TY - JOUR
T1 - Optimising psychological treatment for pain after breast cancer
T2 - a factorial design study protocol in Denmark
AU - Buskbjerg, Cecilie
AU - O'Toole, Mia Skytte
AU - Zachariae, Robert
AU - Jensen, Anders Bonde
AU - Frederiksen, Yoon
AU - Johansen, Christoffer
AU - von Heymann, Annika
AU - Speckens, Anne
AU - Johannsen, Maja
N1 - © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023/3/22
Y1 - 2023/3/22
N2 - INTRODUCTION: One in five breast cancer (BC) survivors are affected by persistent pain years after completing primary treatment. While the efficacy of psychological interventions for BC-related pain has been documented in several meta-analyses, reported effect sizes are generally modest, pointing to a need for optimisation. Guided by the Multiphase Optimization Strategy, the present study aims to optimise psychological treatment for BC-related pain by identifying active treatment components in a full factorial design.METHODS AND ANALYSIS: The study uses a 2×3 factorial design, randomising 192 women with BC-related pain (18-75 years) to eight experimental conditions. The eight conditions consist of three contemporary cognitive-behavioural therapy components, namely: (1) mindful attention, (2) decentring, and (3) values and committed action. Each component is delivered in two sessions, and each participant will receive either zero, two, four or six sessions. Participants receiving two or three treatment components will be randomised to receive them in varying order. Assessments will be conducted at baseline (T1), session by session, every day for 6 days following the first session in each treatment component, at post-intervention (T2) and at 12-week follow-up (T3). Primary outcomes are pain intensity (Numerical Rating Scale) and pain interference (Brief Pain Inventory interference subscale) from T1 to T2. Secondary outcomes are pain burden, pain quality, pain frequency, pain catastrophising, psychological distress, well-being and fear of cancer recurrence. Possible mediators include mindful attention, decentring, and pain acceptance and activity engagement. Possible moderators are treatment expectancy, treatment adherence, satisfaction with treatment and therapeutic alliance.ETHICS AND DISSEMINATION: Ethical approval for the present study was received from the Central Denmark Region Committee on Health Research Ethics (no: 1-10-72-309-40). Findings will be made available to the study funders, care providers, patient organisations and other researchers at international conferences, and published in international, peer-reviewed journals.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05444101).
AB - INTRODUCTION: One in five breast cancer (BC) survivors are affected by persistent pain years after completing primary treatment. While the efficacy of psychological interventions for BC-related pain has been documented in several meta-analyses, reported effect sizes are generally modest, pointing to a need for optimisation. Guided by the Multiphase Optimization Strategy, the present study aims to optimise psychological treatment for BC-related pain by identifying active treatment components in a full factorial design.METHODS AND ANALYSIS: The study uses a 2×3 factorial design, randomising 192 women with BC-related pain (18-75 years) to eight experimental conditions. The eight conditions consist of three contemporary cognitive-behavioural therapy components, namely: (1) mindful attention, (2) decentring, and (3) values and committed action. Each component is delivered in two sessions, and each participant will receive either zero, two, four or six sessions. Participants receiving two or three treatment components will be randomised to receive them in varying order. Assessments will be conducted at baseline (T1), session by session, every day for 6 days following the first session in each treatment component, at post-intervention (T2) and at 12-week follow-up (T3). Primary outcomes are pain intensity (Numerical Rating Scale) and pain interference (Brief Pain Inventory interference subscale) from T1 to T2. Secondary outcomes are pain burden, pain quality, pain frequency, pain catastrophising, psychological distress, well-being and fear of cancer recurrence. Possible mediators include mindful attention, decentring, and pain acceptance and activity engagement. Possible moderators are treatment expectancy, treatment adherence, satisfaction with treatment and therapeutic alliance.ETHICS AND DISSEMINATION: Ethical approval for the present study was received from the Central Denmark Region Committee on Health Research Ethics (no: 1-10-72-309-40). Findings will be made available to the study funders, care providers, patient organisations and other researchers at international conferences, and published in international, peer-reviewed journals.TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05444101).
KW - Female
KW - Humans
KW - Breast Neoplasms/complications
KW - Chronic Pain/therapy
KW - Cognitive Behavioral Therapy/methods
KW - Denmark
KW - Neoplasm Recurrence, Local
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
UR - http://www.scopus.com/inward/record.url?scp=85150800906&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-066505
DO - 10.1136/bmjopen-2022-066505
M3 - Journal article
C2 - 36948567
SN - 2044-6055
VL - 13
SP - e066505
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e066505
ER -