Psychological Interventions to Prevent Late Effects in Breast Cancer
NCT ID: NCT04518085
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
203 participants
INTERVENTIONAL
2020-10-01
2023-11-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Hypnosis + iACT
Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
Medical hypnosis
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)
Access to an online platform developed to this study containing video clips and audio files with ACT consistent material
Mindfulness + treatment as usual (TAU)
Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
Mindfulness session
Single session mindfulness session delivered by audio file
Treatment as Usual (TAU)
Treatment as usual as part of post-surical care
Interventions
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Medical hypnosis
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)
Access to an online platform developed to this study containing video clips and audio files with ACT consistent material
Mindfulness session
Single session mindfulness session delivered by audio file
Treatment as Usual (TAU)
Treatment as usual as part of post-surical care
Eligibility Criteria
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Inclusion Criteria
* Be able to provide informed consent
Exclusion Criteria
* Cognitive and psychiatric impairment
* Other serious malignancies
18 Years
70 Years
FEMALE
No
Sponsors
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Oslo University Hospital
OTHER
University of Oslo
OTHER
Responsible Party
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Silje Endresen Reme
Professor
Principal Investigators
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Silje E Reme, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo + Oslo University Hospital
Henrik B Jacobsen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo + Oslo University Hospital
Locations
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Oslo University Hospital (Aker Hospital)
Oslo, , Norway
Countries
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References
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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.
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.
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.
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.
Related Links
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Other Identifiers
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201906
Identifier Type: -
Identifier Source: org_study_id