NCT06021093

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

August 23, 2023

Last Update Submit

September 2, 2023

Conditions

AYA Cancer Patients

Keywords

Medical Hypnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Feasibility of included questionnaires

    0, 8 and 12 weeks

  • Feasibility of self-hypnosis

    8 and 12 weeks

  • Patient-reported satisfaction of medical hypnosis

    8 and 12 weeks

  • Reach of medical hypnosis

    1 year

  • Distress (i.e. anxiety)

    0, 8 and 12 weeks

  • +9 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Amsterdam UMC, location VUMC

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 1, 2023

Study Start

July 17, 2023

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

NL(2)