Supportive Cancer Care Networkers (SCAN)

Colorectal Cancer Clinical Trial

— SCAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651832
• Other study ID #: 01GY1143
• Status: Completed
• Phase: N/A
• First received: July 25, 2012
• Last updated: October 24, 2016
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapy
• Colorectal Cancer
• Colorectal Neoplasms

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.

Locations

Country	Name	City	State
Germany	AMEOS Klinikum Aschersleben-Staßfurt GmbH	Aschersleben	Saxony-Anhalt
Germany	Diakonissenkrankenhaus Dessau gGmbH	Dessau	Saxony-Anhalt
Germany	University Hospital Halle	Halle	Saxony-Anhalt
Germany	Diakonissen-Krankhenhaus Leipzig	Leipzig	Saxony
Germany	HELIOS Klinik Lutherstadt Eisleben	Lutherstadt Eisleben	Saxony-Anhalt
Germany	Klinikum Magdeburg gGmbH	Magdeburg	Saxony-Anhalt
Germany	Carl-von-Basedow-Klinikum Merseburg	Merseburg	Saxony-Anhat
Germany	HELIOS Klinik Sangerhausen	Sangerhausen	Saxony-Anhalt
Germany	AMEOS Klinikum Schönebeck GmbH	Schönebeck	Saxony-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of eligible patients undergoing adjuvant chemo therapy		8 weeks after hospital discharge/ chrirurgical resection	No
Secondary	disease-free survival		8 month after hospital discharge/ chrirurgical resection	Yes
Secondary	Health-related Quality of Life	using the EORTC QLQ-C30 & CR-29	8 weeks & 8 month after hospital discharge/ chrirurgical resection	No
Secondary	symptom burden	using the M.D. Anderson Symptom inventory	8 weeks & 8 month after hospital discharge/ chrirurgical resection	No
Secondary	Distress	using the Distress-Thermometer	8 weeks & 8 month after hospital discharge/ chrirurgical resection	No
Secondary	supportive care needs	using the Supportive Needs Questionnaire-37 (FU-T)	8 weeks & 8 month after hospital discharge/ chrirurgical resection	No
Secondary	Quality of inpatient care	using the EORTC INPATSAT-32	at Baseline	No