Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Enrollment
- 261
- Locations
- 9
- Primary Endpoint
- proportion of eligible patients undergoing adjuvant chemo therapy
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
Aim of the study is to increase the proportion of indicated patients with colorectal cancer undergoing adjuvant chemotherapy following surgical resection through an optimized symptom management and logistical support.
Detailed Description
Patients with colorectal cancer in Germany today are exposed to several Problems related to care continuity and access to health care professionals. In order to increase the utilization of adjuvant therapies, patients in the intervention group are offered an additional nursing intervention in the period between discharge after inpatient treatment and the beginning of adjuvant therapy. This includes a telephone follow-up conducted according to guidelines serving to disclose patients' current supportive needs in order to determine potential intervention approaches as early as possible. Hence, the intervention aims to motivate patients not to discontinue the treatment. An early detection of therapy-related physical and psychological impairments aims at optimizing treatment management. Patients in the intervention group therefore are visited by nursing staff specialized in cancer care (Supportive Cancer Care Networkers, SCAN) during their in-patient stay and are informed about the intervention. An assignment for the SCAN is to support patients in getting access to health care services (e.g. specialists). Patients are given certain information, as for example contact to specialists, voluntary services and the next steps and appointments of the treatment plan are discussed. Within a consultation at the day before hospital discharge, the SCAN takes up the contact information and appoints weekly telephone consultations for the time up to the adjuvant therapy. The SCAN hands out information materials and explains the study documents, as for example patient-held records (PHR) in order to improve therapy compliance.
Investigators
Alexander Bauer
Scientific Research Fellow
Martin-Luther-Universität Halle-Wittenberg
Eligibility Criteria
Inclusion Criteria
- •colorectal carcinoma (ICD-10: C18, C19, C20)
- •indication for adjuvant chemo therapy following S3-Guideline on colorectal Cancer or physician-directed
- •living in Saxony-Anhalt
- •ECOG-Performance Status \<3
- •prospective further life expectancy of more than three months
Exclusion Criteria
- •unable to read or understand German properly
- •any contra-indication for adjuvant therapy as described in the S3-Guideline such as inadequate liver, bone marrow, and kidney function or coronary heart disease (NYHA III-IV).
Outcomes
Primary Outcomes
proportion of eligible patients undergoing adjuvant chemo therapy
Time Frame: 8 weeks after hospital discharge/ chrirurgical resection
Secondary Outcomes
- Distress(8 weeks & 8 month after hospital discharge/ chrirurgical resection)
- symptom burden(8 weeks & 8 month after hospital discharge/ chrirurgical resection)
- Quality of inpatient care(at Baseline)
- disease-free survival(8 month after hospital discharge/ chrirurgical resection)
- Health-related Quality of Life(8 weeks & 8 month after hospital discharge/ chrirurgical resection)
- supportive care needs(8 weeks & 8 month after hospital discharge/ chrirurgical resection)