Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oslo
- Enrollment
- 203
- Locations
- 1
- Primary Endpoint
- Post-surgical fatigue
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Hypnosis + iACT
Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
Intervention: Medical hypnosis (Behavioral)
Hypnosis + iACT
Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
Intervention: Internet-based Acceptance and Commitment Therapy (iACT) (Behavioral)
Mindfulness + treatment as usual (TAU)
Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
Intervention: Mindfulness session (Behavioral)
Mindfulness + treatment as usual (TAU)
Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
Intervention: Treatment as Usual (TAU) (Behavioral)
Outcomes
Primary Outcomes
Post-surgical fatigue
Time Frame: 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)
Chronic post-surgical pain
Time Frame: 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.
Secondary Outcomes
- Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset(On the day of surgery right before discharge)
- Number of psychotropic and pain-related prescriptions(3 and 12 months post-surgery)
- Stress (immunological) reactivity(Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline))
- Number of sick leave days(3 and 12 months post-surgery)
- Psychological flexibility(3 and 12 months post-surgery)
- Psychological distress(3 and 12 months post-surgery)
Investigators
Silje Endresen Reme
Professor
University of Oslo