C50 C61
Conditions
Interventions
Group 1: Immediate / intervention group (N=178)
With an average of 9 participants per training (minimum of 6 people, maximum 10 people) a total of 24 groups has to be carried out (i.e., per centre and
Sponsors
Klinik für Tumorbiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The study exclusively includes primary diseased patients with breast cancer or prostate cancer who have been treated respectively with curative intention. This selection is made in the light of the fact that for tumor patients in a palliative a different training content is required as for patients in a curative situation. Inclusion criteria breast cancer patients: - Curatively treated patients with a primary diagnosis of breast cancer (T1-4, to N3, M0) - Breast-conserving surgery or mastectomy - Adjuvant treatment (chemotherapy, radiotherapy) completed Inclusion criteria prostate cancer patients: - Curative treated patients with a primary diagnosis of prostate cancer (T1-4, to N1, M0) - Surgery (prostatectomy) or primary curative radiotherapy - Adjuvant radiotherapy completed
Exclusion criteria
Exclusion criteria: Excluded are patients whos cognitive limitations do not allow to participate in the study. Exclusion citeria breast cancer patients: secondary cancers, other malignancy within the last 10 years, linguistic or cognitive limitations, which make it difficult to participate the participation in the training program, severe psychiatric illness (psychosis, dementia, etc.), current psychotherapy. Exclusion criteria prostate cancer patient: patients without treatment under watchful waiting strategy, secondary cancers, other malignancy within the last 10 years, linguistic or cognitive limitations which make it difficult to participate in training program or impossible, severe psychiatric illness (psychosis, dementia, etc.), current psychotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| According to the intended effects of the training the primary outcome is the subscale 'ability to cope with emotional stress' of the self-assessment instrument for patient competency (FEPK-2-57) developed by Giesler & Weis (2008). The review of the achievement of objectives is based on the survey of the time points T1-T3: T1 after study inclusion and prior randomization, T2 after the end of training for immediate / intervention group or after an appropriate time of 6-8weeks for waiting / control group and T3 after 6-8 weeks for both groups. The completion of the data collection is planned at the beginning of the third year of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcome criteria other subscales of this instrument (FEPK-2-57) are used: intentional confrontation with the threat of cancer, self-confidence in dealing with clinicians / physicians and self-regulation. Moreover, the measuring of the fear of recurrence (PAF-KF), the experienced disease-related self-efficacy (CBI BD), the quality of life (EORTC QLQ-C30/Br23/PR25) and the psychological well-being and coping (PHQ-D) are intended. The review of the achievement of objectives is based on the survey of the time points T1-T3: T1 after study inclusion and prior randomization, T2 after the end of training for immediate / intervention group or after an appropriate time of 6-8weeks for waiting / control group and T3 after 6-8 weeks for both groups. The completion of the data collection is planned at the beginning of the third year of the study. | — |
Countries
Germany
Contacts
Public ContactKatrin Nagel
Klinik für Tumorbiologie an der Universität Freiburg
Outcome results
None listed