Supportive Cancer Care Networkers (SCAN) (SCAN)
Primary Purpose
Colorectal Cancer, Chemotherapy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
SCAN
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring 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
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).
Sites / Locations
- AMEOS Klinikum Aschersleben-Staßfurt GmbH
- Diakonissenkrankenhaus Dessau gGmbH
- University Hospital Halle
- HELIOS Klinik Lutherstadt Eisleben
- Klinikum Magdeburg gGmbH
- HELIOS Klinik Sangerhausen
- AMEOS Klinikum Schönebeck GmbH
- Carl-von-Basedow-Klinikum Merseburg
- Diakonissen-Krankhenhaus Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
usual care
SCAN-Intervention
Arm Description
routine care and case management
Outcomes
Primary Outcome Measures
proportion of eligible patients undergoing adjuvant chemo therapy
Secondary Outcome Measures
disease-free survival
Health-related Quality of Life
using the EORTC QLQ-C30 & CR-29
symptom burden
using the M.D. Anderson Symptom inventory
Distress
using the Distress-Thermometer
supportive care needs
using the Supportive Needs Questionnaire-37 (FU-T)
Quality of inpatient care
using the EORTC INPATSAT-32
Full Information
NCT ID
NCT01651832
First Posted
July 25, 2012
Last Updated
October 24, 2016
Sponsor
Martin-Luther-Universität Halle-Wittenberg
1. Study Identification
Unique Protocol Identification Number
NCT01651832
Brief Title
Supportive Cancer Care Networkers (SCAN)
Acronym
SCAN
Official Title
Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Chemotherapy
Keywords
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
No Intervention
Arm Description
routine care and case management
Arm Title
SCAN-Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
SCAN
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of eligible patients undergoing adjuvant chemo therapy
Time Frame
8 weeks after hospital discharge/ chrirurgical resection
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
8 month after hospital discharge/ chrirurgical resection
Title
Health-related Quality of Life
Description
using the EORTC QLQ-C30 & CR-29
Time Frame
8 weeks & 8 month after hospital discharge/ chrirurgical resection
Title
symptom burden
Description
using the M.D. Anderson Symptom inventory
Time Frame
8 weeks & 8 month after hospital discharge/ chrirurgical resection
Title
Distress
Description
using the Distress-Thermometer
Time Frame
8 weeks & 8 month after hospital discharge/ chrirurgical resection
Title
supportive care needs
Description
using the Supportive Needs Questionnaire-37 (FU-T)
Time Frame
8 weeks & 8 month after hospital discharge/ chrirurgical resection
Title
Quality of inpatient care
Description
using the EORTC INPATSAT-32
Time Frame
at Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarete Landenberger, Prof. Dr.
Organizational Affiliation
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
Official's Role
Study Director
Facility Information:
Facility Name
AMEOS Klinikum Aschersleben-Staßfurt GmbH
City
Aschersleben
State/Province
Saxony-Anhalt
ZIP/Postal Code
06449
Country
Germany
Facility Name
Diakonissenkrankenhaus Dessau gGmbH
City
Dessau
State/Province
Saxony-Anhalt
ZIP/Postal Code
06846
Country
Germany
Facility Name
University Hospital Halle
City
Halle
State/Province
Saxony-Anhalt
ZIP/Postal Code
D-06112
Country
Germany
Facility Name
HELIOS Klinik Lutherstadt Eisleben
City
Lutherstadt Eisleben
State/Province
Saxony-Anhalt
ZIP/Postal Code
06295
Country
Germany
Facility Name
Klinikum Magdeburg gGmbH
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
39130
Country
Germany
Facility Name
HELIOS Klinik Sangerhausen
City
Sangerhausen
State/Province
Saxony-Anhalt
ZIP/Postal Code
06526
Country
Germany
Facility Name
AMEOS Klinikum Schönebeck GmbH
City
Schönebeck
State/Province
Saxony-Anhalt
ZIP/Postal Code
39218
Country
Germany
Facility Name
Carl-von-Basedow-Klinikum Merseburg
City
Merseburg
State/Province
Saxony-Anhat
ZIP/Postal Code
06217
Country
Germany
Facility Name
Diakonissen-Krankhenhaus Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04177
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26694748
Citation
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.
Results Reference
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