[Trans-sectoral care for patients with colorectal cancer: Design of a prospective randomized controlled multi-center trial (FKZ 01GY1143)].

BACKGROUND: Health-related quality of life (HrQoL) is an increasingly focused aim in the care for patients with colorectal cancer that are treated with curative intent. Achieving this aim partly depends on the quality of the transsectoral management of these patients throughout the entire treatment course. However, recent population-based surveys have shown that HrQoL in patients with colorectal cancer is significantly impaired over a long time following initial diagnosis. This also applies to patients for whom adjuncant chemotherapy is not indicated according to the German medical S3 guideline. In addition, the patients' need for medical and psychosocial support has repeatedly been reported to persist at a significantly increased level - despite the extensive establishment of certified cancer centres which has apparently failed to solve this problem sufficiently. AIM: The SCAN intervention aims to increase the percentage of patients reaching an enhancement of their HrQoL by at least 12 points (range: 0-100 pts.) within eight weeks after hospital discharge by 15 percent compared to standard care. DESIGN AND METHODS: The SCAN intervention is carried out as a randomised controlled multicentre trial in seven large- and middle-sized hospitals all over Saxony-Anhalt. 370 patients have been enrolled, 185 of whom are offered additional nurse-led outpatient counselling. INTERVENTION: Patients in the intervention group are offered transitional guidance and support consisting of routine symptom assessment and patient counselling regarding self-management, informed therapy-related decision-making and psychosocial support. ENDPOINTS: The primary endpoint of the study is the patients' global health-related quality of life (HrQoL), assessed by the EORTC Quality of Life Questionnaire QLQ C-30 V3.0, item 30. Disease-free survival within eight months, the utilisation of indicated adjuvant chemotherapies as well as therapy-related side effects, e. g., anxiety and depression and the patients' symptom burden are monitored as secondary endpoints. EXPECTED
RESULTS: We assume that the SCAN intervention will be effective in increasing the percentage of patients reaching a clinically relevant enhancement of their HrQoL within eight weeks after hospital discharge by 15 percent compared to standard care.

RCT Entities:   Population Interventions Outcomes