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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Breast Cancer; Fatigue
• Intervention / Treatment: Behavioral: Medical hypnosis; Behavioral: Internet-based Acceptance and Commitment Therapy (iACT); Behavioral: Mindfulness session; Behavioral: Treatment as Usual (TAU)

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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital (Aker Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnosis + iACT; Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery	Behavioral: 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.; Behavioral: 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
Active Comparator: Mindfulness + treatment as usual (TAU); Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery	Behavioral: Mindfulness session; Single session mindfulness session delivered by audio file; Behavioral: Treatment as Usual (TAU); Treatment as usual as part of post-surical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	On the day of surgery right before discharge
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.	Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline)
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.	3 and 12 months post-surgery
Number of sick leave days	Days away from work on sick leave will be measured through registry data	3 and 12 months post-surgery
Psychological flexibility	Measured through the Acceptance and Action Questionnaire (AAQ-II). The scale ranges from 7-49, where higher score indicates more psychological inflexibility	3 and 12 months post-surgery
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	3 and 12 months post-surgery

Collaborators and Investigators

• Sponsor: University of Oslo
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: Silje E Reme, PhD, University of Oslo + Oslo University Hospital; Principal Investigator: Henrik B Jacobsen, PhD, University of Oslo + Oslo University Hospital

Publications and helpful links

General 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.
• 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.

Helpful Links

• Project web page

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Fatigue; Breast cancer; Hypnosis; Acceptance and commitment therapy; Post-surgical pain
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms; Fatigue
• Other Study ID Numbers: 201906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Data files involving self-report data will be shared upon reasonable request when the main analyses are completed and published.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No