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Clinical Trials in Norway / NCT04480203
Recruiting Not applicable

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

NCT04480203 · tracked via the Priya Life Science Norway tracker
Sponsor
Norwegian Institute of Public Health
Phase
Not applicable
Started
2021-01-15
Last updated
2022-03-02

Condition(s) studied

Breast Cancer PatientsHealth, Subjective

Investigational drug(s) / intervention(s)

Stressproffen cognitive based stress managementStressproffen mindfulness based interventionControl

Stressproffen cognitive based stress management: The participants will download an app (Stressproffen 2A) with cognitive based stress management.

Stressproffen mindfulness based intervention: The participants will download an app (Stressproffen 2B) with mindfulness based intervention.

Control: The participants will receive no app. (They will be able to download it after the end of the 3 year study).

Study 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

Sex
FEMALE
Min age
20 Years
Max age
69 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Registry of Norway Oslo Norway Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04480203 on ClinicalTrials.gov ↗ ← All trials in Norway