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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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.|
|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|
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
- 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.
- 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)
- 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.
- 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.
- 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.
- 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
- 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
- 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
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
|Contact: Silje E Reme, PhDfirstname.lastname@example.org|
|Contact: Henrik B Jacobsen, PhDemail@example.com|
|Principal Investigator:||Silje E Reme, PhD||University of Oslo + Oslo University Hospital|
|Principal Investigator:||Henrik B Jacobsen, PhD||University of Oslo + Oslo University Hospital|