Technology Enhanced Nurse Navigator Trial (TENN Trial) (TENN)
2015年4月16日 更新者：Mercy Medical Center
Technology Enhanced Nurse Navigator Trial (TENN Trial) Phase III Randomized Controlled Trial
The purpose of the Technology Enhanced Nurse Navigator Trial (TENN) Trial is to find the best way to provide breast cancer patients with information through a computer connected to the internet.
The study will determine if giving information during treatment may help patients cope better with their treatment.
The hypothesis is that participants assigned to receive Technology-Enhanced Nurse-directed Navigation will be more likely to adhere to treatment regimens and have improved symptom management than women who have access to the education portal only.
調査の概要
詳細な説明
Treatment for breast cancer has been proven to decrease death from breast cancer.
The key to the success of treatment is getting the right dose at the right time, but many women do not receive optimum treatment.
Treatment delays, missed appointments, and failure to take medication on a regular basis lead to poorer survival from breast cancer.
In a study among low income women only 60% of women adhered to the treatment, that is, taking their medication at least 80% of the time.
Twenty percent of women, who were supposed to take 5 years of hormone treatment, had stopped their medication in the first year.
Similar problems occur with chemotherapy and radiation therapy.
Many barriers interfere with adherence to treatment, including poor symptom management, missed appointments, and cancelled appointments.
Nurse navigation can help manage and minimize symptoms, assist with appointment reminders, and answer questions to obtain optimum breast cancer treatment.
The goal of the proposed study is to rigorously test the delivery of nurse-navigation through a web-based knowledge and communication portal (Technology Enhanced Nurse-directed Navigation (TENN) for its impact on treatment adherence and symptom management.
The success of this program will be measured by improved treatment adherence, health outcome measures such as fatigue and symptom management, patient-reported quality of life, reduced distress, and patient satisfaction.
研究の種類
介入
入学 (実際)
101
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21202
- The Prevention and Research Center at Mercy Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- Enrolled in the BCCDT program for the adjuvant treatment of breast cancer,currently on medical assistance,or with an income that does not exceed 300% of the Federal Poverty Level, based on family size.
- English-speaking
- Able to give informed consent
- Not enrolled in another case-management program
- Residing within the Verizon 3G Coverage area
Exclusion Criteria:
- Non-English speaking
- Enrolled in a case management program.
- Unable to sign an informed consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Interactive navigational support
Patients on the intervention arm are provided with a netbook computer and internet access with ongoing interaction with a nurse and a social worker navigators for a one year period.
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Interactive navigational support is provided by a nurse and social worker navigators
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アクティブコンパレータ：control arm
Patients on the control arm are provided with a netbook computer, internet access and general website information but no interactive navigational support for a one year period.
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a netbook computer with internet access is provided to participants on the control arm.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Treatment Adherence
時間枠：Baseline, 6 months and 12 months
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Adherence will be determined by review of the claims data.
All claims, including hormone, chemotherapy and radiation therapy, doctor's visits, and hospitalizations, are sent through the BCCDT program.
For chemotherapy and radiation therapy, relative dose intensity (RDI) will be measured.
Adherence to hormone therapy will be measured as the medication possession ratio (MPR).A self-reported measure of adherence will be correlated with these more objective measures (Morisky et al. 1986).
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Baseline, 6 months and 12 months
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Fatigue
時間枠：Baseline, 6 months and 12 months
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Fatigue will be measured using a visual analogue scale.
The FACT-B will be used to measure quality of life.
The FACT-B is the Functional Assessment of Cancer Therapy-Breast, a reliable and valid measure for assessing subjective health-related quality of life among breast cancer survivors (Brady et al. 1997).
The FACT-B includes both the FACT-General (FACT-G) and the Breast Cancer Subscale (BCS).
The FACT-B has shown high internal consistency with a Cronbach's alpha of 0.90 (Brady et al. 1997).
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Baseline, 6 months and 12 months
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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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Patient satisfaction
時間枠：Baseline, 6 months and 12 months
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As recommended by the NCI Navigation Research Program, we will include the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer) designed to measure self-efficacy and positive attitude for cancer patients (Wolf et al. 2005).
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Baseline, 6 months and 12 months
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Quality of life
時間枠：Baseline, 6 months and 12 months
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As a measure of distress, we will use the Impact of Events scale revised (IES-R), an updated version of the original Impact of Events scale (IES) (Horowitz et al. 1979;Weiss et al. 1997).
The IES-R is a validated measure of responses to a stressful life event and addresses distress and intrusive thoughts consistent with responses to the DSM-IV diagnosis criteria of PTSD.
The IES-R is readily modified to address an event such as diagnosis of cancer or a chemotherapy-related adverse event
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Baseline, 6 months and 12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Kathy Helzlsouer, M.D., M.H.S.、The Prevention and Research Center at Mercy Medical Center
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年2月1日
一次修了 (実際)
2015年2月1日
研究の完了 (実際)
2015年2月1日
試験登録日
最初に提出
2012年5月8日
QC基準を満たした最初の提出物
2012年5月9日
最初の投稿 (見積もり)
2012年5月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年4月17日
QC基準を満たした最後の更新が送信されました
2015年4月16日
最終確認日
2015年1月1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。
Interactive navigational supportの臨床試験
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)募集
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完了
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center招待による登録
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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Dana-Farber Cancer Institute引きこもった
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University of CalgaryAlberta Health services; University of Alberta; Covenant Health完了
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Universiti Sultan Zainal Abidin募集
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Women's College HospitalRyerson University引きこもった