Web-based Mindfulness Meditation in Reducing Distress in Participants With Metastatic Gastrointestinal Cancer and Their Caregivers
2020年10月8日 更新者：University of California, San Francisco
Being Present 2.0: Web-Based Mindfulness Meditation for Gastrointestinal Cancer Patients and Caregivers
This trial studies how well web-based mindfulness meditation works in reducing distress in both participants with gastrointestinal cancer that has spread to other parts of the body, and their caregivers.
Web-based mindfulness meditation, which uses audio exercises and interactive webinars taught by trained meditation instructors, may help participants with GI cancer and their caregivers reduce distress and improve their quality of life.
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To determine the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic gastrointestinal (GI) cancer receiving chemotherapy and their caregivers.
SECONDARY OBJECTIVES:
I. Estimate the efficacy of an 8-week web-based mindfulness meditation program with live webinars among patients with a metastatic GI cancer receiving chemotherapy and their caregivers.
OUTLINE:
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks. Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
After completion of study, participants are followed up at 8 weeks.
研究の種類
介入
入学 (実際)
68
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、94115
- University of California, San Francisco
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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
18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:
- ELIGIBLE PATIENTS: Carry a diagnosis of a metastatic GI cancer
- ELIGIBLE PATIENTS: Anticipate receiving chemotherapy for at least 12 weeks total from the time of recruitment
- ELIGIBLE PATIENTS: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
- ELIGIBLE PATIENTS: Have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2
- ELIGIBLE PATIENTS: Be able to speak and read English
- ELIGIBLE PATIENTS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- ELIGIBLE PATIENTS: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
- ELIGIBLE PATIENTS: Be able to provide informed consent
- ELIGIBLE CAREGIVERS: Be a spouse/partner, other family member, or a close friend of a patient who consented to participate in the Being Present 2.0 study
- ELIGIBLE CAREGIVERS: Be able to speak and read English
- ELIGIBLE CAREGIVERS: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- ELIGIBLE CAREGIVERS: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
- ELIGIBLE CAREGIVERS: Be able to provide informed consent
Exclusion Criteria:
- Have a current meditation practice (> 2 episodes or > 1 hour total, weekly)
- Be currently enrolled in a stress reduction program
- Have extensive hearing loss such that ability to participate in the study would be impaired
- Have participated in the original Being Present pilot study (BP1)
- Be caregivers of patients who decline Being Present 2.0 (BP2) study participation
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：なし
- 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）
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：Supportive Care (web-based mindfulness meditation)
Participants practice with web-based mindfulness meditation over 10-15 minute guided audio sessions for 5 days a week for 8 weeks.
Participants also attend meditation webinars over 60 minutes once a week, for 8 weeks.
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補助研究
Receive web-based mindfulness meditation
他の名前：
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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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Feasibility as assessed by evaluating recruitment rate
時間枠：At end of enrollment (Up to 1 year)
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Number of participants approached who consent to participate
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At end of enrollment (Up to 1 year)
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Feasibility as assessed by evaluating rate of refusal to participate
時間枠：At end of enrollment (Up to 1 year)
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Number of participants refusing to consent.
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At end of enrollment (Up to 1 year)
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Feasibility as assessed by rate of attrition
時間枠：At 8 weeks post end of enrollment (Up to 1 year)
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Number of participants dropping out after start of intervention for any reason.
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At 8 weeks post end of enrollment (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
時間枠：At 8 weeks after study start (Up to 1 year)
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Number of times participant practices during study, documented via website data capture
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At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
時間枠：At 8 weeks after study start (Up to 1 year)
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Number of times participant watches recorded webinars, documented via website data capture
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At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
時間枠：At 8 weeks after study start (Up to 1 year)
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Number of times patient participates in live webinars, documented via roll-call.
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At 8 weeks after study start (Up to 1 year)
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Acceptability as assessed by adherence to practice instructions
時間枠：At 8 weeks after study start (Up to 1 year)
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Average duration of meditation session (measured in minutes), documented via website data capture.
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At 8 weeks after study start (Up to 1 year)
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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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Efficacy as assessed by National Comprehensive Cancer Network (NCCN) Distress Thermometer
時間枠：At baseline, week 4 and week 8 after study start (Up to 1 year)
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0 to 10, with 10 being the worst level of distress
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS)
時間枠：At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by a Five Facet Mindfulness Questionnaire Short (FFMQ-SF)
時間枠：At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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Efficacy as assessed by a "Are You at Peace?" one-item spiritual probe
時間枠：At baseline, week 4 and week 8 after study start (Up to 1 year)
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At baseline, week 4 and week 8 after study start (Up to 1 year)
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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。
協力者
捜査官
- 主任研究者：Chloe Atreya, MD、University of California, San Francisco
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。
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)
2018年5月7日
一次修了 (実際)
2019年10月31日
研究の完了 (実際)
2019年10月31日
試験登録日
最初に提出
2018年4月30日
QC基準を満たした最初の提出物
2018年5月16日
最初の投稿 (実際)
2018年5月18日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月9日
QC基準を満たした最後の更新が送信されました
2020年10月8日
最終確認日
2020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
- 174534 (Integrated Research Application System)
- NCI-2018-00622 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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
米国で製造され、米国から輸出された製品。
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。