RecruitingNot Applicable

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

Norway390 participantsStarted 2021-01-15

Plain-language 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.

Who can participate

Age range20 Years – 69 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Stress

Timeframe: change from CABC baseline (week 0) to f-up week 21

Trial details

NCT IDNCT04480203

SponsorNorwegian Institute of Public Health

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-08-31

Contact for this trial

Giske Ursin, MD, PhD

+4722451300 giske.ursin@kreftregisteret.no

View on ClinicalTrials.gov More Breast Cancer Patients trials