Testing two digital stress-management interventions in a randomized controlled trial of breast cancer patients.
Karianne Svendsen, Lise Solberg Nes, Sigrid Leithe...
https://pubmed.ncbi.nlm.nih.gov/41198868Actively Recruiting
Phase Not Applicable
Age: 20Years - 69Years
FEMALE
ID04480203
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
Led by Norwegian Institute of Public Health · Updated on 2022-03-02
390
Participants Needed
1
Research Sites
643 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on breast cancer patients and age-matched controls to study stress management and quality of life after breast cancer. It aims to evaluate whether two digital interventions, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), can reduce stress levels and improve health-related quality of life (HRQoL) compared to a control group without intervention. Eligible breast cancer patients who complete a baseline quality of life assessment are invited to join a randomized clinical trial. Participants are assigned to one of three groups: digital cognitive based stress management via the Stressproffen app, digital mindfulness based intervention also via the Stressproffen app, or a control group that receives no app during the study but may access it after three years. During the study, participants' stress levels and quality of life are assessed from baseline through follow-ups at 21 weeks, 15 months, and 27 months. Researchers also measure coping ability, anxiety, depression, fatigue, mindfulness, sleep, and work status using questionnaires and validated tools. The trial includes double-blind randomization and tracks changes in these outcomes over time to understand the impact of the digital interventions.
CONDITIONS
Brief Title
Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Who Can Participate
Age: 20Years - 69Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female breast cancer patients with first occurrence diagnosed from January 1, 2020
- Breast cancer must be non-metastatic stage 0 to III
- Invasive tumors must be HER2 positive (any ER, PR status) or estrogen receptor negative
- Age between 20 and 69 years
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 21 weeks
Participants use one of two digital interventions: a cognitive based stress management app or a mindfulness based intervention app. Participants in the control group receive no app during the study period.
Baseline assessment and follow-up assessments during the 21 weeks
Follow-up
Duration - Up to 27 months
Participants are monitored for long-term effects and changes in stress, health-related quality of life, coping, anxiety, depression, fatigue, mindfulness, and sleep up to 27 months after baseline.
Periodic assessments during the follow-up period
Trial Site Locations
Total: 1 location
1
Cancer Registry of Norway
Oslo, Norway, 0379
Actively Recruiting
Loading map...
Research Team
G
Giske Ursin, MD, PhD
I
Ine M Larsson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions.
Karianne Svendsen, Lise Solberg Nes, Anders Meland...
https://pubmed.ncbi.nlm.nih.gov/37103493