RecruitingNot ApplicableNCT04480203

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

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


Sponsor

Norwegian Institute of Public Health

Enrollment

390 participants

Start Date

Jan 15, 2021

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 20 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study compares two digital support programs to help breast cancer patients cope emotionally after their diagnosis. One program focuses on self-management skills, the other uses online peer support. The goal is to find out which approach better reduces distress and improves wellbeing. **You may be eligible if...** - You were diagnosed with breast cancer (stage 0–III) for the first time from January 2020 onward - Your cancer has not spread to distant organs (not metastatic) - Your tumor is HER2-positive, or estrogen receptor-negative **You may NOT be eligible if...** - Your cancer has spread beyond the breast and nearby lymph nodes - You were diagnosed before January 2020 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStressproffen cognitive based stress management

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

OTHERStressproffen mindfulness based intervention

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

OTHERControl

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


Locations(1)

Cancer Registry of Norway

Oslo, Norway

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NCT04480203


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