NCT04518085

Psychological Interventions to Prevent Late Effects in Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: University of Oslo · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Fatigue
• Breast Cancer

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-03-03
• Completion: 2023-11-01
• First posted: 2020-08-19
• Last updated: 2023-12-08

Locations

1 site across 1 country: Norway