Clinical trial NCT01651832: Supportive Cancer Care Networkers (SCAN)
Official title: Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: proportion of eligible patients undergoing adjuvant chemo therapy
timeFrame: 8 weeks after hospital discharge/ chrirurgical resection
Secondary outcomes:
measure: disease-free survival
timeFrame: 8 month after hospital discharge/ chrirurgical resection
measure: Health-related Quality of Life
timeFrame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
measure: symptom burden
timeFrame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
measure: Distress
timeFrame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
measure: supportive care needs
timeFrame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
measure: Quality of inpatient care
timeFrame: at Baseline
Other outcomes:
Locations:
city: Aschersleben
country: Germany
facility: AMEOS Klinikum Aschersleben-Staßfurt GmbH
state: Saxony-Anhalt
city: Dessau
country: Germany
facility: Diakonissenkrankenhaus Dessau gGmbH
state: Saxony-Anhalt
city: Halle
country: Germany
facility: University Hospital Halle
state: Saxony-Anhalt
city: Lutherstadt Eisleben
country: Germany
facility: HELIOS Klinik Lutherstadt Eisleben
state: Saxony-Anhalt
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gGmbH
state: Saxony-Anhalt
city: Sangerhausen
country: Germany
facility: HELIOS Klinik Sangerhausen
state: Saxony-Anhalt
city: Schönebeck
country: Germany
facility: AMEOS Klinikum Schönebeck GmbH
state: Saxony-Anhalt
city: Merseburg
country: Germany
facility: Carl-von-Basedow-Klinikum Merseburg
state: Saxony-Anhat
city: Leipzig
country: Germany
facility: Diakonissen-Krankhenhaus Leipzig
state: Saxony
Study officials:
affiliation: Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
name: Margarete Landenberger, Prof. Dr.
role: STUDY_DIRECTOR
References:
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.