VOICE: Values and Options in Cancer Care (VOICE)
2019年1月8日 更新者：Ronald Epstein、University of Rochester
Randomized Controlled Trial(RCT)of Patient, Caregiver and Physician Communication Coaching in Advanced Cancer
The purpose of this study is to determine whether a combined intervention for patients, caregivers and oncologists improves communication, quality of life, and quality of care.
調査の概要
詳細な説明
The purpose of this study is to (a) determine whether a combined intervention for patients, caregivers and physicians improves communication regarding treatment choices and prognosis in cancer, (b) to determine whether the intervention improves patient and caregiver well-being, quality of life and sense of peace, and (c) to determine whether the intervention affects health services utilization.
研究の種類
介入
入学 (実際)
485
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
-
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New York
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Rochester、New York、アメリカ、14642
- University of Rochester
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-
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
21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
全て
説明
Inclusion Criteria: Physicians
- Currently in clinical practice at participating institutions
- Oncologist that cares for patients with solid tumors
- Not planning to leave the practice during the next 6 months
Inclusion Criteria: Patients
- Currently a patient of an enrolled physician
- Age 21 years or older
- Diagnosis of advanced cancer
- Able to understand spoken English (study personnel will read materials to low literacy patients)
Inclusion Criteria: Caregivers
- Caregiver of a patient currently enrolled in the study
- Age 21 years or older
- Able to understand spoken English (study personnel will read materials to low literacy patients)
Exclusion Criteria: Physicians
- Non Physicians and physicians who are not oncologists
- Oncologists who exclusively care for patients with hematological malignancies
- Prior involvement in health-related coaching interventions
Exclusion Criteria: Patients
- Unable to complete orally-administered surveys in English
- Hospitalized or in hospice care at the time of recruitment
- Prior involvement in health-related coaching interventions
- Anticipating bone marrow transplantation or diagnosed with leukemia or lymphoma
Exclusion Criteria: Caregiver
Unable to complete orally-administered surveys in English
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：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 |
|---|---|
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実験的：Intervention
Oncologists will receive communication training.
Patients will be coached to make the most of the oncologist visit.
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Oncologists will receive communication training.
Patients will be coached to make the most of the oncologist visit.
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介入なし：Control
Patients will receive usual care
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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 |
|---|---|---|
|
Mean Patient-centered Communication in Advanced Cancer Score
時間枠：3 years
|
We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions.
Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment.
We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD.
The 4-component z-scores were averaged to form the primary outcome.
A higher Z score indicates better communication.
The maximum possible Z-score ranged from -0.69 to 20.08.
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3 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13
時間枠：7 months
|
The prolonged grief (PG-13) instrument was used to measure prolonged grief.
The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion.
The range of the score is 10-50 with higher scores indicating more severe symptoms.
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7 months
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Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians
時間枠：3 years
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Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient.
They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years.
A value of 0-6 was assigned to each pair of data.
0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference.
For example if the physician said 100% and the patient said 0% the score was 6.
The mean scores were reported by arm.
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3 years
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Aim 2 Patient Well-being
時間枠：3 years
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Original McGill quality of life and the FACT-G assessment tools were used.
For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome.
For FACT-G scores range from 0 to 4. Higher score means a better outcome.
Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale.
Sum of the five standardized z-scores is the Aggregate QOL score.
A higher Z score indicates better outcomes.
The maximum possible Z-score ranged from -3.54 to 1.24.
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3 years
|
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Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment
時間枠：7 months
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SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
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7 months
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Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life
時間枠：3 years
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Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization.
The total scores ranged from 0-6 with higher scores indicated worse outcomes.
The sums of the means for the 3 outcomes were added to provide the total score.
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3 years
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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：Ronald Epstein, MD、University of Rochester
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
- Epstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373.
- Hoerger M, Epstein RM, Winters PC, Fiscella K, Duberstein PR, Gramling R, Butow PN, Mohile SG, Kaesberg PR, Tang W, Plumb S, Walczak A, Back AL, Tancredi D, Venuti A, Cipri C, Escalera G, Ferro C, Gaudion D, Hoh B, Leatherwood B, Lewis L, Robinson M, Sullivan P, Kravitz RL. Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers. BMC Cancer. 2013 Apr 9;13:188. doi: 10.1186/1471-2407-13-188.
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)
2011年4月1日
一次修了 (実際)
2017年12月31日
研究の完了 (実際)
2017年12月31日
試験登録日
最初に提出
2011年11月30日
QC基準を満たした最初の提出物
2011年12月2日
最初の投稿 (見積もり)
2011年12月5日
学習記録の更新
投稿された最後の更新 (実際)
2019年1月10日
QC基準を満たした最後の更新が送信されました
2019年1月8日
最終確認日
2019年1月1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。