Psychological Interventions to Prevent Late Effects in Breast Cancer

Not Applicable

Completed

• Conditions: Pain, Postoperative; Breast Cancer; Fatigue
• Interventions: Behavioral: Medical hypnosis; Behavioral: Mindfulness session; Behavioral: Treatment as Usual (TAU); Behavioral: Internet-based Acceptance and Commitment Therapy (iACT)

• Registration Number: NCT04518085
• Lead Sponsor: University of Oslo

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 Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-19
• Study Start: 2020-10-01
• Primary Completion: 2022-03-03
• Study Completion: 2023-11-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness + treatment as usual (TAU)	Treatment as Usual (TAU)	Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
Hypnosis + iACT	Medical hypnosis	Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
Hypnosis + iACT	Internet-based Acceptance and Commitment Therapy (iACT)	Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
Mindfulness + treatment as usual (TAU)	Mindfulness session	Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery

Primary Outcome Measures

Name	Time	Method
Post-surgical fatigue	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	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 Outcome Measures

Name	Time	Method
Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset	On the day of surgery right before discharge	Measured by a Visual Analogue Scale (VAS) (to replicate a previous hypnosis trial - Montgomery et al 2007). The range is 0-100 where a higher score indicates more intense symptoms.
Number of psychotropic and pain-related prescriptions	3 and 12 months post-surgery	Usage of psychotropic and pain medication obtained through registry data from the Norwegian Prescription Database at 3 and 12 months follow-up. Number of prescriptions will be summarized and compared between intervention and control group.
Stress (immunological) reactivity	Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline)	Immune function is assessed through whole blood samples using the standardized TruCulture system that contains immunogenic stimuli (infected tubes). This test will reveal the induced innate and adaptive immune response in whole blood after stimulation with LPS, by quantifying the release of soluble immune activation products (cytokines, chemokines, soluble receptors etc.) in the supernatant and by measuring the transcription level (mRNA) in the circulating blood (immune) cells.
Number of sick leave days	3 and 12 months post-surgery	Days away from work on sick leave will be measured through registry data
Psychological flexibility	3 and 12 months post-surgery	Measured through the Acceptance and Action Questionnaire (AAQ-II). The scale ranges from 7-49, where higher score indicates more psychological inflexibility
Psychological distress	3 and 12 months post-surgery	Measured through the Hospital Anxiety and Depression Scale (HADS). The total score ranges from 0-42, where a higher score indicates more symptoms

Trial Locations

Locations (1)

Oslo University Hospital (Aker Hospital); 🇳🇴 Oslo, Norway