Breast Cancer, Fatigue, Pain, Postoperative
Conditions
Keywords
Breast cancer, Post-surgical pain, Fatigue, Hypnosis, Acceptance and commitment therapy
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.
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.
Interventions
BEHAVIORALMedical 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.
BEHAVIORALInternet-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
BEHAVIORALMindfulness session
Single session mindfulness session delivered by audio file
BEHAVIORALTreatment as Usual (TAU)
Treatment as usual as part of post-surical care
Sponsors
Oslo University Hospital
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic post-surgical pain | 3 months after surgery | 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. |
| Post-surgical fatigue | 3 months after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of psychotropic and pain-related prescriptions | 3 and 12 months post-surgery | 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. |
| Number of sick leave days | 3 and 12 months post-surgery | Days away from work on sick leave will be measured through registry data |
| Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset | On the day of surgery right before discharge | 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. |
| Psychological distress | 3 and 12 months post-surgery | Measured through the Hospital Anxiety and Depression Scale (HADS). The total score ranges from 0-42, where a higher score indicates more symptoms |
| Psychological flexibility | 3 and 12 months post-surgery | Measured through the Acceptance and Action Questionnaire (AAQ-II). The scale ranges from 7-49, where higher score indicates more psychological inflexibility |
| Stress (immunological) reactivity | Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline) | 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. |
Countries
Norway
Outcome results
None listed