Supportive Cancer Care Networkers (SCAN) (SCAN)
Supportive Cancer Care Networkers - a Prospective Randomized Controlled Multi-center Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Saxony
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Leipzig、Saxony、ドイツ、04177
- Diakonissen-Krankhenhaus Leipzig
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Saxony-Anhalt
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Aschersleben、Saxony-Anhalt、ドイツ、06449
- AMEOS Klinikum Aschersleben-Staßfurt GmbH
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Dessau、Saxony-Anhalt、ドイツ、06846
- Diakonissenkrankenhaus Dessau gGmbH
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Halle、Saxony-Anhalt、ドイツ、D-06112
- University Hospital Halle
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Lutherstadt Eisleben、Saxony-Anhalt、ドイツ、06295
- HELIOS Klinik Lutherstadt Eisleben
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Magdeburg、Saxony-Anhalt、ドイツ、39130
- Klinikum Magdeburg gGmbH
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Sangerhausen、Saxony-Anhalt、ドイツ、06526
- HELIOS Klinik Sangerhausen
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Schönebeck、Saxony-Anhalt、ドイツ、39218
- AMEOS Klinikum Schönebeck GmbH
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Saxony-Anhat
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Merseburg、Saxony-Anhat、ドイツ、06217
- Carl-von-Basedow-Klinikum Merseburg
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：usual care
routine care and case management
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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proportion of eligible patients undergoing adjuvant chemo therapy
時間枠：8 weeks after hospital discharge/ chrirurgical resection
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8 weeks after hospital discharge/ chrirurgical resection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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disease-free survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：at Baseline
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using the EORTC INPATSAT-32
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at Baseline
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協力者と研究者
捜査官
- スタディディレクター：Margarete Landenberger, Prof. Dr.、Martin-Luther-University Halle-Wittenberg, Medical Faculty, Institute for Health and Nursing Science
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。