Supportive Cancer Care Networkers (SCAN)

NCT ID: NCT01651832

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Colorectal Cancer; Chemotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

usual care

routine care and case management

Group Type: NO_INTERVENTION

No interventions assigned to this group

SCAN-Intervention

Group Type: EXPERIMENTAL

SCAN

Intervention Type: BEHAVIORAL

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.

Interventions

SCAN

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martin-Luther-Universität Halle-Wittenberg

OTHER

Sponsor Role: lead

Responsible Party

Alexander Bauer

Scientific Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margarete Landenberger, Prof. Dr.

Role: STUDY_DIRECTOR

Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science

Locations

Diakonissen-Krankhenhaus Leipzig

Leipzig, Saxony, Germany

AMEOS Klinikum Aschersleben-Staßfurt GmbH

Aschersleben, Saxony-Anhalt, Germany

Diakonissenkrankenhaus Dessau gGmbH

Dessau, Saxony-Anhalt, Germany

HELIOS Klinik Lutherstadt Eisleben

Eisleben Lutherstadt, Saxony-Anhalt, Germany

University Hospital Halle

Halle, Saxony-Anhalt, Germany

Klinikum Magdeburg gGmbH

Magdeburg, Saxony-Anhalt, Germany

HELIOS Klinik Sangerhausen

Sangerhausen, Saxony-Anhalt, Germany

AMEOS Klinikum Schönebeck GmbH

Schönebeck, Saxony-Anhalt, Germany

Carl-von-Basedow-Klinikum Merseburg

Merseburg, Saxony-Anhat, Germany

Countries

Germany

References

Bauer A, Vordermark D, Seufferlein T, Schmoll HJ, Dralle H, Mau W, Unverzagt S, Boese S, Fach EM, Landenberger M. Trans-sectoral care in patients with colorectal cancer: Protocol of the randomized controlled multi-center trial Supportive Cancer Care Networkers (SCAN). BMC Cancer. 2015 Dec 22;15:997. doi: 10.1186/s12885-015-2002-6.

Reference Type: DERIVED

PMID: 26694748 (View on PubMed)

Other Identifiers

01GY1143

Identifier Type: -

Identifier Source: org_study_id