Clinical trial · Interventional
Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study
Optimization of Psychological Treatment for Pain After Breast Cancer Using the Multiphase Optimization Strategy (MOST): A Pilot Study
NCT04841928CI-TRIAL-00054195completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study is a pilot study that aims to evaluate the feasibility, validity, and preliminary efficacy of three psychological treatment components for pain after breast cancer, which will be evaluated in a larger trial following completion of the present pilot study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain, Chronic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decentering | Behavioral | — | UNRESOLVED |
| Mindful attention | Behavioral | — | UNRESOLVED |
| Value-based action | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- NO_INTERVENTION
- label
- Waitlist control
- description
- Participants randomized to condition 1 are not offered any treatment components immediately upon enrollment, but will be offered a treatment component of own choice at the end of the study. Total number of sessions: 2 (2 contact hours) following study completion.
- type
- EXPERIMENTAL
- label
- Mindful attention
- description
- Participants randomized to condition 2 will receive the Mindful attention treatment component. Total number of sessions: 2 (2 contact hours).
- interventionNames
- Behavioral: Mindful attention
- type
- EXPERIMENTAL
- label
- Decentering
- description
- Participants randomized to condition 3 will receive the Decentering treatment component. Total number of sessions: 2 (2 contact hours).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: * Diagnosis of primary breast cancer stage I-III * Min. 6 months post breast cancer treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozole or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation * Pain corresponding to a min. pain score of \>= 3 on pain intensity or pain interference measured by 11-point Numeric Rating Scales (NRSs) * Sufficient ability to communicate in Danish * Sufficient ability to participate in an online-delivered intervention Exclusion Criteria: * Metastatic breast cancer (stage IV) * Breast cancer recurrence * Bilateral breast cancer * Other current cancer disease * Other current pain condition (e.g., fibromyalgia) * Current severe psychiatric disorder (e.g., psychosis) * Inability to communicate in Danish * Inability to participate in an online-delivered intervention
References
Publications (1)
- DERIVEDBuskbjerg CR, Johannsen M, Norskov CC, Jensen AB, Frederiksen Y, Egerod I, Guastaferro K, Johansen C, von Heymann A, Speckens A, O'Toole MS, Zachariae R. Optimizing Psychological Treatment for Pain After Breast Cancer Using a Randomized Factorial Design: A Feasibility Study. Scand J Psychol. 2026 Jun;67(3):771-786. doi: 10.1111/sjop.70063. Epub 2025 Dec 31. PMID 41474052