Pre- and post-operative psychological interventions to prevent pain and fatigue after breast cancer surgery (PREVENT): Protocol for a randomized controlled trial

Abstract

Background Breast cancer is the most common cancer type among women worldwide with over a million new cases each year. More than 40% of these women will struggle with chronic pain and fatigue after surgery, regardless of surgical procedure. These consequences are detrimental and result in distress and disability, including work disability. Few attempts have been made to prevent chronic pain and fatigue after surgery by applying a psychological approach, despite psychological risk factors being crucial in the development of both chronic pain and fatigue. In this study, we aim to develop and test an easily implementable strategy of preventing chronic pain and fatigue after breast cancer surgery. The intervention strategy involves a pre-operative hypnosis session and a web-based post-operative Acceptance and Commitment Therapy (ACT). The hypnosis has previously been found effective in alleviating acute post-operative pain and fatigue in breast cancer patients, while ACT is well suited to cancer populations as it offers a model of healthy adaptation to difficult circumstances. Together they form an intervention strategy with both a preventive and a rehabilitative focus. Methods/Design This randomized controlled trial aims to estimate the effects of the pre- and post- operative interventions compared to attentional control and treatment as usual (TAU) and will also include a qualitative process evaluation. Participants will be randomized to receive either a pre-operative brief hypnosis session and a post-operative web-based psychological intervention (iACT) or a pre-operative one-session mindfulness through an audio file and post-operative TAU. Self-reported questionnaire data and biomarker data will be assessed pre-surgery, post-surgery and 3 and 12 months after surgery. In addition, we will assess registry data on sick leave and prescriptions until 2-year follow-up. In the qualitative process evaluation, data will be collected from participants from both study arms (through interviews and a diary) and two different analyses performed (socio-narrative and Grounded Theory) with the objective to describe the development of chronic post-surgical pain and fatigue and the potential influence of the interventions on these processes. The study is set-up to demonstrate a minimum difference in pain of 1 point on NRS (0–10) and 3 points on FACIT-F (0–52) between the groups at 3-months follow-up by including 200 breast cancer patients in total. Discussion This trial will be the first study to estimate the effect of a combined pre-operative hypnosis with a post-operative iACT to prevent pain and fatigue after breast cancer surgery. The results from our study might i) help the large group of women affected by chronic pain and fatigue after breast cancer surgery, ii) shed light on the mechanisms involved in chronic pain and fatigue development, and iii) serve as a model for other surgical procedures. Trial registration Clinicaltrials.gov, registration number NCT04518085. Registered on January 29th, 2020. https://clinicaltrials.gov/ct2/show/NCT04518085.

Acute and subacute postsurgical pain in women with breast cancer: incidence and associations with biopsychosocial predictors—a secondary analysis of a randomized controlled trial

“…The study design of the PREVENT trial has been fully described and published in the protocol. 34 In brief, PREVENT investigated the effects of presurgical and postsurgical psychological interventions to prevent pain and fatigue after breast cancer surgery. Two hundred five women between 18 and 70 years who were scheduled to receive breast cancer surgery at the Department of Breast and Endocrine Surgery, Oslo University Hospital, Norway, were enrolled in the RCT between the 16th of October 2020 and the fourth of March 2022.…”

“…Patients randomized to the intervention group in the PREVENT trial received a 15-minute long hypnosis session delivered by a trained therapist approximately 1 hour before surgery. 34 …”

“…Patients randomized to the intervention group in the PREVENT trial received a 15-minute long hypnosis session delivered by a trained therapist approximately 1 hour before surgery. 34 At the Department of Breast and Endocrine Surgery at Oslo University Hospital, the perioperative procedure for women with breast cancer starts with multidisciplinary assessment and diagnosis. Patients were contacted by a patient coordinator by phone on the same day that the multidisciplinary team determined the patient's diagnosis.…”

Identifikasi Kebutuhan Psikoedukasi untuk Menurunkan Distres Psikologis pada Wanita dengan Kanker Payudara Pasca Mastektomi

“…Nyeri kronis dan kelelahan merupakan sensasi fisik yang paling banyak ditemukan pada wanita kanker payudara pasca mastektomi. Hal ini sesuai penelitian yang menunjukkan bahwa 40% wanita mengalami nyeri kronis dan kelelahan sehingga membutuhkan psikoedukasi (Reme et al, 2022a). Psikoedukasi dibutuhkan pada pasien kanker payudara yang memerlukan bantuan segera baik sebelum, sedang atau setelah prosedur medis untuk menerima, mentolerir, dan mengatasi pemikiran, emosi dan perilaku negatif (Izydorczyk et al, 2018).…”

“…Penelitian menunjukkan tingkat nyeri neuropatik pasca mastektomi dilaporkan 69,2% pada tingkat sedang -berat (Bibi et al, 2022). Nyeri kronis ini menetap 3 bulan setelah operasi, terlokalisasi dan bersifat neuropatik (Reme et al, 2022b), sedangkan kelelahan (fatigue) berlangsung selama 6 bulan atau lebih dengan tingkat kelelahan tinggi pada 2 bulan pertama, lalu kelelahan ringan -sedang pada 12 bulan setelah operasi (Reme et al, 2022a). Sensasi fisik lain ditemukan pada 48 jam setelah operasi yaitu pusing, batuk, sesak nafas, mual dan muntah (Susan W Wesmiller, et al, 2023).…”