Breast Cancer PatientsCABCNCT04480203
Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
A study testing Stressproffen cognitive based stress management and Stressproffen mindfulness based intervention in people with Breast Cancer Patients and Health, Subjective, run by Norwegian Institute of Public Health at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 69 years, women only
- Conditions the study is for
- Breast Cancer Patients, Health, Subjective
- What is being tested?
- Stressproffen cognitive based stress management and Stressproffen mindfulness based intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2021to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Cancer Registry of Norway
Oslo, 0379
Giske Ursin, +47 22928701, giske.ursin@kreftregisteret.no
Ine Marie Larsson, +4722928985, ine.marie.larsson@kreftregisteret.no
About this study
Official title: Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
- Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL.
- 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.
- 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.
Read the 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.
- Conditions
- Breast Cancer Patients, Health, Subjective
- Being tested
- Stressproffen cognitive based stress management, Stressproffen mindfulness based intervention, Control
- Keywords
- Health Related Quality of Life, Stress management intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stressproffen cognitive based stress managementOther
Also called CBSM
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
Stressproffen mindfulness based interventionOther
Also called MBI
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
ControlOther
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive based stress management (CBSM) | Active comparator | Cognitive based digital intervention. Receives: Other: Stressproffen cognitive based stress management |
| Mindfulness based intervention (MBI) | Active comparator | Mindfulness based digital intervention. Receives: Other: Stressproffen mindfulness based intervention |
| Control | Placebo comparator | Control arm. No intervention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Cohens perceived stress scale. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up week 21
Secondary outcomes (27)
Subjective health (HRQoL)
RAND-36 questionnaire. Unit is summary score and module-specific scores
Measured: change from CABC baseline (week 0) to f-up week 21
Coping
TOMCATS questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up week 21
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up week 21
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up week 21
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up week 21
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up week 21
EORTC QLQ-C30
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
Measured: From NBCR baseline to f-up week 20
EORTC QLQ-BR23
EORTC breast cancer questionnaire. Unit is summary score.
Measured: From NBCR baseline to f-up week 20
Neuropathy (FACT GOG-NTX and -ES)
neuropathy questionnaire. Unit is summary score.
Measured: From NBCR baseline to f-up week 20
Stress
Cohens perceived stress scale. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 15
Subjective health (HRQoL)
RAND-36 questionnaire. Unit is summary score and module-specific scores
Measured: change from CABC baseline (week 0) to f-up month 15
Coping
TOMCATS questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 15
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 15
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 15
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 15
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 15
Work
questions on employment. Whether employed and percentage
Measured: status at f-up month 15
Stress
Cohens perceived stress scale. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 27
Subjective health (HRQoL)
RAND-36 questionnaire. Unit is summary score and module-specific scores
Measured: change from CABC baseline (week 0) to f-up month 27
Coping
TOMCATS questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 27
Anxiety and depression
PHQ-4 questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 27
Fatigue
Chalders' fatigue questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 27
Mindfulness
Baer 2006 mindfulness questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 27
Sleep
selected questions fro SUSSH questionnaire. Unit is summary score.
Measured: change from CABC baseline (week 0) to f-up month 27
EORTC QLQ-C30
EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score.
Measured: change from NBCR baseline to f-up month 27
EORTC QLQ-BR23
EORTC breast cancer questionnaire. Unit is summary score.
Measured: change from NBCR baseline to f-up month 27
Neuropathy (FACT GOG-NTX and -ES)
neuropathy questionnaire. Unit is summary score.
Measured: From NBCR baseline to f-up month 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start15 Jan 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An intervention study of breast cancer patients with two digital intervention arms and one control group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Giske Ursin, MD, PhD, Principal investigator, Norwegian Institute of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480203
- Sponsor's protocol ID
- CABC - Kreftfor project - SEB
- Acronym
- CABC
- Status last verified
- Feb 2022
- First submitted
- 9 Jul 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41198868Svendsen 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.
PubMed 37103493
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
- ClinicalTrials.gov ID
- NCT04480203
- Acronym / sponsor ID
- CABC / CABC - Kreftfor project - SEB
- Conditions
- Breast Cancer Patients, Health, Subjective
- Keywords
- Health Related Quality of Life, Stress management intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- An intervention study of breast cancer patients with two digital intervention arms and one control group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive based stress management (CBSM) | Active comparator | Other: Stressproffen cognitive based stress managementCognitive based digital intervention. |
| Mindfulness based intervention (MBI) | Active comparator | Other: Stressproffen mindfulness based interventionMindfulness based digital intervention. |
| Control | Placebo comparator | Other: ControlControl arm. No intervention. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- first occurrence breast cancer diagnosed from Jan 1, 2020
- non-metastatic cancer stage 0-III
- HER2 positive (regardless of ER, PR) or
- ER negative
- (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stressproffen cognitive based stress managementAlso: CBSMThe participants will download an app (Stressproffen 2A) with cognitive based stress management. | Other | Cognitive based stress management (CBSM) |
| Stressproffen mindfulness based interventionAlso: MBIThe participants will download an app (Stressproffen 2B) with mindfulness based intervention. | Other | Mindfulness based intervention (MBI) |
| ControlThe participants will receive no app. (They will be able to download it after the end of the 3 year study). | Other | Control |
Primary outcome
Stress
Time frame: change from CABC baseline (week 0) to f-up week 21
Cohens perceived stress scale. Unit is summary score.
27 secondary outcomes
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
Fatigue
Time frame: change from CABC baseline (week 0) to f-up month 15
Mindfulness
Time frame: change from CABC baseline (week 0) to f-up month 15
Anxiety and depression
Time frame: change from CABC baseline (week 0) to f-up month 15
Sleep
Time frame: change from CABC baseline (week 0) to f-up month 15
Work
Time frame: status at f-up month 15
Stress
Time frame: change from CABC baseline (week 0) to f-up month 27
Subjective health (HRQoL)
Time frame: change from CABC baseline (week 0) to f-up month 27
Coping
Time frame: change from CABC baseline (week 0) to f-up month 27
Anxiety and depression
Time frame: change from CABC baseline (week 0) to f-up month 27
Fatigue
Time frame: change from CABC baseline (week 0) to f-up month 27
Mindfulness
Time frame: change from CABC baseline (week 0) to f-up month 27
Sleep
Time frame: change from CABC baseline (week 0) to f-up month 27
EORTC QLQ-C30
Time frame: change from NBCR baseline to f-up month 27
EORTC QLQ-BR23
Time frame: change from NBCR baseline to f-up month 27
Neuropathy (FACT GOG-NTX and -ES)
Time frame: From NBCR baseline to f-up month 27
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 41198868Svendsen 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.
- Derived from this study: PubMed 37103493Svendsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giske Ursin, MD, PhD principal investigator
Norwegian Institute of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stressproffen cognitive based stress management and Stressproffen mindfulness based intervention in people with Breast Cancer Patients and Health, Subjective, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giske Ursin, MD, PhD (+4722451300, giske.ursin@kreftregisteret.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: change from CABC baseline (week 0) to f-up week 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480203, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.