Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stressproffen cognitive based stress management, Stressproffen mindfulness based intervention, Control.
- Who it may be relevant to
- Registry conditions: Breast Cancer Patients, Health, Subjective. Basic parameters: 20 years — 69 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
Overview
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.
Detailed description
After completing the baseline HRQoL assessment, eligible breast cancer patients will be invited to participate in a randomized clinical trial.
Those who are willing will be randomly allocated to one of the following arms: a) Digital cognitive based stress management, b) Digital mindfulness based intervention or c) Control group.
The intervention is based on a revised version of the Stressproffen app, which was developed by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).
Outcome measures include measures of perceived stress and HRQoL.
Interventions
- Other Stressproffen cognitive based stress management
The participants will download an app (Stressproffen 2A) with cognitive based stress management. - Other Stressproffen mindfulness based intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention. - Other Control
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
Primary outcome measures
- Stress [Time frame: change from CABC baseline (week 0) to f-up week 21]
Secondary outcome measures (12)
- Subjective health (HRQoL) [Time frame: change from CABC baseline (week 0) to f-up week 21]
- Coping [Time frame: change from CABC baseline (week 0) to f-up week 21]
- Anxiety and depression [Time frame: change from CABC baseline (week 0) to f-up week 21]
- Fatigue [Time frame: change from CABC baseline (week 0) to f-up week 21]
- Mindfulness [Time frame: change from CABC baseline (week 0) to f-up week 21]
- Sleep [Time frame: change from CABC baseline (week 0) to f-up week 21]
- EORTC QLQ-C30 [Time frame: From NBCR baseline to f-up week 20]
- EORTC QLQ-BR23 [Time frame: From NBCR baseline to f-up week 20]
- Neuropathy (FACT GOG-NTX and -ES) [Time frame: From NBCR baseline to f-up week 20]
- Stress [Time frame: change from CABC baseline (week 0) to f-up month 15]
- Subjective health (HRQoL) [Time frame: change from CABC baseline (week 0) to f-up month 15]
- Coping [Time frame: change from CABC baseline (week 0) to f-up month 15]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Norway · 1 center
- Cancer Registry of Norway — Oslo
Publications
- Svendsen 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
- Svendsen 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
Identifiers
NCT: NCT04480203 · CABC - Kreftfor project - SEB