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Trial record 1 of 1 for:    NCT04518085 | breast cancer
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Psychological Interventions to Prevent Late Effects in Breast Cancer (PREVENT)

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ClinicalTrials.gov Identifier: NCT04518085
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Silje Endresen Reme, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Fatigue Breast Cancer Behavioral: Medical hypnosis Behavioral: Internet-based Acceptance and Commitment Therapy (iACT) Behavioral: Mindfulness session Behavioral: Treatment as Usual (TAU) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The intervention group vs. active control group status will be known to the participants and the health care personnel delivering the interventions. However, the investigator, outcome assessor and the additional health care personnel at the unit will be masked to the conditions.
Primary Purpose: Prevention
Official Title: Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypnosis + iACT
Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery
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

Active Comparator: Mindfulness + treatment as usual (TAU)
Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligible participants are women (biological sex) diagnosed with breast cancer
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518085


Contacts
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Contact: Silje E Reme, PhD 004722845236 s.e.reme@psykologi.uio.no
Contact: Henrik B Jacobsen, PhD h.b.jacobsen@psykologi.uio.no

Locations
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Norway
Oslo University Hospital (Aker Hospital) Recruiting
Oslo, Norway
Contact: Vibeke Schou Jensen, RN    22894181    VIBJEN@ous-hf.no   
Contact: May-Britt Svanevik, RN    22894181    MAYSVA@ous-hf.no   
Sponsors and Collaborators
University of Oslo
Oslo University Hospital
Investigators
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Principal Investigator: Silje E Reme, PhD University of Oslo + Oslo University Hospital
Principal Investigator: Henrik B Jacobsen, PhD University of Oslo + Oslo University Hospital
Additional Information:
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Responsible Party: Silje Endresen Reme, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT04518085    
Other Study ID Numbers: 201906
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The study protocol, along with the intervention protocols, will all be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, data files involving questionnaire and biomarker data will be made available upon reasonable request. Due to privacy concerns, the complete data files will not be shared online.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The study protocol will be published as soon as possible. The intervention protocols will be publicly available upon study completion. Data files will be made available when the main analyses are completed, in 2025 at the latest.
Access Criteria: Data files involving self-report data will be shared upon reasonable request when the main analyses are completed and published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Silje Endresen Reme, University of Oslo:
Breast cancer
Post-surgical pain
Fatigue
Hypnosis
Acceptance and commitment therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Fatigue
Pain, Postoperative
Skin Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations