Colorectal CancerSCANNCT01651832
Supportive Cancer Care Networkers (SCAN)
A study testing SCAN in people with Colorectal Cancer and Chemotherapy, run by Martin-Luther-Universität Halle-Wittenberg at 9 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Chemotherapy
- What is being tested?
- SCAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 9 sitesGermany
- Study dates
- Jul 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
AMEOS Klinikum Aschersleben-Staßfurt GmbH
Aschersleben, Saxony-Anhalt, 06449
Diakonissenkrankenhaus Dessau gGmbH
Dessau, Saxony-Anhalt, 06846
HELIOS Klinik Lutherstadt Eisleben
Eisleben Lutherstadt, Saxony-Anhalt, 06295
University Hospital Halle
Halle, Saxony-Anhalt, D-06112
Diakonissen-Krankhenhaus Leipzig
Leipzig, Saxony, 04177
Klinikum Magdeburg gGmbH
Magdeburg, Saxony-Anhalt, 39130
Carl-von-Basedow-Klinikum Merseburg
Merseburg, Saxony-Anhat, 06217
HELIOS Klinik Sangerhausen
Sangerhausen, Saxony-Anhalt, 06526
AMEOS Klinikum Schönebeck GmbH
Schönebeck, Saxony-Anhalt, 39218
About this study
Official title: Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
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.
Read the 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.
- Conditions
- Colorectal Cancer, Chemotherapy
- Being tested
- SCAN
- 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
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCANBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | routine care and case management |
| SCAN-Intervention | Experimental | Not described Receives: Behavioral: SCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of eligible patients undergoing adjuvant chemo therapy
Measured: 8 weeks after hospital discharge/ chrirurgical resection
Secondary outcomes (6)
disease-free survival
Measured: 8 month after hospital discharge/ chrirurgical resection
Health-related Quality of Life
using the EORTC QLQ-C30 \& CR-29
Measured: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
symptom burden
using the M.D. Anderson Symptom inventory
Measured: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
Distress
using the Distress-Thermometer
Measured: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
supportive care needs
using the Supportive Needs Questionnaire-37 (FU-T)
Measured: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
Quality of inpatient care
using the EORTC INPATSAT-32
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Bauer, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Margarete Landenberger, Prof. Dr., Study director, Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651832
- Sponsor's protocol ID
- 01GY1143
- Acronym
- SCAN
- Status last verified
- Oct 2016
- First submitted
- 25 Jul 2012
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26694748
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
- ClinicalTrials.gov ID
- NCT01651832
- Acronym / sponsor ID
- SCAN / 01GY1143
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –routine care and case management |
| SCAN-Intervention | Experimental | Behavioral: SCAN |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCANThe 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. | Behavioural | SCAN-Intervention |
Primary outcome
proportion of eligible patients undergoing adjuvant chemo therapy
Time frame: 8 weeks after hospital discharge/ chrirurgical resection
6 secondary outcomes
disease-free survival
Time frame: 8 month after hospital discharge/ chrirurgical resection
Health-related Quality of Life
Time frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
symptom burden
Time frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
Distress
Time frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
supportive care needs
Time frame: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
Quality of inpatient care
Time frame: at Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 26694748Bauer 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.
Related trials for Colorectal Cancer
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Recruiting
Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
Ampulla of Vater Carcinoma, Appendix Carcinoma
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
Rectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarete Landenberger, Prof. Dr. study director
Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCAN in people with Colorectal Cancer and Chemotherapy, run by Martin-Luther-Universität Halle-Wittenberg at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of eligible patients undergoing adjuvant chemo therapy (time frame: 8 weeks after hospital discharge/ chrirurgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.