Supportive Cancer Care Networkers (SCAN)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial

Conditions
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Colorectal Cancer, Chemotherapy

Intervention / Treatment
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* Behavioral: SCAN


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>routine care and case management | |
| Experimental: SCAN-Intervention<br> | Behavioral: SCAN<br>* The Supportive Cancer Care Networkers intervention (SCAN) consists of an additional telephone support and symptom-related out-patient care management through Oncology Nursing. The SCAN intervention assesses patients' resources and barriers in utilizing health care services in order to meet their individual needs adequately and supports maintenance of therapy compliance. Thus, the SCAN offers a comprehensive mirroring the patients' medical and psychosocial care needs across changing sectors of health care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of eligible patients undergoing adjuvant chemo therapy |  | 8 weeks after hospital discharge/ chrirurgical resection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival |  | 8 month after hospital discharge/ chrirurgical resection | 
| Health-related Quality of Life | using the EORTC QLQ-C30 & CR-29 | 8 weeks & 8 month after hospital discharge/ chrirurgical resection | 
| symptom burden | using the M.D. Anderson Symptom inventory | 8 weeks & 8 month after hospital discharge/ chrirurgical resection | 
| Distress | using the Distress-Thermometer | 8 weeks & 8 month after hospital discharge/ chrirurgical resection | 
| supportive care needs | using the Supportive Needs Questionnaire-37 (FU-T) | 8 weeks & 8 month after hospital discharge/ chrirurgical resection | 
| Quality of inpatient care | using the EORTC INPATSAT-32 | at Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms/*drug therapy/*secondary, Health Services Accessibility, Humans, Supportive Care Needs, Psychooncology, Rural Population, Primary Health Care/*methods, Treatment Outcome, Socioeconomic Factors, Quality Assurance, Health Care, Quality of Life, Adult, Aged, Aged, 80 and over