Psychological Interventions to Prevent Late Effects in Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- Fatigue
- Pain Postoperative
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.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.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Only males
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 ac...
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.
Tracking Information
- NCT #
- NCT04518085
- 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
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