Clinical trial · Interventional
Optimizing Psychological Treatment for Pain After Breast Cancer
Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study
NCT05444101CI-TRIAL-00061895unknownN/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 aims to optimize psychological treatment for pain after breast cancer by identifying active treatment components. Specifically, a factorial design will be used to evaluate the efficacy and change processes of three psychological treatment components, which have been shown to be efficacious in the treatment of pain after breast cancer.
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 |
| Values and committed 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 primary treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozol or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation * Pain corresponding to a pain score of \>= 3 on pain intensity and/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: * Non-curable breast cancer (stage IV) * Breast cancer recurrence * Bilateral breast cancer * Other current cancer disease * Other primary pain condition (e.g., fibromyalgia) * Current severe psychiatric disorder (e.g., psychosis) hindering study participation * Insufficient ability to communicate in Danish * Insufficient ability to participate in an online-delivered intervention
References
Publications (1)
- DERIVEDBuskbjerg C, O'Toole MS, Zachariae R, Jensen AB, Frederiksen Y, Johansen C, von Heymann A, Speckens A, Johannsen M. Optimising psychological treatment for pain after breast cancer: a factorial design study protocol in Denmark. BMJ Open. 2023 Mar 22;13(3):e066505. doi: 10.1136/bmjopen-2022-066505. PMID 36948567