このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients

2017年11月20日 更新者:Cindy Matsen、University of Utah

An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients

The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process.

調査の概要

詳細な説明

The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret.

The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses:

Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that:

1. Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter.

2. The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process.

  1. Patients who achieve role concordance will have better QOL and less decision regret at early (2 to 6 weeks) and later (6 months) time points after the clinic visit.
  2. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.
  3. Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments

研究の種類

介入

入学 (実際)

100

段階

  • 適用できない

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:

  • All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.

Exclusion Criteria:

  • Men with breast cancer.
  • Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.

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:他の
  • 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
介入なし:The non-intervention control group
In the non-intervention control group, providers are blind to the patient's preferred decision making role.
実験的:The intervention group
The provider will be informed of the patient preference in treatment decision making (preferred role) and have a discussion about this with the patient in the intervention group.
The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.

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
Decision role concordance before and after a surgical consultation
時間枠:The estimated period is 3 hours (before and immediately after a surgical consultation)
The primary outcome measures the changes from patient's preferred role in baseline (before a surgical consultation) to the perception of whether the patient achieved the preferred role (immediately after a surgical consultation) in the surgical consultation.
The estimated period is 3 hours (before and immediately after a surgical consultation)
Decision role concordance of provider and patient
時間枠:This is an one-time measurement (Immediately after a surgical consultation)
It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.
This is an one-time measurement (Immediately after a surgical consultation)

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient's satisfaction with the decision making process
時間枠:immediately after a surgical consultation
Satisfaction with the decision making process will be measured directly after the clinic encounter using a modified version of the Holmes-Rovner Satisfaction with Decision scale. The scale uses a Likert-type ranking of 6 items related to decision making, with 1 being strongly disagree and 5 being strongly agree.
immediately after a surgical consultation
Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups
時間枠:This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.
Quality of life will be assessed using the (FACT-B) questionnaire. FACT-B measures 27 items in five different areas: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to this patient population. FACT-B is measured on the scale from 0 to 4, with a total minimum score of 0 and maximum score of 144.
This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.
The Decision Regret outcome
時間枠:The scale will be administered at 2 weeks and 6 months after initial clinic visit.
The decision regret outcome will be measured using the Decision Regret Scale. The Decision Regret Scale is is a 5 item scale with items ranked on a 5-point Likert-type scale and added together with higher score indicating more regret.
The scale will be administered at 2 weeks and 6 months after initial clinic visit.
Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement
時間枠:4 months after initial clinic visit
The outcome of patient involvement at the clinic encounter will be measured using the OPTION scale. This scale measures 12 item from 0 to 4, with 0 being "this behavior is not observed" to 4 "This behavior is exhibited to a very high standard"
4 months after initial clinic visit
completion or intention to complete therapies
時間枠:6 months after initial clinic visit
Group differences in completion or intention to complete recommended therapies will be assessed at 6 months after the clinic visit through chart review of all participants' charts.
6 months after initial clinic visit

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:Cindy Matsen, MD、University of Utah

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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)

2016年3月7日

一次修了 (実際)

2017年1月31日

研究の完了 (実際)

2017年8月9日

試験登録日

最初に提出

2017年10月13日

QC基準を満たした最初の提出物

2017年11月20日

最初の投稿 (実際)

2017年11月22日

学習記録の更新

投稿された最後の更新 (実際)

2017年11月22日

QC基準を満たした最後の更新が送信されました

2017年11月20日

最終確認日

2017年11月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

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。

乳がんの臨床試験

  • Tianjin Medical University Cancer Institute and...
    Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者
    完了
  • Novartis Pharmaceuticals
    終了しました
    メラノーマ | 高度なEGFR変異体非小さな細胞肺cancer(NSCLC) | KRAS G12変異NSCLC | 食道扁平上皮がん(SCC) | ヘッド/ネックSCC | 進行した胃腸間質腫瘍(GIST) | 進行したNRAS/BRAFT WT皮膚黒色腫
    アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
  • Jonsson Comprehensive Cancer Center
    National Cancer Institute (NCI); Highlight Therapeutics
    積極的、募集していない
    平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件
    アメリカ
購読する