Shared Decision Making for Patients With HER2-negative Metastatic Breast Cancer (SDM-01) (SDM-01)
Implementing Shared Decision Making (SDM) For HER2 Negative Metastatic Breast Cancer Patients (SDM-01 Study)
Background and Purpose:
Deciding on the best treatment for HER2-negative metastatic breast cancer (MBC) is a complex process. Patients often have unique values and preferences regarding their care and quality of life. Shared Decision Making (SDM) is a communication process where doctors and patients work together to make healthcare choices. This study aims to evaluate whether providing specific SDM training to oncologists and educational materials to patients can improve the quality of these conversations and make the treatment process feel more focused on patient goals.
Study Design and Procedures:
This is a prospective, randomized multicenter study involving oncology centers in Italy. A total of 120 patients starting their first-line therapy for HER2-negative metastatic breast cancer will participate. Participants and their oncologists will be assigned to one of two main study arms:
The SDM Trained Group: This group includes different approaches, such as formal SDM training for oncologists, providing educational materials (booklet and video) to patients, or a combination of both.
The Usual Care Group: In this group, patients and oncologists follow standard care processes without specific SDM training or additional educational materials.
What to Expect:
Patients in all groups will be asked to complete standardized questionnaires (such as CollaboRATE, SURE, and SDM-Q-9) at two time points: on Day 1 after the first encounter with the oncologist and at a 6-month follow-up. These surveys will measure the patient's perception of the decision-making process, their satisfaction with the treatment choice, and their overall quality of life.
Goal:
The researchers hypothesize that educational training for patients and/or physicians will improve the quality of conversations about MBC therapy. If successful, this study may provide tools to enhance patient adherence to treatment and overall well-being.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Confirmed diagnosis of metastatic breast cancer (MBC).
HER2-negative status (as per ASCO/CAP guidelines).
Patients scheduled to receive or currently receiving their first-line therapy for metastatic disease.
Age ≥ 18 years.
Willingness to participate in the study and provide written informed consent.
Exclusion Criteria:
Diagnosis of early-stage breast cancer (non-metastatic).
HER2-positive metastatic breast cancer.
Age < 18 years.
Refusal to sign the study-specific informed consent form.
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：ヘルスサービス研究
- 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：Physician and Patient Trained
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
実験的：Physician Only Trained
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
実験的：Patient Only Educated
|
Comprehensive Shared Decision Making (SDM) program.
No drug treatment will be administered in this study.
The intervention consists of two components: 1) A virtual training program for oncologists on SDM communication skills; 2) Educational materials for patients (booklet and video) to support treatment choice.
Depending on the assigned study arm, participants may receive one, both, or neither of these components.
|
|
介入なし：Usual Care
Patients and oncologists follow standard care processes.
No specific training on Shared Decision Making (SDM) is provided to the oncologist, and no additional educational materials are given to the patient.
Both parties will only complete the study questionnaires to evaluate the baseline quality of decision-making.
|
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 |
|---|---|---|
|
SDM-Q-9 (9-item Shared Decision Making Questionnaire)
時間枠：Baseline and 6 months
|
A 9-item scale used to measure the level of shared decision-making from the patient's perspective.
Each item is scored on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree).
The total score is transformed to a scale of 0 to 100, where higher scores indicate a higher level of involvement in the decision-making process.
|
Baseline and 6 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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。