Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT03448250
Eligibility Criteria:
Inclusion Criteria:
Eligible are women who
* had breast cancer diagnosed less than 4 years ago, classified as T0-4, N0-1, M0
* completed acute treatment for breast cancer at least 6 month ago. This applies for surgery, chemotherapy or radiation, whichever occurred last. (Prophylactic treatment with anti-hormones like tamoxifen, aromatase-inhibitors or bisphosphonates is allowed).
* are competent in German language
* provide written consent to study procedures
* are willing to provide the discharge letter from oncology (to verify diagnosis and therapies)
Exclusion Criteria:
Women are not eligible if they
* have a prior history of breast cancer (other than the current one) or any other cancer except basal or squamous cell skin cancer
* suffer from the following autoimmune and/or inflammatory diseases: rheumatoid arthritis, lupus erythematodes, psoriasis, multiple sclerosis or inflammatory breast cancer
* have a history of schizophrenia, bipolar disorder, or an established diagnosis of borderline personality disorder
* have elevated current suicide risk
* routinely attend psychotherapy, either 1:1, group-therapy or web-based interaction (at least two sessions per month)
* practice 5 hours or more of vigorous physical activity per week (e.g. training for marathon)
* have cognitive impairment
* abuse alcohol or drugs
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT03448250
Study Brief:
Protocol Section:
NCT03448250