- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01651832
Supportive Cancer Care Networkers (SCAN) (SCAN)
Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04177
- Diakonissen-Krankhenhaus Leipzig
-
-
Saxony-Anhalt
-
Aschersleben, Saxony-Anhalt, Tyskland, 06449
- AMEOS Klinikum Aschersleben-Staßfurt GmbH
-
Dessau, Saxony-Anhalt, Tyskland, 06846
- Diakonissenkrankenhaus Dessau gGmbH
-
Halle, Saxony-Anhalt, Tyskland, D-06112
- University Hospital Halle
-
Lutherstadt Eisleben, Saxony-Anhalt, Tyskland, 06295
- HELIOS Klinik Lutherstadt Eisleben
-
Magdeburg, Saxony-Anhalt, Tyskland, 39130
- Klinikum Magdeburg gGmbH
-
Sangerhausen, Saxony-Anhalt, Tyskland, 06526
- HELIOS Klinik Sangerhausen
-
Schönebeck, Saxony-Anhalt, Tyskland, 39218
- AMEOS Klinikum Schönebeck GmbH
-
-
Saxony-Anhat
-
Merseburg, Saxony-Anhat, Tyskland, 06217
- Carl-von-Basedow-Klinikum Merseburg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: usual care
routine care and case management
|
|
Eksperimentel: SCAN-Intervention
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
proportion of eligible patients undergoing adjuvant chemo therapy
Tidsramme: 8 weeks after hospital discharge/ chrirurgical resection
|
8 weeks after hospital discharge/ chrirurgical resection
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
disease-free survival
Tidsramme: 8 month after hospital discharge/ chrirurgical resection
|
8 month after hospital discharge/ chrirurgical resection
|
|
Health-related Quality of Life
Tidsramme: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the EORTC QLQ-C30 & CR-29
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
symptom burden
Tidsramme: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the M.D. Anderson Symptom inventory
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
Distress
Tidsramme: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the Distress-Thermometer
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
supportive care needs
Tidsramme: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
using the Supportive Needs Questionnaire-37 (FU-T)
|
8 weeks & 8 month after hospital discharge/ chrirurgical resection
|
Quality of inpatient care
Tidsramme: at Baseline
|
using the EORTC INPATSAT-32
|
at Baseline
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Margarete Landenberger, Prof. Dr., Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Mennesker
- Livskvalitet
- Voksen
- Ældret
- Behandlingsresultat
- Sundhedstjenesters tilgængelighed
- Socioøkonomiske faktorer
- Alder, 80 og derover
- Kvalitetssikring, Sundhedspleje
- Psykoonkologi
- Landbefolkning
- Kolorektale neoplasmer/*lægemiddelbehandling/*sekundær
- Støttende plejebehov
- Primær sundhedspleje/*metoder
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 01GY1143
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kolorektal cancer
-
University of ArkansasAktiv, ikke rekrutterendeColorectal cancer og inflammatorisk tarmsygdomForenede Stater
-
University Health Network, TorontoAstraZenecaAktiv, ikke rekrutterendeAdenocarcinom i bugspytkirtlen | Leiomyosarkom | Mismatch Reparation Proficient Colorectal CancerCanada
-
Tianjin Medical University Cancer Institute and...RekrutteringMSI-H Advanced Colorectal CancerKina
-
Bristol-Myers SquibbAktiv, ikke rekrutterendeMikrosatellit stabil kolorektal cancer | Mismatch Reparation Proficient Colorectal Cancer | Mikrosatellit ustabil kolorektal cancer | Mismatch Reparation Manglende tyktarmskræftForenede Stater, Australien, Belgien, Canada, Irland, Italien, Spanien, Frankrig
-
Syndax PharmaceuticalsMerck Sharp & Dohme LLCAfsluttetMelanom | Ikke-småcellet lungekræft | Mismatch Reparation-Proficient Colorectal CancerForenede Stater
Kliniske forsøg med SCAN
-
Check-Cap Ltd.AfsluttetRisiko for tyktarmskræftIsrael
-
Medical University of ViennaAfsluttet
-
University Hospital AugsburgRekrutteringNeoplasmer | Neoplasma Metastase | Metastatisk kræftTyskland
-
University Hospital Plymouth NHS TrustAfsluttetKoronar stenoseDet Forenede Kongerige
-
Imperial College LondonAfsluttet
-
Check-Cap Ltd.Afsluttet
-
Central Hospital, Nancy, FranceAfsluttetMedicinsk behandlet aneurisme i abdominal aortaFrankrig
-
University Hospitals of North Midlands NHS TrustRekruttering
-
Guided TherapeuticsTilmelding efter invitationCervikal dysplasiForenede Stater
-
Sheffield Teaching Hospitals NHS Foundation TrustAfsluttetEndoskopiDet Forenede Kongerige