Psychological Interventions to Prevent Late Effects in Breast Cancer
PREVENT
Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial
1 other identifier
interventional
203
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 5, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedDecember 8, 2023
December 1, 2023
1.4 years
August 5, 2020
December 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
3 months after surgery
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)
3 months after surgery
Secondary Outcomes (6)
Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset
On the day of surgery right before discharge
Stress (immunological) reactivity
Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline)
Number of psychotropic and pain-related prescriptions
3 and 12 months post-surgery
Number of sick leave days
3 and 12 months post-surgery
Psychological flexibility
3 and 12 months post-surgery
- +1 more secondary outcomes
Study Arms (2)
Hypnosis + iACT
EXPERIMENTALSingle 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
Mindfulness + treatment as usual (TAU)
ACTIVE COMPARATORSingle 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
Interventions
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.
Access to an online platform developed to this study containing video clips and audio files with ACT consistent material
Single session mindfulness session delivered by audio file
Treatment as usual as part of post-surical care
Eligibility Criteria
You may qualify if:
- Women diagnosed with breast cancer and scheduled for surgery
- Be able to provide informed consent
You may not qualify if:
- Insufficient Norwegian speaking or writing skills to participate in the interventions and fill out questionnaires
- Cognitive and psychiatric impairment
- Other serious malignancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oslolead
- Oslo University Hospitalcollaborator
Study Sites (1)
Oslo University Hospital (Aker Hospital)
Oslo, Norway
Related Publications (4)
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.
PMID: 34818921BACKGROUNDEngel 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: 37352256BACKGROUNDMunk 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: 36699993BACKGROUNDReme 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: 35802618BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Silje E Reme, PhD
University of Oslo + Oslo University Hospital
- PRINCIPAL INVESTIGATOR
Henrik B Jacobsen, PhD
University of Oslo + Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The intervention group vs. active control group status will be known to the participants and the health care personnel delivering the interventions. However, the investigator, outcome assessor and the additional health care personnel at the unit will be masked to the conditions.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 5, 2020
First Posted
August 19, 2020
Study Start
October 1, 2020
Primary Completion
March 3, 2022
Study Completion
November 1, 2023
Last Updated
December 8, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The study protocol will be published as soon as possible. The intervention protocols will be publicly available upon study completion. Data files will be made available when the main analyses are completed, in 2025 at the latest.
- Access Criteria
- Data files involving self-report data will be shared upon reasonable request when the main analyses are completed and published.
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.