Status:
TERMINATED
Evaluating a Novel Web-based Intervention for Breast Cancer Survivors
Lead Sponsor:
Technical University of Dortmund
Collaborating Sponsors:
University of Leipzig
Gaia AG
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-70 years
Phase:
NA
Brief Summary
The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to women with breast c...
Detailed Description
Depression and fatigue is common in breast cancer survivors and its presence is associated with personal suffering, increased inflammatory activity, and worse prognosis. While in the phase of acute tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03448250
Start Date
March 16 2018
End Date
April 30 2022
Last Update
May 5 2022
Active Locations (2)
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1
Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors
Dortmund, Germany, 44139
2
University Medical Center Leipzig, Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology
Leipzig, Germany, 04103