Supportive Cancer Care Networkers (SCAN) (SCAN)
Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Saxony
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Leipzig, Saxony, 독일, 04177
- Diakonissen-Krankhenhaus Leipzig
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Saxony-Anhalt
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Aschersleben, Saxony-Anhalt, 독일, 06449
- AMEOS Klinikum Aschersleben-Staßfurt GmbH
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Dessau, Saxony-Anhalt, 독일, 06846
- Diakonissenkrankenhaus Dessau gGmbH
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Halle, Saxony-Anhalt, 독일, D-06112
- University Hospital Halle
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Lutherstadt Eisleben, Saxony-Anhalt, 독일, 06295
- HELIOS Klinik Lutherstadt Eisleben
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Magdeburg, Saxony-Anhalt, 독일, 39130
- Klinikum Magdeburg gGmbH
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Sangerhausen, Saxony-Anhalt, 독일, 06526
- HELIOS Klinik Sangerhausen
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Schönebeck, Saxony-Anhalt, 독일, 39218
- AMEOS Klinikum Schönebeck GmbH
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Saxony-Anhat
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Merseburg, Saxony-Anhat, 독일, 06217
- Carl-von-Basedow-Klinikum Merseburg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: usual care
routine care and case management
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실험적: SCAN-Intervention
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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proportion of eligible patients undergoing adjuvant chemo therapy
기간: 8 weeks after hospital discharge/ chrirurgical resection
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8 weeks after hospital discharge/ chrirurgical resection
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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disease-free survival
기간: 8 month after hospital discharge/ chrirurgical resection
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8 month after hospital discharge/ chrirurgical resection
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Health-related Quality of Life
기간: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
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using the EORTC QLQ-C30 & CR-29
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8 weeks & 8 month after hospital discharge/ chrirurgical resection
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symptom burden
기간: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
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using the M.D. Anderson Symptom inventory
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8 weeks & 8 month after hospital discharge/ chrirurgical resection
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Distress
기간: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
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using the Distress-Thermometer
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8 weeks & 8 month after hospital discharge/ chrirurgical resection
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supportive care needs
기간: 8 weeks & 8 month after hospital discharge/ chrirurgical resection
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using the Supportive Needs Questionnaire-37 (FU-T)
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8 weeks & 8 month after hospital discharge/ chrirurgical resection
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Quality of inpatient care
기간: at Baseline
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using the EORTC INPATSAT-32
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at Baseline
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공동 작업자 및 조사자
수사관
- 연구 책임자: Margarete Landenberger, Prof. Dr., Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .