Pragmatic Research of Acupuncture and Counseling eXtended to Inpatient Services (PRACXIS)
2021年10月21日 更新者：University of California, San Francisco
Non-pharmacologic Approaches to Relieve Pain and Symptom Distress Among Diverse Hospitalized Cancer Patients
Despite improved assessment and pharmacologic management, cancer pain is still undertreated.
Using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs.
However, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited.
Patients want to know "How can I get the most pain relief with the fewest side effects?"
This study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.
調査の概要
詳細な説明
This study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. Study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination.
Participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. Patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers).
The study will be conducted as a pragmatic clinical trial at two hospitals to address these aims:
- Determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management.
- Determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects.
- Examine stakeholder perspectives on non-pharmacologic approaches to pain management.
研究の種類
介入
入学 (実際)
448
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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California
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San Francisco、California、アメリカ、94143
- University of California, San Francisco
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San Francisco、California、アメリカ、94110
- Zuckerberg San Francisco General Hospital
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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:
- Patients admitted to University of California San Francisco (UCSF) or Zuckerberg San Francisco General (ZSFG) with a malignant solid tumor
- Speak Cantonese, English, or Spanish
- Have an anticipated stay of ≥ 48 hours
- Be aged 21 or older
- Have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled
Exclusion Criteria:
- Acupuncture contraindication
- Unstable medical condition (e.g., severe pulmonary disease, myocardial infarction)
- Admission to the psychiatric ward (e.g., for severe depression)
- Inability to consent (e.g., cognitive impairment)
- Prior involvement with the study (e.g., readmissions)
- Platelets < 50,000 microliters
- Absolute neutrophil count < 500 microliters
- C. difficile infection
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：ランダム化
- 介入モデル：階乗代入
- 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 |
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介入なし：Treatment As Usual
Participants will receive routine care consisting of usual analgesic medications for pain in adults with cancer.
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アクティブコンパレータ：Acupuncture
Along with routine pain medications, participants will be offered daily acupuncture treatments for up to four days.
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A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol.
Treatments will provided daily for up to four hospital days.
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アクティブコンパレータ：Pain Counseling
Along with routine pain medications, participants will receive evidence-based psychosocial support through education and counseling provided by qualified study staff.
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Participants will receive sessions with a counselor trained in pain management.
The pain counselor will explain, review, and discuss the contents of a Pain Control booklet.
Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
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アクティブコンパレータ：Acupuncture and Pain Counseling
Along with routine pain medications, participants will be offered daily acupuncture treatments and pain counseling for up to four days as described above.
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A licensed acupuncturist will assess participants' symptoms and administer acupuncture needles in accordance with traditional Chinese medicine principles and the study protocol.
Treatments will provided daily for up to four hospital days.
Participants will receive sessions with a counselor trained in pain management.
The pain counselor will explain, review, and discuss the contents of a Pain Control booklet.
Sessions will include pain assessment, pain education, and coping skills, provided daily for up to four hospital days.
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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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Change in worst pain intensity assessed by the NRS
時間枠：Daily for up to four hospital days
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Participants' worst level of pain in the past 24 hours on a 0-10 numeric rating scale (NRS), 0= no pain and 10= worst pain imaginable
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Daily for up to four hospital days
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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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Use of opioids during hospital stay
時間枠：Hospital stay (average length of stay = 5 days)
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Total and average daily use of opioids based on morphine milligram equivalence
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Hospital stay (average length of stay = 5 days)
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Presence and severity of common side effects
時間枠：Daily for up to four hospital days
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Nausea, vomiting, agitation, and sedation
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Daily for up to four hospital days
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Cancer-related distress
時間枠：Daily for up to four hospital days
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Single item measure developed by the National Comprehensive Cancer Network.
Participants are asked to indicate the number that best describes how much distress they are experiencing in the past week including today, 0=no distress and 10=extreme distress.
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Daily for up to four hospital days
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Health-related quality of life assessed by the EuroQol EQ-5D-3L (EQ-5D-3L)
時間枠：Daily for up to four hospital days
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The EuroQol EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 3 levels: no problems, some problems, extreme problems.
The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
The EuroQol visual analogue scale (EQ VAS) records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Detailed scoring instructions are available: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf
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Daily for up to four hospital days
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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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Pain Treatment Satisfaction Scale
時間枠：Assessed once at the end of hospital stay (average length of stay = 5 days)
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The Pain Treatment Satisfaction Scale includes subscales of satisfaction with information, medical care, effectiveness, and side effects with reliability ranging from 0.83 to 0.92.
Each of the subscales are scored from 0 to 100 with higher scores indicating greater satisfaction.
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Assessed once at the end of hospital stay (average length of stay = 5 days)
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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。
捜査官
- 主任研究者：Maria T Chao, DrPH, MPA、University of California, San Francisco
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)
2019年1月17日
一次修了 (実際)
2021年9月30日
研究の完了 (実際)
2021年9月30日
試験登録日
最初に提出
2018年8月30日
QC基準を満たした最初の提出物
2019年4月3日
最初の投稿 (実際)
2019年4月5日
学習記録の更新
投稿された最後の更新 (実際)
2021年10月22日
QC基準を満たした最後の更新が送信されました
2021年10月21日
最終確認日
2021年10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
- 17-23446
- NCI-2018-02204 (レジストリ識別子：NCI Clinical Trials Reporting Program (CTRP))
- 18801 (University of California, San Francisco)
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?
いいえ
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。
痛みの臨床試験
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Dexa Medica Group完了