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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT03968250
Eligibility Criteria:
Inclusion Criteria:
* fluency in German language
* able to access the internet and use and follow a web-based Cognitive Behavioral intervention
* in complete remission after treatment for newly diagnosed HL without signs of relapse (no previous relapse)
* clinically relevant fatigue symptoms enduring at least 12 months after end of treatment (QLQ-C30 FA-12 ≥ 30 over at least two time points within the previous assessments in the course of the GHSG-trials)
* fatigue being related to HL and its treatment and interferes with usual functioning, i.e. fulfills the definition of CRF \[1, 16\].
Exclusion Criteria:
* Major communication difficulties
* severe cognitive impairment that would interfere with a patient's ability to give informed consent for research (indicated by the medical care team)
* Karnofsky Performance Status scale score \< 70 predicting an expected survival of less than 6 months
* somatic co-morbidities that could explain the presence of severe fatigue (e.g. Chronic Obstructive Pulmonary Disease or heart failure) according to the hemato-oncologists examining the potential participant before inclusion for the study
* history of relapsed or refractory HL
* clinical symptoms which may indicate a relapse of HL
* current depressive disorder and related psychotropic or psychological treatment
* Currently receiving medical and/or psychological treatment for a psychiatric disorder, other than the use of an anti-depressant
* current treatment aimed at fatigue
* previous attempt to treat fatigue with behavioral psychological therapy
* pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03968250
Study Brief:
Protocol Section:
NCT03968250