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

RECRUITINGN/ASponsored by Norwegian Institute of Public Health
Actively Recruiting
PhaseN/A
SponsorNorwegian Institute of Public Health
Started2021-01-15
Est. completion2023-08-31
Eligibility
Age20 Years – 69 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04480203

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

Age: 20 Years – 69 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions4

Breast CancerBreast Cancer PatientsCancerHealth, Subjective

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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