Breast Cancer Patients, Health, Subjective
Conditions
Keywords
Health Related Quality of Life, Stress management intervention
Brief 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 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
OTHERStressproffen cognitive based stress management
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
OTHERStressproffen mindfulness based intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
OTHERControl
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
Sponsors
Norwegian Institute of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Only the staff that have contact with the participants will know who receives which intervention. The statistician and investigators will be masked.
Intervention model description
An intervention study of breast cancer patients with two digital intervention arms and one control group.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stress | change from CABC baseline (week 0) to f-up week 21 | Cohens perceived stress scale. Unit is summary score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coping | change from CABC baseline (week 0) to f-up week 21 | TOMCATS questionnaire. Unit is summary score. |
| Anxiety and depression | change from CABC baseline (week 0) to f-up week 21 | PHQ-4 questionnaire. Unit is summary score. |
| Fatigue | change from CABC baseline (week 0) to f-up week 21 | Chalders' fatigue questionnaire. Unit is summary score. |
| Mindfulness | change from CABC baseline (week 0) to f-up week 21 | Baer 2006 mindfulness questionnaire. Unit is summary score. |
| Sleep | change from CABC baseline (week 0) to f-up week 21 | selected questions fro SUSSH questionnaire. Unit is summary score. |
| Subjective health (HRQoL) | change from CABC baseline (week 0) to f-up week 21 | RAND-36 questionnaire. Unit is summary score and module-specific scores |
| EORTC QLQ-BR23 | From NBCR baseline to f-up week 20 | EORTC breast cancer questionnaire. Unit is summary score. |
| Neuropathy (FACT GOG-NTX and -ES) | From NBCR baseline to f-up week 20 | neuropathy questionnaire. Unit is summary score. |
| Stress | change from CABC baseline (week 0) to f-up month 15 | Cohens perceived stress scale. Unit is summary score. |
| Work | status at f-up month 15 | questions on employment. Whether employed and percentage |
| EORTC QLQ-C30 | From NBCR baseline to f-up week 20 | EORTC health related quality of life (HRQoL) general questionnaire. Unit is summary score. |
Countries
Norway
Contacts
Primary ContactGiske Ursin, MD, PhD
Backup ContactIne M Larsson
Outcome results
None listed