Clinical trial · Interventional
Optimized Rehabilitation Following Primary Breast Cancer Surgery
Optimized Rehabilitation Following Primary Breast Cancer Surgery - Systematic Screening as a Tool for Individualised Rehabilitation: Study Protocol for the RE-SCREEN Randomized Controlled Trial
- 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)
This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation .
Conditions
Conditions (3)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Psychological Distress | — | UNRESOLVED | — |
| Rehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Care as usual | Other | — | UNRESOLVED |
| Individualised rehabilitation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Control (high distress)
- description
- Control group receiving care as usual
- interventionNames
- Other: Care as usual
- type
- EXPERIMENTAL
- label
- Individualised rehabilitation
- description
- Patients with high distress receive the intervention "individualized rehabilitation" including evaluation of individual needs and based on that physical, psychological or social interventions to promote rehabilitation.
- interventionNames
- Other: Individualised rehabilitation
- type
- EXPERIMENTAL
- label
- Control group (low distress)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undergone treatment for primary breast cancer * ≤18 years old * Ability to communicate in Swedish * Written informed consent Exclusion Criteria: * Recurrent disease * Palliative diagnosis * Pregnancy * Prior history of breast cancer * Inability to participate in the study due to cognitive impairment
References
Publications (3)
- DERIVEDOlsson IM, Dykes C, Ryden L, Olsson-Moller U, Malmstrom M. Experiences of rehabilitation one year after breast cancer diagnosis-A focus group study from the ReScreen randomized controlled trial. PLoS One. 2025 Feb 13;20(2):e0315814. doi: 10.1371/journal.pone.0315814. eCollection 2025. PMID 39946344
- DERIVEDMalmstrom M, Holst-Hansson A, Olsson Moller U. The complexity of needs and roles of family members during breast cancer rehabilitation: a qualitative study. BMC Cancer. 2024 Nov 21;24(1):1430. doi: 10.1186/s12885-024-13200-x. PMID 39567939
- DERIVEDOlsson Moller U, Ryden L, Malmstrom M. Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial. BMC Cancer. 2020 May 29;20(1):484. doi: 10.1186/s12885-020-06815-3. PMID 32471390