Clinical trial · Interventional
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
NCT04518085CI-TRIAL-00072090PREVENTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internet-based Acceptance and Commitment Therapy (iACT) | Behavioral | — | UNRESOLVED |
| Medical hypnosis | Behavioral | — | UNRESOLVED |
| Mindfulness session | Behavioral | — | UNRESOLVED |
| Treatment as Usual (TAU) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypnosis + iACT
- description
- Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
- interventionNames
- Behavioral: Medical hypnosis
- Behavioral: Internet-based Acceptance and Commitment Therapy (iACT)
- type
- ACTIVE_COMPARATOR
- label
- Mindfulness + treatment as usual (TAU)
- description
- Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
- interventionNames
- Behavioral: Mindfulness session
- Behavioral: Treatment as Usual (TAU)
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with breast cancer and scheduled for surgery * Be able to provide informed consent Exclusion Criteria: * Insufficient Norwegian speaking or writing skills to participate in the interventions and fill out questionnaires * Cognitive and psychiatric impairment * Other serious malignancies
References
Publications (5)
- BACKGROUNDLind 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. PMID 34818921
- BACKGROUNDEngel 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. PMID 37352256
- BACKGROUNDMunk 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. PMID 36699993
- BACKGROUNDReme 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. PMID 35802618
- DERIVEDReme 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. PMID 41203018