NCT04480203

Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions

Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Norwegian Institute of Public Health · Other Government
• Sex: Female
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Patients
• Health, Subjective

Interventions

Type	Name	Description
OTHER	Stressproffen cognitive based stress management	The participants will download an app (Stressproffen 2A) with cognitive based stress management.
OTHER	Stressproffen mindfulness based intervention	The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
OTHER	Control	The participants will receive no app. (They will be able to download it after the end of the 3 year study).

Timeline

• Start date: 2021-01-15
• Primary completion: 2023-08-31
• Completion: 2035-12-31
• First posted: 2020-07-21
• Last updated: 2022-03-02

Locations

1 site across 1 country: Norway