Psychological Interventions to Prevent Late Effects in Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Postoperative, Fatigue, Breast Cancer

Intervention / Treatment
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* Behavioral: Medical hypnosis
* Behavioral: Internet-based Acceptance and Commitment Therapy (iACT)
* Behavioral: Mindfulness session
* Behavioral: Treatment as Usual (TAU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis + iACT<br>Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery | Behavioral: Medical hypnosis<br>* 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.<br>Behavioral: Internet-based Acceptance and Commitment Therapy (iACT)<br>* Access to an online platform developed to this study containing video clips and audio files with ACT consistent material<br>|
| Active Comparator: Mindfulness + treatment as usual (TAU)<br>Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery | Behavioral: Mindfulness session<br>* Single session mindfulness session delivered by audio file<br>Behavioral: Treatment as Usual (TAU)<br>* Treatment as usual as part of post-surical care<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and commitment therapy, Breast cancer, Post-surgical pain, Fatigue, Hypnosis