Nurse AMIE: Addressing Metastatic Individuals Everyday (NurseAMIE)
Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
調査の概要
詳細な説明
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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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Penn State Cancer Institute
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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:
- Women with metastatic breast cancer
- ECOG performance score ≤3.
- English Speaking
- With sufficient vision/hearing or family support
- Willingness to be randomized
Exclusion Criteria:
- Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
- Patients who are receiving any other behavioral intervention
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: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 |
---|---|
実験的:Immediate Intervention
The immediate intervention group will receive the intervention at the time of consent (baseline) and will be enrolled in the intervention for a total of 6 months.
Patients will receive the tablet, a pedometer and an exercise band.
Patients will use Nurse AMIE while receiving weekly phone calls from a patient navigator.
After 90 days of the intervention observation will take place for 90 days, the patient will be asked to continue using Nurse AMIE without a patient navigator's presence.
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Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence. |
実験的:Delayed Intervention
The delayed intervention group will receive the intervention 3 months after consent (6 months of intervention with 3 months delay total of 9 months); the patient will then follow the same pattern as listed above.
The only difference is we will ask the delayed intervention group to wear a FitBit device for 1 week following consent in order to gain baseline data as to their activity/movement.
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Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator. After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence. |
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 |
---|---|---|
Feasibility of the Application: The proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
時間枠:3 Months
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Feasibility is defined as the proportion of women who consent, take a tablet home, who actually interact with the tablet and participate at least one month of the program.
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3 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 |
---|---|---|
Acceptability of the Application: The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
時間枠:3 Months
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The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
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3 Months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Quality of Life: Short Form 36
時間枠:Through study completion, an average of 9 months
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The Short Form 36 Health Survey (SF-36) is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Through study completion, an average of 9 months
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Quality of Life: Functional Assessment of Cancer Therapy- Breast
時間枠:Through study completion, an average of 9 months
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The Functional Assessment of Cancer Therapy-Breast (FACT-B), is a 44-item self-report instrument designed to measure multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B questionnaire includes 44 items, consisting of 5 subscales, all subscale items are summed to a total. The higher the score the better QOL |
Through study completion, an average of 9 months
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Physical Function: Short Physical Performance Battery
時間枠:Through study completion, an average of 9 months
|
Objectively-measured physical function will be assessed using the Short Physical Performance Battery (SPPB).
The SPPB is an accumulation of balance tests, 4-meter gait speed, and 5-chair stands.
Based on the time needed to complete the chair stands, a score is given.
A summation of scores from all tests is taken, ranging from 0 -12.
A higher score = Higher physical function.
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Through study completion, an average of 9 months
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Sleep: Sleep Quality Assessment (PSQI)
時間枠:Through study completion, an average of 9 months
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Sleep quality and sleep problems will be assessed with the validated and frequently used Pittsburgh Sleep Quality Index (PSQI). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
Through study completion, an average of 9 months
|
Pain: Brief Pain Inventory (Short Form)
時間枠:Through study completion, an average of 9 months
|
Bodily pain will be assessed using the Brief Pain Inventory- Short form (BPI-SF). The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. |
Through study completion, an average of 9 months
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Fatigue: Brief Fatigue Inventory
時間枠:Through study completion, an average of 9 months
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The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue.
An increasing focus on cancer-related fatigue emphasized the need for sensitive tools to assess this most frequently reported symptom.
The six interference items correlate with standard quality-of-life measures.
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Through study completion, an average of 9 months
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協力者と研究者
捜査官
- 主任研究者:Kathryn H Schmitz, PhD、Penn State University
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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。
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