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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 69
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Norway
Cancer Registry of Norway
RECRUITING
Oslo
Contact Information
Primary
Giske Ursin, MD, PhD
giske.ursin@kreftregisteret.no
+4722451300
Backup
Ine M Larsson
ine.marie.larsson@kreftregisteret.no
+4722928985
Time Frame
Start Date: 2021-01-15
Estimated Completion Date: 2035-12-31
Participants
Target number of participants: 390
Treatments
Active_comparator: Cognitive based stress management (CBSM)
Cognitive based digital intervention.
Active_comparator: Mindfulness based intervention (MBI)
Mindfulness based digital intervention.
Placebo_comparator: Control
Control arm. No intervention.
Related Therapeutic Areas
Sponsors
Leads: Norwegian Institute of Public Health

This content was sourced from clinicaltrials.gov