C50
Conditions
Interventions
Group 1: The intervention consists of three 50-minute sessions, i.e. one session per week, and is performed as an open group intervention. In the group intervention proven behavioral techniques are ap
Sponsors
VAMED Rehaklinik Ahrenshoop GmbH
Eligibility
Sex/Gender
Female
Age
29 Years to 79 Years
Inclusion criteria
Inclusion criteria: We include women with breast cancer (tumor stage I-IV) undergoing rehabilitation having a score of at least 5 points on the distress thermometer.
Exclusion criteria
Exclusion criteria: We exclude female patients already receiving psychiatric treatment or psychotherapy. We also exclude female patients with ductal carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the anxiety score measured by the Hospital Anxiety and Depressions Scale (HADS). The HADS is a questionnaire for the self-report of depression and anxiety which was developed for patients with physical illness (Zigmond and Snaith 1983). The anxiety module of the HADS consists of 7 items. Symptoms of anxiety during a period of one week are scored with 0 to 3 points. The total score ranges from 0 to 21 points. The level of anxiety is assessed at the beginning and the end of the rehabilitation program and 12 weeks after completing the program. The primary endpoint is the 12-week measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depressive symptoms: Depressive symptoms are also assessed with the HADS (Zigmond and Snaith 1983). The depression module consists of 7 items as well. The total score ranges from 0 to 21 points (assessment: at the beginning and the end of the rehabilitation program and 12 weeks after completing the program). Distress thermometer: Patients report their distress during the last week using 0 (patient is feeling very good) to 10 points (patient is feeling very bad). The distress thermometer was designed to evaluate psychosocial distress of cancer patients. It was developed by the American National Comprehensive Cancer Network, a collaborative partnership of 28 cancer centers in the United States. In Germany the distress thermometer is highly accepted (Mehnert et al. 2006) (assessment: at the beginning and the end of the rehabilitation program and 12 weeks after completing the program). Fatigue: Fatigue is measured by the Brief Fatigue Inventory which scores the severity (3 items) and the impact (6 items) of cancer-related fatigue (Mendoza et al. 1999). All items are scored with 0 to 10 points. Raw scores are averaged so that the fatigue total score also ranges from 0 to 10 points (assessment: at the beginning and the end of the rehabilitation program and 12 weeks after completing the program). Quality of life (EORTC QLQ-C30): Quality of life is assessed with the EORTC QLQ-C30 (Aaronson et al. 1993). The questionnaire provides scores for measuring physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and global health (2 items). Additional 13 items cover diverse symptoms and complaints such as pain and financial difficulties. The sub-scores are transformed into a range of values from 0 to 100 points. Higher scores indicate better health and quality of life more complaints in case of the symptom scores respectively (assessment: at the beginning and the end of the rehabi | — |
Countries
Germany
Contacts
Public ContactJohannes Mattes
VAMED Rehaklinik Ahrenshoop GmbH
Outcome results
None listed