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Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners (PCDM)

2026年5月21日 更新者:Allison Magnuson、University of Rochester
The purpose of this study is to determine the feasibility for a patient centered decision-making support tool for older adults with metastatic breast cancer and their care partners.

調査の概要

状態

まだ募集していません

詳細な説明

The primary objective (Aim 1) of this study will be to evaluate feasibility of utilizing the patient-centered decision-making (PCDM) tool for older adults with metastatic breast cancer (mBC). The PCDM tool has been developed by the investigators in collaboration with Manta Cares, Inc. During the development process, we have integrated Geriatric Assessment (GA), completed fully by patients, into the PCDM tool, along with potential supportive care strategies (e.g., recommendations) that could be considered by patients and their care partners if areas of impairment are noted on the GA embedded into the PDCM tool. Feasibility of the adapted PCDM tool will be assessed both quantitatively and qualitatively, and through mixed methods (integrating quantitative and qualitative data) to provide a deeper understanding of aspects of implementation across settings.

研究の種類

介入

入学 (推定)

150

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。

研究連絡先

研究場所

    • New York
      • Rochester、New York、アメリカ、14620
        • University of Rochester

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

  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

Patient Inclusion Criteria:

  1. A diagnosis of metastatic breast cancer
  2. Age 65 or older
  3. Currently receiving systemic treatment for metastatic breast cancer or considering a plan to initiate systemic treatment for metastatic breast cancer
  4. Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
  5. Able to provide informed consent

Care Partner Inclusion Criteria:

  1. Age 18 or older
  2. Able to speak and read English (because the Manta Cares platform is presently only offered in English only)
  3. Able to provide informed consent
  4. Verbal permission from patient to enroll their designated care partner

Exclusion Criteria:

Patient Exclusion Criteria:

  1. Early-stage breast cancer
  2. Diagnosis of any other cancer besides metastatic breast cancer

Care Partner Exclusion Criteria:

1. Verbal permission from patient to enroll care partner not received.

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:非ランダム化
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

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
Patient and care partner Acceptability of Intervention (AIM)
時間枠:Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Intervention Appropriateness Measure (IAM)
時間枠:Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Feasibility of Intervention (FIM)
時間枠:Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Measure different aspects of intervention implementation. The AIM, IAM, and FIM measures were jointly developed through a consensus process involving 63 experts (e.g., implementation scientists, health professionals), and psychometric properties for the three scales have been established. All three scales were developed to evaluate fit or match of a potential intervention (acceptability measure evaluates personal fit to the individual, appropriateness measure evaluates the societal or technical fit, and the feasibility measure evaluates practical fit. Each scale has 4-items with a 5-point Likert scale response (total score 4-20 for each measure), for a total of 12 items for all three scales. No specialized training is needed to administer or score the measure and it is written at a 5th grade reading level. Although cut-off scores for interpretation are not available, higher scores indicate greater degree of acceptability, appropriateness, and feasibility respectively.
Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient Activation Measure-13 (PAM-13)
時間枠:Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The PAM 13 (originally developed as a 22-item measure and later modified to 13 items) is a valid and reliable tool to measure stages of activation, including belief that the patient role is important and having the confidence and knowledge to take action. The PAM-13 is scored 0-100, with higher scores indicating greater patient activation.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Decision Self-Efficacy Scale (DSE)
時間枠:Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The DSE scale measures self-confidence and belief in one's abilities in decision-making. The 11-item questionnaire assesses confidence in aspects such as ability to get the facts about treatment options available, including choices and benefits and side effects of choices, and ability to understand the information and ask questions/express concerns. Scoring is converted to a 0-100 scale, with higher scores indicating greater self-efficacy in decision-making. Prior studies suggest that scores below 70 were observed in patients who were significantly less likely to engage in shared decision-making and more likely to report decision regret later.43-45 This measure has been utilized in other studies of patients with advanced cancer.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Shared Decision-Making Questionnaire (SDM-Q-9)
時間枠:Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The SDM-Q-9 measures the extent to which patients are involved in the process of decision-making from the perspective of the patient. The instrument has 9 questions and is a reliable and well accepted, with high internal consistency and discriminative validity. The measure is scored on a scale of 0-100 and can be used to assess longitudinal change in shared decision making in clinical settings with an MCID of 4 points used in prior studies.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Caregiver Activation Measure (CG-PAM)
時間枠:Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Caregiver Activation Measure: A measure that was developed and validated to assess care partner's' knowledge, skill, and confidence for self-management of a chronic medical condition. Greater degrees of activation (e.g., higher degree of knowledge, skill, and confidence) can facilitate the shared decision-making process.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
Heath Care Climate Questionnaire (HCCQ)
時間枠:Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)
The HCCQ is a measure of satisfaction with communication that evaluates patients and care partners perceptions of autonomy support and shared decision making and evaluates whether they feel their oncology clinician(s) understand their perspective, provides choices, and encourage participation in decisions. The HCCQ measure has been validated in older adult populations. The full HCCQ scale has a reliability of >0.9. The six-item version will be utilized, which has demonstrated excellent internal consistency and construct validity in the oncology setting.
Time Point 1: (within 2 months of informed consent) Time Point 2: Occurs 3 months after Time Point 1 start (+/- 3 weeks) Time Point 3: Occurs 6 months after Time Point 1 start (+/- 3 weeks)

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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。

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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 (推定)

2026年8月1日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年5月14日

QC基準を満たした最初の提出物

2026年5月14日

最初の投稿 (実際)

2026年5月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月26日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年5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

  • UOCPC25063
  • STUDY00010968 (その他の識別子:University of Rochester)

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はい

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