Brief Mindful Meditation Practice in Improving Quality of Life in Patients With Cancer Undergoing Radiation Therapy
Use of a Brief Mindful Meditation Practice in Adult Cancer Patients Receiving Radiation Therapy
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To investigate the feasibility of a clinical trial using a brief mindful meditation practice during radiation therapy.
SECONDARY OBJECTIVES:
I. To explore the measurable changes in quality of life, fatigue, and mindfulness while using a brief mindful meditation practice during radiation therapy.
OUTLINE:
Patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy.
After completion of study, patients are followed up 4-12 weeks after completion of radiation therapy.
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
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19107
- Thomas Jefferson University
-
-
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:
- Pathologically proven diagnosis of cancer any stage, based upon the following minimum diagnostic workup: History & physical examination, including documentation of Karnofsky Performance Status of 70 - 100% for at least 60 days prior to study entry
- Patients who are receiving a course of radiation therapy for curative or adjuvant intent
- Patient who have reported fatigue moderate or higher fatigue (based on the 0-10 Fatigue scale, a fatigue score of 5 or; see Appendix III) while on radiation treatment
- The patient must be an adult male or female 18 or older
- Patient must be capable to read and speak English and provide study specific informed consent prior to study entry
- No prior history of radiation therapy
- No history of or current active drug/alcohol dependence
- No patients being decisionally impaired
- Patients who have home access to a computer, or compact disc audio player
Exclusion Criteria:
- Patient is under the age of 18
- Diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer
- Patient who have reported less than moderate fatigue (based on the 0-10 Fatigue scale, a fatigue score less than 5; see Appendix III)
- Karnofsky performance status of less than 70% within the last 60 days prior to study
- Prior history of radiation therapy
- History of or active drug/alcohol dependence or abuse
- Decisionally impaired patients
- No access to a computer, or compact disc audio player
- Patient who are unable to read and speak English
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: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 |
---|---|
実験的:Brief mindful meditation practice
Patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy.
|
補助研究
Use brief mindful meditation practice
他の名前:
Ancillary studies
他の名前:
|
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 |
---|---|---|
Feasibility measured by the proportion of patients who are adherent, defined as successful completion of the course of home base brief mindful meditation practice (at least 8 out of 14 days) and completion of questionnaires at all time points
時間枠:Up to 12 weeks after completion of radiation therapy
|
The portion of patients who complete the brief mindful meditation practice intervention and questionnaires will be computed, along with a one-sided 95% exact confidence interval.
|
Up to 12 weeks after completion of radiation therapy
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Changes in quality of life assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
時間枠:Baseline to up to 12 weeks after completion of radiation therapy
|
Will be analyzed using mixed-effects linear regression.
Average changes and associated 95% confidence intervals will be estimated from these models.
|
Baseline to up to 12 weeks after completion of radiation therapy
|
Changes in fatigue assessed by FACIT-F
時間枠:Baseline to up to 12 weeks after completion of radiation therapy
|
Will be analyzed using mixed-effects linear regression.
Average changes and associated 95% confidence intervals will be estimated from these models.
|
Baseline to up to 12 weeks after completion of radiation therapy
|
Changes in mindfulness assessed by Freiburg Mindfulness Inventory
時間枠:Baseline to up to 12 weeks after completion of radiation therapy
|
Will be analyzed using mixed-effects linear regression.
Average changes and associated 95% confidence intervals will be estimated from these models.
|
Baseline to up to 12 weeks after completion of radiation therapy
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 14D.272
- 2013-107 (その他の識別子:CCRRC)
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
米国FDA規制機器製品の研究
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。
アンケート管理の臨床試験
-
Fondazione Poliambulanza Istituto Ospedalieroわからない
-
Assistance Publique - Hôpitaux de Paris完了
-
Centre Georges Francois Leclerc募集ステージ IV の非小細胞気管支肺癌であり、現在のフランスの推奨に従って第一選択治療の恩恵を受けるフランス
-
Cambridge University Hospitals NHS Foundation TrustUniversity of Cambridgeわからない筋骨格疾患 | 筋骨格系損傷
-
Centre Hospitalier Universitaire de Nīmes完了
-
Assistance Publique - Hôpitaux de Parisまだ募集していません