Supportive Cancer Care Networkers (SCAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Martin-Luther-Universität Halle-Wittenberg
Sponsor:
Information provided by (Responsible Party):
Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01651832
First received: July 25, 2012
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Chemotherapy
Behavioral: SCAN

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Supportive Cancer Care Netwokers - a Prospective Randomized Controlled Multi-center Trial

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • proportion of eligible patients undergoing adjuvant chemo therapy [ Time Frame: 8 weeks after hospital discharge/ chrirurgical resection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease-free survival [ Time Frame: 8 month after hospital discharge/ chrirurgical resection ] [ Designated as safety issue: Yes ]
  • Health-related Quality of Life [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ] [ Designated as safety issue: No ]
    using the EORTC QLQ-C30 & CR-29

  • symptom burden [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ] [ Designated as safety issue: No ]
    using the M.D. Anderson Symptom inventory

  • Distress [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ] [ Designated as safety issue: No ]
    using the Distress-Thermometer

  • supportive care needs [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ] [ Designated as safety issue: No ]
    using the Supportive Needs Quastionaire-37 (FU-T)

  • Quality of inpatient care [ Time Frame: at Baseline ] [ Designated as safety issue: No ]
    using the EORTC INPATSAT-32


Estimated Enrollment: 700
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • unabled to read oder 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651832

Contacts
Contact: Alexander Bauer, Dr. +49 345 557-4124 alexander.bauer@medizin.uni-halle.de
Contact: Margarete Landenberger, Prof. Dr. phil. habil. +49 345 557-1220 margarete.landenberger@medizin.uni-halle.de

Locations
Germany
AMEOS Klinikum Aschersleben-Staßfurt GmbH Recruiting
Aschersleben, Saxony-Anhalt, Germany, 06449
Contact: Jan Wieland, Dr.    +49(0) 3473-971279    j.wieland@kkl.de   
Principal Investigator: Jan Wieland, Dr.         
Diakonissenkrankenhaus Dessau gGmbH Recruiting
Dessau, Saxony-Anhalt, Germany, 06846
Contact: Jens P. May, Dr.    +49(0) 340-6502-2110    chirurgie@dkd-dessau.de   
Principal Investigator: Jens P May, Dr.         
University Hospital Halle Recruiting
Halle, Saxony-Anhalt, Germany, D-06112
Contact: Jörn Rüssel, Dr.    +49 345 557-7223    joern.ruessel@uk-halle.de   
Sub-Investigator: Jörn Rüssel, Dr.         
HELIOS Klinik Lutherstadt Eisleben Not yet recruiting
Lutherstadt Eisleben, Saxony-Anhalt, Germany, 06295
Contact: Stefan Kothe, Dr.    03475-901040    stefan.kothe@helios-kliniken.de   
Sub-Investigator: Stefan Kothe, Dr.         
Klinikum Magdeburg gGmbH Recruiting
Magdeburg, Saxony-Anhalt, Germany, 39130
Contact: Karsten Ridwelski, Prof. Dr.    +49(0) 391-7914200    karsten.ridwelski@klinikum-magdeburg.de   
Principal Investigator: Karsten Ridwelski, Prof. Dr.         
HELIOS Klinik Sangerhausen Recruiting
Sangerhausen, Saxony-Anhalt, Germany, 06526
Contact: Bernd Klinge, Dr.    +49(0) 3464-663500    bernd.klinge@helios-kliniken.de   
Principal Investigator: Bernd Klinge, Dr.         
AMEOS Klinikum Schönebeck GmbH Recruiting
Schönebeck, Saxony-Anhalt, Germany, 39218
Contact: Andreas Thews, Dr.    +49 (0) 3928-641101    darmzentrum@kh-sbk.de   
Principal Investigator: Andreas Thews, Dr.         
Carl-von-Basedow-Klinikum Merseburg Recruiting
Merseburg, Saxony-Anhat, Germany, 06217
Contact: Sven Hake, Dr.    +49(0) 3461-274500    s.hake@klinikum-saalekreis.de   
Principal Investigator: Sven Hake, Dr.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Alexander Bauer, Scientific Research Fellow, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01651832     History of Changes
Other Study ID Numbers: 01GY1143
Study First Received: July 25, 2012
Last Updated: April 18, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on August 28, 2014