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Nurse AMIE: Addressing Metastatic Individuals Everyday (NurseAMIE)

2022年1月19日 更新者:Kathryn Schmitz、Milton S. Hershey Medical Center

Nurse AMIE: A Tablet Based Supportive Care Platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)

Determine the acceptability and feasibility of a supportive care software platform to improve quality of life and function in metastatic breast cancer patients. Acceptability will be defined as the proportion of women offered the intervention who agree to participate. Feasibility will be 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.

調査の概要

状態

完了

詳細な説明

Goals of the Nurse AMIE software program are to regularly assess psychosocial, functional, and symptom needs among metastatic breast cancer patients and to provide appropriate interventions via YouTube style videos, weekly phone calls with a patient navigator at Penn State, and appropriate referrals to phone or in person consultations as needed. The proposed Nurse AMIE software program will allow for the provision of resources (YouTube style videos, audio files, exercises) to intervene on many of the common symptoms and challenges experienced by metastatic patients. This is an identified need on the part of both metastatic patients and their medical care teams. Finally, it will also allow patient navigators to check in with patients, reviewing responses to surveys, discerning whether new or different interventions are needed, and connecting women to palliative care and other services if additional care is warranted.

研究の種類

介入

入学 (実際)

21

段階

  • 適用できない

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

    • Pennsylvania
      • Hershey、Pennsylvania、アメリカ、17033
        • Penn State Cancer Institute

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

18年歳以上 (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:

  • 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

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
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.

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.

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
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.
3 Months

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
The proportion of patients who agree to participate among those deemed eligible and cleared by oncologist.
3 Months

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

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
Quality of Life: Functional Assessment of Cancer Therapy- Breast
時間枠:Through study completion, an average of 9 months

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
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.
Through study completion, an average of 9 months
Sleep: Sleep Quality Assessment (PSQI)
時間枠:Through study completion, an average of 9 months

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
Fatigue: Brief Fatigue Inventory
時間枠:Through study completion, an average of 9 months
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.
Through study completion, an average of 9 months

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。

捜査官

  • 主任研究者:Kathryn H Schmitz, PhD、Penn State University

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 (実際)

2019年3月1日

一次修了 (実際)

2020年9月1日

研究の完了 (実際)

2020年9月1日

試験登録日

最初に提出

2019年6月4日

QC基準を満たした最初の提出物

2019年6月4日

最初の投稿 (実際)

2019年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2022年1月21日

QC基準を満たした最後の更新が送信されました

2022年1月19日

最終確認日

2022年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • STUDY00011444

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いいえ

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いいえ

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いいえ

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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