C18 C19 C20
Conditions
Interventions
Group 1: At the begin of rehabilitation (baseline):
- self-administered questionnaires (see primary and secondary endpoints for further details)
- measurement of height, weight and waist circumferenc
Sponsors
Deutsches Krebsforschungszentrum (DKFZ)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Colorectal cancer diagnosis (ICD-10 C18-20 and C21.8) - CRC therapy in last 12 months (surgical removal of tumor, radiation and/or chemotherapy (adjuvant or neoadjuvant)) - At least 3 weeks of in-patient rehabilitation in a cooperating clinic are planned - Sufficient knowledge of the German language and mental capability to be able to give written informed consent and comply with the study requirements
Exclusion criteria
Exclusion criteria: - Subjects who do not consent to participate or who are incapable of giving their own consent will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Cancer-related fatigue assessed by using validated questionnaires (FACIT-F and EORTC-QLQ-FA12) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall and domain-specific quality of life assessed by using a validated questionnaire tool (EORTC-QLC C30) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years - Colorectal cancer-specific quality of life assessed by using a validated questionnaire tool (EORTC-QLQ CR29) in month 10 - Distress in cancer assessed by using a validated questionnaire tool (QSC-R10) in month 10 - Functional well-being assessed by using a validated questionnaire tool (FACIT-F-FWB) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years - Infection frequencies (total, upper respiratory and lower respiratory tract infections) assessed by self-report of study participants in month 4 and after 1, 3, 5, 7, 10 years - Return to work assessed by self-report of study participants and by using the count of paid working hours in month 4, 7, 10 and after 1, 3, 5, 7, 10 years - Disease-related early retirement assessed by self-report of study participants after 1 year - Subjective ability to work assessed by the short version of the Work Ability Index (WAI) in month 10 - Frailty assessed by using a validated questionnaire tool (FRAIL-Scale) after 1, 3, 5, 7, 10 years - Falls, fractures including (non-)vertebral and hip fractures assessed by self-report of study participants after 1, 3, 5, 7, 10 years - Depressive symptoms assessed by using a validated questionnaire tool (GDS-15) in month 4, 7, 10 and after 1, 3, 5, 7, 10 years - Depressive episodes assessed by self-report of study participants after 1, 3, 5, 7 and 10 years - Anxiety assessed by using a validated questionnaire tool (GAD-7) after 1 year - Cancer incidence assessed by self-report of study participants after 1, 3, 5, 7 and 10 years - Cancer mortality (ICD-10 code C00-C97, D00-D09 or D37-48 as leading cause of death) assessed by register matching after 1, 3, 5, 7 and 10 years - Colorectal-cancer mortality (ICD-10 code C18-C21 as leading cause of death) assessed by register matching after 1, 3, 5, 7 and 10 years - Cardiovascu | — |
Countries
Germany
Outcome results
None listed