Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Recruiting · NCT04480203 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
ControlStressproffen cognitive based stress managementStressproffen mindfulness based intervention
What this trial is about
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.
Who can take part
Age range
20 Years to 69 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Cancer Registry of Norway - Oslo, Norway