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

Inclusion Criteria6

  • 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 Criteria1

  • None

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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