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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive based stress management (CBSM) | Active Comparator | Cognitive based digital intervention. |
|
| Mindfulness based intervention (MBI) | Active Comparator | Mindfulness based digital intervention. |
|
| Control | Placebo Comparator | Control arm. No intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stressproffen cognitive based stress management | Other | The participants will download an app (Stressproffen 2A) with cognitive based stress management. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stress | Cohens perceived stress scale. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective health (HRQoL) | RAND-36 questionnaire. Unit is summary score and module-specific scores | change from CABC baseline (week 0) to f-up week 21 |
| Coping | TOMCATS questionnaire. Unit is summary score. |
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Inclusion Criteria:
Invasive tumors must be:
Exclusion Criteria:
Female breast cancer patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giske Ursin, MD, PhD | Contact | +4722451300 | giske.ursin@kreftregisteret.no | |
| Ine M Larsson | Contact | +4722928985 | ine.marie.larsson@kreftregisteret.no |
| Name | Affiliation | Role |
|---|---|---|
| Giske Ursin, MD, PhD | Norwegian Institute of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Registry of Norway | Recruiting | Oslo | 0379 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41198868 | Derived | 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. | |
| 37103493 |
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An intervention study of breast cancer patients with two digital intervention arms and one control group.
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Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.
|
| Stressproffen mindfulness based intervention | Other | The participants will download an app (Stressproffen 2B) with mindfulness based intervention. |
|
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| Control | Other | The participants will receive no app. (They will be able to download it after the end of the 3 year study). |
|
| change from CABC baseline (week 0) to f-up week 21 |
| Anxiety and depression | PHQ-4 questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 |
| Fatigue | Chalders' fatigue questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 |
| Mindfulness | Baer 2006 mindfulness questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up week 21 |
| Sleep | selected questions fro SUSSH questionnaire. Unit is summary score. | 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. | From NBCR baseline to f-up week 20 |
| EORTC QLQ-BR23 | EORTC breast cancer questionnaire. Unit is summary score. | From NBCR baseline to f-up week 20 |
| Neuropathy (FACT GOG-NTX and -ES) | neuropathy questionnaire. Unit is summary score. | From NBCR baseline to f-up week 20 |
| Stress | Cohens perceived stress scale. Unit is summary score. | 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 | change from CABC baseline (week 0) to f-up month 15 |
| Coping | TOMCATS questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 |
| Fatigue | Chalders' fatigue questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 |
| Mindfulness | Baer 2006 mindfulness questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 |
| Anxiety and depression | PHQ-4 questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 |
| Sleep | selected questions fro SUSSH questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 15 |
| Work | questions on employment. Whether employed and percentage | status at f-up month 15 |
| Stress | Cohens perceived stress scale. Unit is summary score. | 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 | change from CABC baseline (week 0) to f-up month 27 |
| Coping | TOMCATS questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 |
| Anxiety and depression | PHQ-4 questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 |
| Fatigue | Chalders' fatigue questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 |
| Mindfulness | Baer 2006 mindfulness questionnaire. Unit is summary score. | change from CABC baseline (week 0) to f-up month 27 |
| Sleep | selected questions fro SUSSH questionnaire. Unit is summary score. | 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. | change from NBCR baseline to f-up month 27 |
| EORTC QLQ-BR23 | EORTC breast cancer questionnaire. Unit is summary score. | change from NBCR baseline to f-up month 27 |
| Neuropathy (FACT GOG-NTX and -ES) | neuropathy questionnaire. Unit is summary score. | From NBCR baseline to f-up month 27 |
| 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. |