Decision Support Workshop for Breast Reconstruction (DSW)
Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)
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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Ontario
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Toronto、Ontario、カナダ、M5G 2C4
- Toronto General Hospital
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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:
- Patient age: 18 - 79 years at the time of consultation
- In situ or invasive biopsy confirmed breast adenocarcinoma
- Considered for immediate or delayed breast reconstruction
- First consultation for breast reconstruction
Exclusion Criteria:
- Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast
- Completion any phase of reconstruction, or for revision reconstruction
- Patient cannot read or write in English.
- Cognitive impairment or uncontrolled psychiatric diagnosis
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 |
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実験的:Decision Support Workshop
The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.
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Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
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介入なし:Standard Care
Routine pre-consultation education
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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 |
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Decision Self-efficacy Scale
時間枠:Change from baseline decision self-efficacy at 1 week after surgical consultation
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Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy). The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation. |
Change from baseline decision self-efficacy at 1 week after surgical consultation
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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 |
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Decision Conflict Scale
時間枠:Change from baseline decision conflict at 1 week after surgical consultation
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Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change.
The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).
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Change from baseline decision conflict at 1 week after surgical consultation
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Decision Preference and Decision Choice
時間枠:baseline
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Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients.
It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention.
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baseline
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Patient Involvement in Care Scale (PICS)
時間枠:T1 (1 week after surgical consultation)
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PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.
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T1 (1 week after surgical consultation)
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Satisfaction With Information (Sub-scale of BREAST-Q)
時間枠:T1 (1 week after surgical consultation)
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The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction.
The "Satisfaction with Information" Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team.
There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction.
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T1 (1 week after surgical consultation)
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Qualitative Interview Assessment
時間枠:Within three months after initial consultation
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A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview.
Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability.
Telephone interviews will be conducted by a social worker trained in qualitative methods.
All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.
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Within three months after initial consultation
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Uptake Rate of Breast Reconstruction-Service Outcome
時間枠:Six months after initial consultation
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The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)
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Six months after initial consultation
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Length of Consultation-service Outcome
時間枠:Duration of initial consultation
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The length of the initial consultation with the plastic surgeon, measured in minutes.
Consultations are expected to be between 20-60 mins.
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Duration of initial consultation
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Number of Consultations-service Outcomes
時間枠:Six months after initial consultation
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The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded.
Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.
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Six months after initial consultation
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Breast Reconstruction Knowledge Test
時間枠:Change in baseline breast reconstruction knowledge at 1 week after initial consultation
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This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.
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Change in baseline breast reconstruction knowledge at 1 week after initial consultation
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Medical Outcomes Study Social Support Survey
時間枠:baseline
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Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions).
Responses range from 1 (none of the time) to 5 (all the time).
The items in each domain were summed and then transformed to yield scores ranging from 0 to 100.
Higher scores indicate more support.
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baseline
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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 |
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Recruitment Rate-feasibility Outcome
時間枠:Duration of recruiting, expected on average two months
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As this is a pilot study, the feasibility of conducting the study is highly important.
The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.
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Duration of recruiting, expected on average two months
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Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome
時間枠:Duration of treatment-8 hours on day of treatment
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The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded.
This will be recorded directly after each day the treatment is delivered.
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Duration of treatment-8 hours on day of treatment
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Completion of Primary Outcome Measure-feasibility Outcome
時間枠:1 week after initial consultation
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Patients are to complete the primary outcome one week after initial consultation.
However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.
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1 week after initial consultation
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協力者と研究者
捜査官
- 主任研究者:Toni Zhong, MD, MHS、University Health Network, Toronto
出版物と役立つリンク
一般刊行物
- Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, Hofer SO, O'Neill AC, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29.
- Platt J, Baxter N, Jones J, Metcalfe K, Causarano N, Hofer SO, O'Neill A, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 6;14:199. doi: 10.1186/1745-6215-14-199.
便利なリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
乳がんの臨床試験
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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
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Jonsson Comprehensive Cancer CenterNational 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
Decision Support Workshopの臨床試験
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University of Wisconsin, MadisonAgency for Healthcare Research and Quality (AHRQ)募集
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Columbia UniversityNational Institute of Nursing Research (NINR); Brigham and Women's Hospital完了
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Wuerzburg University HospitalCharite University, Berlin, Germany; Goethe University; RWTH Aachen University; Technical University... と他の協力者募集
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Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)完了
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center招待による登録
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University of HawaiiNational Institute on Minority Health and Health Disparities (NIMHD)完了
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University of Alabama at BirminghamNational Cancer Institute (NCI)募集
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Madigan Army Medical CenterTelemedicine & Advanced Technology Research Center; Analytics4Medicine, Inc.わからない