Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark
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...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/3/e066505.full |
| _version_ | 1797744293619695616 |
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| author | Anders Bonde Jensen Christoffer Johansen Anne Speckens Annika von Heymann Yoon Frederiksen Robert Zachariae Cecilie Buskbjerg Mia Skytte O'Toole Maja Johannsen |
| author_facet | Anders Bonde Jensen Christoffer Johansen Anne Speckens Annika von Heymann Yoon Frederiksen Robert Zachariae Cecilie Buskbjerg Mia Skytte O'Toole Maja Johannsen |
| author_sort | Anders Bonde Jensen |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-03-12T15:07:40Z |
| format | Article |
| id | doaj.art-ce9360c709cc41ab8ce6488ec687b71a |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:07:40Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-ce9360c709cc41ab8ce6488ec687b71a2023-08-12T07:45:07ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-066505Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in DenmarkAnders Bonde Jensen0Christoffer Johansen1Anne Speckens2Annika von Heymann3Yoon Frederiksen4Robert Zachariae5Cecilie Buskbjerg6Mia Skytte O'Toole7Maja Johannsen8Department of Oncology, Aarhus University Hospital, Aarhus, DenmarkCASTLE Cancer Late Effects Research Unit, Department of Oncology, Copenhagen University Hospital, Copenhagen, DenmarkDepartment of Psychiatry, Centre for Mindfulness, Radboud University Medical Center, Nijmegen, The NetherlandsCASTLE Cancer Late Effects Research Unit, Department of Oncology, Copenhagen University Hospital, Copenhagen, DenmarkDeparment of Clinical Medicine, Aarhus University Hospital, Aarhus, DenmarkDepartment of Psychology and Behavioural Sciences, Aarhus University, Aarhus, DenmarkDepartment of Psychology and Behavioural Sciences, Aarhus University, Aarhus, DenmarkDepartment of Psychology and Behavioural Sciences, Aarhus University, Aarhus, DenmarkDepartment of Psychology and Behavioural Sciences, Aarhus University, Aarhus, DenmarkIntroduction 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).https://bmjopen.bmj.com/content/13/3/e066505.full |
| spellingShingle | Anders Bonde Jensen Christoffer Johansen Anne Speckens Annika von Heymann Yoon Frederiksen Robert Zachariae Cecilie Buskbjerg Mia Skytte O'Toole Maja Johannsen Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark BMJ Open |
| title | Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark |
| title_full | Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark |
| title_fullStr | Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark |
| title_full_unstemmed | Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark |
| title_short | Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark |
| title_sort | optimising psychological treatment for pain after breast cancer a factorial design study protocol in denmark |
| url | https://bmjopen.bmj.com/content/13/3/e066505.full |
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