Supportive Cancer Care Networkers (SCAN)

Not Applicable

Completed

• Conditions: Chemotherapy; Colorectal Cancer
• Interventions: Behavioral: SCAN

• Registration Number: NCT01651832
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-27
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 261

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCAN-Intervention	SCAN	-

Primary Outcome Measures

Name	Time	Method
proportion of eligible patients undergoing adjuvant chemo therapy	8 weeks after hospital discharge/ chrirurgical resection

Secondary Outcome Measures

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

Trial Locations

Locations (9)

HELIOS Klinik Sangerhausen; 🇩🇪 Sangerhausen, Saxony-Anhalt, Germany

Carl-von-Basedow-Klinikum Merseburg; 🇩🇪 Merseburg, Saxony-Anhat, Germany

AMEOS Klinikum Schönebeck GmbH; 🇩🇪 Schönebeck, Saxony-Anhalt, Germany

AMEOS Klinikum Aschersleben-Staßfurt GmbH; 🇩🇪 Aschersleben, Saxony-Anhalt, Germany

Diakonissen-Krankhenhaus Leipzig; 🇩🇪 Leipzig, Saxony, Germany

Diakonissenkrankenhaus Dessau gGmbH; 🇩🇪 Dessau, Saxony-Anhalt, Germany

University Hospital Halle; 🇩🇪 Halle, Saxony-Anhalt, Germany

Klinikum Magdeburg gGmbH; 🇩🇪 Magdeburg, Saxony-Anhalt, Germany

HELIOS Klinik Lutherstadt Eisleben; 🇩🇪 Lutherstadt Eisleben, Saxony-Anhalt, Germany