Mindfulness Intervention in Reducing Anxiety in Patients Who Have Been Treated for Gynecologic Cancer
2019年11月13日 更新者：University of Wisconsin, Madison
Mindfulness-Based Interventions in Patients Treated for Gynecologic Cancer - Impact on Patient Reported Outcomes and Immunologic Correlates
This pilot clinical trial studies how well a mindfulness-based stress reduction (MBSR) intervention works in reducing anxiety in patients who have undergone treatment for gynecologic cancer but no longer have any sign of disease.
Gynecologic cancer is cancer of the female reproductive tract, which includes the cervix, endometrium, fallopian tubes, ovaries, uterus, and vagina.
Side effects from treatment for these cancers may include anxiety, fatigue, depression, and sexual function changes.
Mindfulness training uses meditation and yoga to help patients focus on breathing, bodily sensations, and mental awareness.
This may help decrease patients' stress and anxiety and improve their quality of life, and may also help their immune system.
調査の概要
状態
完了
詳細な説明
Patients are randomized to 1 of 2 Arms.
ARM I (INTERVENTION): Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7. The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class. Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
ARM II (WAIT-LIST CONTROL): Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
After completion of study, patients are followed up at 8 weeks (at completion of study) and 5 months (3 months from study completion).
研究の種類
介入
入学 (実際)
38
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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Wisconsin
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Madison、Wisconsin、アメリカ、53705
- University of Wisconsin Carbone Cancer Center
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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
女性
説明
Inclusion Criteria:
- Diagnosis of any invasive gynecologic cancer without evidence of disease.
- Gynecologic cancer treatment (e.g., surgery, chemotherapy, radiation therapy) was completed within 5 years prior to date of enrollment.
- Able to speak, read and write English
- ECOG Performance Status between 0 and 3
- Subjects must have a phone.
- Experiencing 2 or more of the following symptoms felt to be associated (per the patient) with gynecologic cancer or previous gynecologic cancer treatment: anxiety (worry or feeling stressed), cognitive impairment (difficulty concentrating, focusing, memory loss), depression, existential/spiritual distress (hopelessness, lack of meaning in life, lack of peace), fatigue, pain, and sexual dysfunction. These symptoms may be new or worsened since cancer diagnosis. Both symptoms fomr this list must have been present one week prior to eligibility assessment, with worst severity rating greater than or equal to 3 (0-10 scale) for at least 1 of the 2 symptoms
- Expected to continue cancer care at UWCCC for the duration of the study.
Exclusion Criteria:
- Undergone cancer treatment (excluding hormonal therapy or biological maintenance therapy) in the 4 weeks prior to enrollment
- Expected to require cancer treatment, other than biologic or hormonal maintenance therapy, during the course of the study
- Any other cancer present within the last 5 years (other than gynecologic cancer under study and non-melanoma skin cancer)
- Practicing mindfulness meditation for an average of more than 1 hour/week or have taken mindfulness training in the past
- Documented history of Alzheimer's disease, dementia, or other neurologic deficit that could impact decision-making
- Prisoner or incarcerated
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：並列代入
- 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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実験的：Arm I (MBSR intervention)
Patients undergo an 8-week MBSR course, comprising weekly 2.5 hour classes and one 6-hour Saturday class at week 6 or 7.
The MBSR program involves instruction in mindfulness meditation and yoga, and gives homework assignments involving practicing the well-being techniques taught in class.
Patients are required to record and report time spent on home practice in a journal daily, and receive a weekly reminder to report their home practice.
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The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
他の名前：
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介入なし：Arm II (control)
Patients do not participate in the intervention, but are given the option to be placed on a waitlist for the MBSR course and may complete it within 6 months after the final study visit.
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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 anxiety
時間枠：Baseline to up to 5 months
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Measured by the 8-item anxiety subscale of the PROMIS scale.
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Baseline to up to 5 months
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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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Change in depression
時間枠：Baseline to up to 5 months
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Measured by PROMIS subscale for depression.
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Baseline to up to 5 months
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Change in fatigue
時間枠：Baseline to up to 5 months
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Measured by PROMIS subscale for fatigue.
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Baseline to up to 5 months
|
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Change in sleep disturbance
時間枠：Baseline to up to 5 months
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Measured by PROMIS subscale for sleep disturbance.
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Baseline to up to 5 months
|
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Change in sexual function
時間枠：Baseline to up to 5 months
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Measured by Female Sexual Function Profile and Global Satisfaction with Sex Life questionnaire.
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Baseline to up to 5 months
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Change in existential/spiritual distress
時間枠：Baseline to up to 5 months
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measured by Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being Scale (FACIT-SP-12 version 4)
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Baseline to up to 5 months
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Change in cognitive function
時間枠：Baseline to up to 5 months
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Measured by the NIH Toolbox Assessments
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Baseline to up to 5 months
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Change in cortisol levels
時間枠：Baseline to up to 5 months
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The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
|
Baseline to up to 5 months
|
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Change in levels of pro-inflammatory cytokines
時間枠：Baseline to up to 5 months
|
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
|
Baseline to up to 5 months
|
|
Change in immune cell phenotypes
時間枠：Baseline to up to 5 months
|
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
|
Baseline to up to 5 months
|
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Change in NK cell function
時間枠：Baseline to up to 5 months
|
The biobehavioral link between MBSR intervention-related Quality of Life changes and immune cell function will be explored.
|
Baseline to up to 5 months
|
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：Ryan Spencer、University of Wisconsin, Madison
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)
2015年11月18日
一次修了 (実際)
2019年6月20日
研究の完了 (実際)
2019年6月20日
試験登録日
最初に提出
2015年8月4日
QC基準を満たした最初の提出物
2015年8月4日
最初の投稿 (見積もり)
2015年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2019年11月15日
QC基準を満たした最後の更新が送信されました
2019年11月13日
最終確認日
2019年7月1日
詳しくは
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