NCT01651832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

July 25, 2012

Last Update Submit

October 24, 2016

Conditions

Colorectal CancerChemotherapy

Keywords

Colorectal Neoplasms/*drug therapy/*secondaryHealth Services AccessibilityHumansSupportive Care NeedsPsychooncologyRural PopulationPrimary Health Care/*methodsTreatment OutcomeSocioeconomic FactorsQuality Assurance, Health CareQuality of LifeAdultAgedAged, 80 and over

Outcome Measures

Primary Outcomes (1)

  • proportion of eligible patients undergoing adjuvant chemo therapy

    8 weeks after hospital discharge/ chrirurgical resection

Secondary Outcomes (6)

  • disease-free survival

    8 month after hospital discharge/ chrirurgical resection

  • Health-related Quality of Life

    8 weeks & 8 month after hospital discharge/ chrirurgical resection

  • symptom burden

    8 weeks & 8 month after hospital discharge/ chrirurgical resection

  • Distress

    8 weeks & 8 month after hospital discharge/ chrirurgical resection

  • supportive care needs

    8 weeks & 8 month after hospital discharge/ chrirurgical resection

  • +1 more secondary outcomes

Study Arms (2)

usual care

NO INTERVENTION

routine care and case management

SCAN-Intervention

EXPERIMENTAL
Behavioral: SCAN

Interventions

SCANBEHAVIORAL

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.

SCAN-Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Diakonissen-Krankhenhaus Leipzig

Leipzig, Saxony, 04177, Germany

Location

AMEOS Klinikum Aschersleben-Staßfurt GmbH

Aschersleben, Saxony-Anhalt, 06449, Germany

Location

Diakonissenkrankenhaus Dessau gGmbH

Dessau, Saxony-Anhalt, 06846, Germany

Location

HELIOS Klinik Lutherstadt Eisleben

Eisleben Lutherstadt, Saxony-Anhalt, 06295, Germany

Location

University Hospital Halle

Halle, Saxony-Anhalt, D-06112, Germany

Location

Klinikum Magdeburg gGmbH

Magdeburg, Saxony-Anhalt, 39130, Germany

Location

HELIOS Klinik Sangerhausen

Sangerhausen, Saxony-Anhalt, 06526, Germany

Location

AMEOS Klinikum Schönebeck GmbH

Schönebeck, Saxony-Anhalt, 39218, Germany

Location

Carl-von-Basedow-Klinikum Merseburg

Merseburg, Saxony-Anhat, 06217, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26694748DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Margarete Landenberger, Prof. Dr.

    Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Research Fellow

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 27, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

DE(9)