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Pain, PostoperativePREVENTNCT04518085

Psychological Interventions to Prevent Late Effects in Breast Cancer

A study testing Medical hypnosis, Internet-based Acceptance and Commitment Therapy (iACT) and Mindfulness session in people with Pain, Postoperative and Fatigue, run by University of Oslo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Pain, Postoperative, Fatigue, Breast Cancer
What is being tested?
Medical hypnosis, Internet-based Acceptance and Commitment Therapy (iACT) and Mindfulness session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
203 participants
Where
1 siteNorway
Study dates
1 Oct 2020to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women diagnosed with breast cancer and scheduled for surgery
  • Be able to provide informed consent

Who cannot join

  • Insufficient Norwegian speaking or writing skills to participate in the interventions and fill out questionnaires
  • Cognitive and psychiatric impairment
  • Other serious malignancies

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital (Aker Hospital)

    Oslo

Other trials in Norway

About this study

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

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.

Read the detailed description

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.

Being tested
Medical hypnosis, Internet-based Acceptance and Commitment Therapy (iACT), Mindfulness session, Treatment as Usual (TAU)
Keywords
Breast cancer, Post-surgical pain, Fatigue, Hypnosis, Acceptance and commitment therapy
Medical subject headings
Pain, Postoperative, Fatigue, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical hypnosisBehavioural

    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.

  • Internet-based Acceptance and Commitment Therapy (iACT)Behavioural

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

  • Mindfulness sessionBehavioural

    Single session mindfulness session delivered by audio file

  • Treatment as Usual (TAU)Behavioural

    Treatment as usual as part of post-surical care

Study groups in NCT04518085
Study groupRoleWhat they receive
Hypnosis + iACTExperimentalSingle 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
Receives: Behavioral: Medical hypnosis; Behavioral: Internet-based Acceptance and Commitment Therapy (iACT)
Mindfulness + treatment as usual (TAU)Active comparatorSingle 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
Receives: Behavioral: Mindfulness session; Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chronic post-surgical pain

    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: 3 months after surgery

  2. Post-surgical fatigue

    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: 3 months after surgery

Secondary outcomes (6)

  1. Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset

    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.

    Measured: On the day of surgery right before discharge

  2. Stress (immunological) reactivity

    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.

    Measured: Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline)

  3. Number of psychotropic and pain-related prescriptions

    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.

    Measured: 3 and 12 months post-surgery

  4. Number of sick leave days

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

    Measured: 3 and 12 months post-surgery

  5. Psychological flexibility

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

    Measured: 3 and 12 months post-surgery

  6. Psychological distress

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

    Measured: 3 and 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2020
  2. Study start1 Oct 2020
  3. Primary completion3 Mar 2022
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04518085
Sponsor's protocol ID
201906
Acronym
PREVENT
Status last verified
Dec 2023
First submitted
5 Aug 2020
Last updated
8 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Lind SB, Jacobsen HB, Solbakken OA, Reme SE. Clinical Hypnosis in Medical Care: A Mixed-Method Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058678. doi: 10.1177/15347354211058678.

    PubMed 34818921

  • Engel S, Jacobsen HB, Reme SE. A cross-sectional study of fear of surgery in female breast cancer patients: Prevalence, severity, and sources, as well as relevant differences among patients experiencing high, moderate, and low fear of surgery. PLoS One. 2023 Jun 23;18(6):e0287641. doi: 10.1371/journal.pone.0287641. eCollection 2023.

    PubMed 37352256

  • Munk A, Jacobsen HB, Schnur J, Montgomery G, Reme SE. Acute and subacute postsurgical pain in women with breast cancer: incidence and associations with biopsychosocial predictors-a secondary analysis of a randomized controlled trial. Pain Rep. 2023 Jan 10;8(1):e1058. doi: 10.1097/PR9.0000000000001058. eCollection 2023 Jan.

    PubMed 36699993

  • Reme SE, Munk A, Holter MTS, Falk RS, Jacobsen HB. Pre- and post-operative psychological interventions to prevent pain and fatigue after breast cancer surgery (PREVENT): Protocol for a randomized controlled trial. PLoS One. 2022 Jul 8;17(7):e0268606. doi: 10.1371/journal.pone.0268606. eCollection 2022.

    PubMed 35802618

  • Reme SE, Munk A, Montgomery GH, Schnur JB, Falk R, Smits M, Jacobsen HB. Preoperative Hypnosis versus Mindfulness for Reducing Postoperative Symptoms in Breast Surgery: A Randomized Clinical Trial. Anesthesiology. 2026 Mar 1;144(3):559-569. doi: 10.1097/ALN.0000000000005821. Epub 2025 Nov 7.

    PubMed 41203018

Questions about this trial

What is this clinical trial studying?

A study testing Medical hypnosis, Internet-based Acceptance and Commitment Therapy (iACT) and Mindfulness session in people with Pain, Postoperative and Fatigue, run by University of Oslo at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chronic post-surgical pain (time frame: 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04518085, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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