Comparing Two Modes of Survivorship Care
Comparing Two Modes of Survivorship Care: A Randomized Trial
調査の概要
詳細な説明
Although 80% of children with cancer will be cured of their primary disease, at least 70% of survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a complication of their therapy. Most of these conditions are amenable to prevention and early intervention. In response, the Institute of Medicine strongly advised that all cancer patients should receive survivorship care with the following key elements: 1) a summary of previous cancer therapy, 2) individualized life-long screening for potential adverse therapy-related effects, and 3) education regarding desirable health behaviors. However, less than 30% of survivors receive recommended care. There is a tremendous need for research that addresses how to best implement evidence-based recommendations for this population.
Two main health care delivery models have been advocated for survivorship care, but no comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer treatment center. The second model, termed the empowered primary care model, involves patients receiving an individualized "prescription" for follow-up care prepared by a cancer survivor specialist to be implemented by the primary care doctor. Each model poses unique strengths and weaknesses. Specialty survivor clinics can be expensive and geographically inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers of patients. Primary care doctors may lack adequate expertise and time for these complex patients. Unless we know how these approaches compare with regard to quality of care and risks, advocates and policy makers will be stymied in their efforts to support the health needs of cancer survivors. This study seeks to compare subjects randomized to the empowered primary care model vs. a specialty survivor clinic.
研究の種類
入学 (実際)
段階
- 適用できない
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:
- Diagnosis of any malignancy at age <18 years and reported to Yale-New Haven Hospital or Connecticut Children's Medical Center (CCMC) tumor registry
- Currently alive and cancer-free
- Primary residence within approximately 100 miles of Yale-New Haven Hospital or CCMC
- ≥ 1 year status post completion of all cancer-related therapy
- Elapsed time of less than 12.0 years since diagnosis of malignancy
- Speaking and writing knowledge of English. For subjects <18 years, at least one parent must satisfy this requirement.
- No previous attendance at the Yale HEROS or CCMC Reach for the STARS survivorship clinics, or other specialty survivorship clinic
Exclusion Criteria:
- n/a
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:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:empowered primary care model
patients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor
|
mode of survivorship care
|
実験的:specialty survivor clinic
patient attends a specialty survivor clinic at Yale for survivorship care
|
mode of survivorship care
|
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 |
メジャーの説明 |
時間枠 |
---|---|---|
adherence to guideline-recommended surveillance (medical record abstraction)
時間枠:12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
number of newly-identified late effects of therapy (medical record abstraction)
時間枠:12 months post-intervention
|
quality of survivorship care
|
12 months post-intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
anxiety (Brief Symptom Inventory (BSI))
時間枠:12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
depression (Behavior Assessment System for Children, 2nd Edition (BASC-2))
時間枠:12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
post-traumatic stress symptoms (Post-Traumatic Stress Disorder Reaction Index (PTSD-RI))
時間枠:12 months post-intervention
|
adverse effects of receiving survivorship care
|
12 months post-intervention
|
level of physical activity (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
時間枠:12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
avoidance of tobacco (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
時間枠:12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
intake of at least five servings per day of fruits and vegetables (2008 questionnaires of the Behavioral Risk Factor Surveillance System (BRFSS))
時間枠:12 months post-intervention
|
adherence to desirable health behaviors
|
12 months post-intervention
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Nina S Kadan-Lottick, MD, MSPH、Yale School of Medicine
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 (実際)
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。
小児がんの臨床試験
-
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