C50.9 C50.2 C50.8 C50.0 C50.1 C50.3 C50.5 C50.6
Conditions
Interventions
Group 1: Participants will be randomly assigned to one of two study groups (intervention group or waitlist group). Intervention group: At the beginning and at the end of a 6- to 7-week treatment perio
Sponsors
Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Capacity to provide informed consent and ability to provide written informed consent independently - Diagnosis of non-metastatic breast cancer - Completion of primary treatment 6–24 months prior to study enrolment - Written informed consent
Exclusion criteria
Exclusion criteria: - Pregnancy or breastfeeding - Participation in another clinical trial - Language, cognitive, or psychological impairments that preclude informed consent or study participation - Lack of capacity to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cancer-related fatigue between baseline (T0) and the end of the 6- to 7-week treatment module (T1), assessed using the German version of the Cancer Fatigue Scale (CFS-D); compared between the intervention and control group | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in health-related quality of life (EORTC QLQ-C30), psychosocial distress (NCCN Distress Thermometer), internal coherence and resilience (Internal Coherence Scale, ICS) between baseline (T0) and the end of the 6- to 7-week treatment module (T1), as well as at the 3-month (T2) and 6-month (T3) follow-up assessments, assessed using the respective standardized questionnaires; compared between the intervention and control group | — |
Countries
Germany
Contacts
Public ContactFriedemann Schad
Forschungsinstitut Havelhöhe (FIH) gGmbH am Gemeinschaftskrankenhaus Havelhöhe
Outcome results
None listed