Supportive Cancer Care Networkers (SCAN) (SCAN)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Chemotherapy
• Intervention / Treatment: Behavioral: SCAN

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 Type: Interventional
• Enrollment (Actual): 261
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04177
      • Diakonissen-Krankhenhaus Leipzig
  • Saxony-Anhalt
    • Aschersleben, Saxony-Anhalt, Germany, 06449
      • AMEOS Klinikum Aschersleben-Staßfurt GmbH
    • Dessau, Saxony-Anhalt, Germany, 06846
      • Diakonissenkrankenhaus Dessau gGmbH
    • Halle, Saxony-Anhalt, Germany, D-06112
      • University Hospital Halle
    • Lutherstadt Eisleben, Saxony-Anhalt, Germany, 06295
      • HELIOS Klinik Lutherstadt Eisleben
    • Magdeburg, Saxony-Anhalt, Germany, 39130
      • Klinikum Magdeburg gGmbH
    • Sangerhausen, Saxony-Anhalt, Germany, 06526
      • HELIOS Klinik Sangerhausen
    • Schönebeck, Saxony-Anhalt, Germany, 39218
      • AMEOS Klinikum Schönebeck GmbH
  • Saxony-Anhat
    • Merseburg, Saxony-Anhat, Germany, 06217
      • Carl-von-Basedow-Klinikum Merseburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care; routine care and case management
Experimental: SCAN-Intervention	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Martin-Luther-Universität Halle-Wittenberg
• Investigators: Study Director: Margarete Landenberger, Prof. Dr., Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Humans; Quality of Life; Adult; Aged; Treatment Outcome; Health Services Accessibility; Socioeconomic Factors; Aged, 80 and over; Quality Assurance, Health Care; Psychooncology; Rural Population; Colorectal Neoplasms/*drug therapy/*secondary; Supportive Care Needs; Primary Health Care/*methods
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 01GY1143