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Completed

NCT Number: NCT04518085

Psychological Interventions to Prevent Late Effects in Breast Cancer

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.

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Key information

Conditions

Pain, Postoperative Breast Cancer Breast Diseases Breast Neoplasms Fatigue Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital (Aker Hospital)

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical hypnosis

Behavioral

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.

Internet-based Acceptance and Commitment Therapy (iACT)

Behavioral

Access to an online platform developed to this study containing video clips and audio files with ACT consistent material

Mindfulness session

Behavioral

Single session mindfulness session delivered by audio file

Treatment as Usual (TAU)

Behavioral

Treatment as usual as part of post-surical care

Primary outcomes

  1. Chronic post-surgical pain

    Time frame: 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.

  2. Post-surgical fatigue

    Time frame: 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)

Secondary outcomes

  1. Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset

    Time frame: 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.

  2. Stress (immunological) reactivity

    Time frame: 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.

  3. Number of psychotropic and pain-related prescriptions

    Time frame: 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.

  4. Number of sick leave days

    Time frame: 3 and 12 months post-surgery

    Days away from work on sick leave will be measured through registry data

  5. Psychological flexibility

    Time frame: 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

  6. Psychological distress

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Acronym: PREVENT

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 19, 2020
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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