Clinical trial · Interventional
Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
- 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)
1. Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL. 2. Among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), as well as a control group. 3. The goal is to determine whether digital CBSM or MBI can effectively reduce stress levels as compared to a control group. Second, whether these interventions can improve HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a control group.
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 Patients | — | UNRESOLVED | — |
| Health, Subjective | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Stressproffen cognitive based stress management | Other | — | UNRESOLVED |
| Stressproffen mindfulness based intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Cognitive based stress management (CBSM)
- description
- Cognitive based digital intervention.
- interventionNames
- Other: Stressproffen cognitive based stress management
- type
- ACTIVE_COMPARATOR
- label
- Mindfulness based intervention (MBI)
- description
- Mindfulness based digital intervention.
- interventionNames
- Other: Stressproffen mindfulness based intervention
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- Control arm. No intervention.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * first occurrence breast cancer diagnosed from Jan 1, 2020 * non-metastatic cancer stage 0-III Invasive tumors must be: * HER2 positive (regardless of ER, PR) or * ER negative * (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA) Exclusion Criteria: * None
References
Publications (2)
- DERIVEDSvendsen K, Nes LS, Leithe S, Meland A, Gjelsvik YM, Borosund E, Larsson IM, Myklebust TA, Balto A, Rygg CM, Kiserud CE, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Testing two digital stress-management interventions in a randomized controlled trial of breast cancer patients. Sci Rep. 2025 Nov 6;15(1):38966. doi: 10.1038/s41598-025-22889-0. PMID 41198868
- DERIVEDSvendsen K, Nes LS, Meland A, Larsson IM, Gjelsvik YM, Borosund E, Rygg CM, Myklebust TA, Reinertsen KV, Kiserud CE, Skjerven H, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions. JMIR Res Protoc. 2023 May 24;12:e47195. doi: 10.2196/47195. PMID 37103493