhD
- Phone Number: +31-(0)20-7328149
- Email: j.m.tromp@amsterdamumc.nl
-
Contact:
- Jasper LA Vleugels, MD, PhD
- Phone Number: +31-(0)62501178
- Email: j.l.vleugels@amsterdamumc.nl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Medical Hypnosis
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?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of hypnotherapy as supportive treatment for AYA patients
Time Frame: 8 weeks
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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.
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of included questionnaires
Time Frame: 0, 8 and 12 weeks
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Feasibility of included questionnaires measured by the proportion of patients that complete all questionnaires pre-intervention (T0) and post-intervention (T3 and T4)
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0, 8 and 12 weeks
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Feasibility of self-hypnosis
Time Frame: 8 and 12 weeks
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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.
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8 and 12 weeks
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Patient-reported satisfaction of medical hypnosis
Time Frame: 8 and 12 weeks
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Patient-reported satisfaction of medical hypnosis measured using a structured exit interview on the experiences with medical hypnotherapy.
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8 and 12 weeks
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Reach of medical hypnosis
Time Frame: 1 year
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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.
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1 year
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Distress (i.e. anxiety)
Time Frame: 0, 8 and 12 weeks
|
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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0, 8 and 12 weeks
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Distress (i.e. depression)
Time Frame: 0, 8 and 12 weeks
|
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).
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0, 8 and 12 weeks
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Fear of cancer progression
Time Frame: 0, 8 and 12 weeks
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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).
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0, 8 and 12 weeks
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Quality of sleep
Time Frame: 0, 8 and 12 weeks
|
Quality of sleep as assessed by the Pittsburgh Sleep Quality Index (PSQI) questionnaire (range 0 to 21), higher scores indicate worse sleep quality).
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0, 8 and 12 weeks
|
Health-related quality of life
Time Frame: 0, 8 and 12 weeks
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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)
Time Frame: 0, 8 and 12 weeks
|
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
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Change in distress (i.e. anxiety)
Time Frame: 0, 8 and 12 weeks
|
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
Time Frame: 0, 8 and 12 weeks
|
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
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Change in quality of sleep
Time Frame: 0, 8 and 12 weeks
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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
Time Frame: 0, 8 and 12 weeks
|
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
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL83528.018.23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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