Psychological Interventions to Prevent Late Effects in Breast Cancer (PREVENT)

University of Oslo

Status: Completed

Conditions: Breast Cancer; Pain, Postoperative; Fatigue

Treatments: Behavioral: Treatment as Usual (TAU); Behavioral: Medical hypnosis; Behavioral: Internet-based Acceptance and Commitment Therapy (iACT); Behavioral: Mindfulness session

Study type: Interventional

Funder types: Other

Identifiers

NCT04518085

201906

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 2 patient groups

Hypnosis + iACT

Experimental group

Description:

Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery

Treatment:

Behavioral: Internet-based Acceptance and Commitment Therapy (iACT)

Behavioral: Medical hypnosis

Mindfulness + treatment as usual (TAU)

Active Comparator group

Description:

Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery

Treatment:

Behavioral: Treatment as Usual (TAU)

Behavioral: Mindfulness session