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Clinical 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 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04480203
Study type Interventional
Source Cancer Registry of Norway
Contact Giske Ursin, MD, PhD
Phone +4722451300
Email giske.ursin@kreftregisteret.no
Status Recruiting
Phase N/A
Start date January 15, 2021
Completion date December 31, 2035

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