Spots Global Cancer Trial Database for Psychological Interventions to Prevent Late Effects in Breast Cancer

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Trial Identification

Brief Title: Psychological Interventions to Prevent Late Effects in Breast Cancer

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

Study ID: NCT04518085

Conditions

Pain, Postoperative

Fatigue

Breast Cancer

Interventions

Medical hypnosis

Internet-based Acceptance and Commitment Therapy (iACT)

Mindfulness session

Treatment as Usual (TAU)

Study Description

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.