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Completed

NCT Number: NCT01651832

Supportive Cancer Care Networkers (SCAN)

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonissen-Krankhenhaus Leipzig, Leipzig, Saxony, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SCAN

Behavioral

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 outcomes

  1. proportion of eligible patients undergoing adjuvant chemo therapy

    Time frame: 8 weeks after hospital discharge/ chrirurgical resection

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

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

Acronym: SCAN

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 27, 2012
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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