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Supportive Cancer Care Networkers (SCAN) (SCAN)

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ClinicalTrials.gov Identifier: NCT01651832
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Chemotherapy Behavioral: SCAN Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
Study Start Date : July 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. proportion of eligible patients undergoing adjuvant chemo therapy [ Time Frame: 8 weeks after hospital discharge/ chrirurgical resection ]

Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: 8 month after hospital discharge/ chrirurgical resection ]
  2. Health-related Quality of Life [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ]
    using the EORTC QLQ-C30 & CR-29

  3. symptom burden [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ]
    using the M.D. Anderson Symptom inventory

  4. Distress [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ]
    using the Distress-Thermometer

  5. supportive care needs [ Time Frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection ]
    using the Supportive Needs Questionnaire-37 (FU-T)

  6. Quality of inpatient care [ Time Frame: at Baseline ]
    using the EORTC INPATSAT-32


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  • 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651832


Locations
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Germany
AMEOS Klinikum Aschersleben-Staßfurt GmbH
Aschersleben, Saxony-Anhalt, Germany, 06449
Diakonissenkrankenhaus Dessau gGmbH
Dessau, Saxony-Anhalt, Germany, 06846
University Hospital Halle
Halle, Saxony-Anhalt, Germany, D-06112
HELIOS Klinik Lutherstadt Eisleben
Lutherstadt Eisleben, Saxony-Anhalt, Germany, 06295
Klinikum Magdeburg gGmbH
Magdeburg, Saxony-Anhalt, Germany, 39130
HELIOS Klinik Sangerhausen
Sangerhausen, Saxony-Anhalt, Germany, 06526
AMEOS Klinikum Schönebeck GmbH
Schönebeck, Saxony-Anhalt, Germany, 39218
Carl-von-Basedow-Klinikum Merseburg
Merseburg, Saxony-Anhat, Germany, 06217
Diakonissen-Krankhenhaus Leipzig
Leipzig, Saxony, Germany, 04177
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
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Study Director: Margarete Landenberger, Prof. Dr. Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alexander Bauer, Scientific Research Fellow, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01651832    
Other Study ID Numbers: 01GY1143
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Alexander Bauer, 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:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases