乳がん患者の生活の質に対するヨガの効果
Effects of Two Different Online Yoga Interventions on the Quality of Life of Breast Cancer Patients Compared With Waiting List - a Three-arm Randomized Controlled Trial
This study investigates the effects of two different online yoga interventions on the health-related quality of life in breast cancer patients. Qualitative and quantitative data will be collected.
調査の概要
詳細な説明
In this randomized controlled trial breast cancer patients will be randomized into three treatment arms:
- Intervention group 1 will receive an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study mainly includes physical and relaxation exercises.
- Intervention group 2 will receive a meditative yoga intervention online including physical and meditation exercises and also ideologically neutral explanations of the ethical aspects of yoga.
- Group 3 consists of a waiting list control group, combined with the offer to participate in a yoga intervention after 6 months.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
State of Berlin
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Berlin、State of Berlin、ドイツ、14109
- 募集
- Charite University
-
コンタクト：
- Miriam Roesner
- 電話番号：030 80505 682
- メール：m.roesner@immanuel.de
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主任研究者：
- Andreas Michalsen, Prof.Dr.
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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:
- Histologically confirmed diagnosis of non-metastatic breast cancer (TNM stage I-III) up to 5 years after diagnosis
- Primary therapy completed for at least 3 months
- Limitation of the quality of life due to the cancer (indication of at least 4 out of 10 points on the numerical analogue scale)
- Willingness to participate in the study and signed informed consent.
Exclusion Criteria:
- Current or planned chemotherapy, radiation or surgery
- Severe physical or psychopharmacologically treated psychiatric comorbidity due to which a patient is unable to participate in the study
- Pregnancy/breastfeeding
- Participation in other clinical trials with behavioral, psychological, or complementary medicine interventions
- Immobility or limitation for gymnastic exercise due to orthopedic, neurologic, or other medical cause
- regular meditation practice >2x/month
- regular yoga practice >2x/month
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：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 |
|---|---|
|
実験的：Iyengar yoga
Intervention group 1 receives an Iyengar yoga intervention online in a group setting, based on the internationally renowned yoga school of B.K.S. Iyengar, which in the context of this study primarily includes physical and relaxation exercises. |
Iyengar Yoga focuses on the correct alignment of the body while practicing the physical exercises of yoga. Props are used to support the body in finding the right alignment. Relaxation is also part of this intervention. Participiants receive 1x90 min guided yoga class per week for 8 weeks and are encouraged to continue their practice at home daily for at least 30 minutes. |
|
実験的：Meditative yoga
Intervention group 2 receives an Integrative yoga intervention online including physical and meditation exercises as well as ideologically neutral explanations of the ethical aspects of Yoga. |
Meditative Yoga in the context of this study means practicing the physical exercises of yoga as well as meditation. Additionally, each week one of the yamas/niyamas, which are ethical principles to live by in the Yoga philosophy, will be presented at the beginning of each class and will form the theme of the class. Participants receive 1x90 min guided yoga class per week for 8 weeks and are encouraged to continue their practice at home daily for at least 30 minutes. |
|
介入なし：Waitlist Control Group
Group 3 consists of a waitlist control group. Participants will be offered the opportunity to attend a yoga intervention after 4 months. The patients in this waiting list control group are allowed to choose the yoga course after 6 months. |
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 |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
時間枠：Date of inclusion (baseline), after 8 weeks
|
Assessing full scale, range 0-40, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-40, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Functional Assessment of Cancer Therapy: Fatigue (FACIT-F)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-52, higher score meaning a better outcom |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Perceived Stress Scale (PSS-10)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-40, lower score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Flourishing Scale (FS-D)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 8-56, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Self-Compassion Scale (SCS-D)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Mean score of 12 items, range 1-5, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Self-Efficacy Scale (ASKU)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Mean score of 3 items, range 1-5, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Sociodemographic measures
時間枠：Date of inclusion (baseline)
|
Age, education level, personal income, household income, employment status, job description, marital status, household members, days of sick leave past 3 months |
Date of inclusion (baseline)
|
|
Behavioral questions: cigarettes
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Number of cigarettes on average per day in the last month |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Behavioral questions: alcohol
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Number of alcoholic beverages on average per week in the last month |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Expectation question
時間枠：Date of inclusion (baseline)
|
expectation of effectiveness of the intervention on a 5-point likert scale, how they expect to handle the intervention on a 5-point likert scale, higher score meaning better outcome |
Date of inclusion (baseline)
|
|
Behavioural question
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
diet |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Behavioural question 2
時間枠：Date of inclusion (baseline)
|
Practice of other mindfulness practices besides Yoga |
Date of inclusion (baseline)
|
|
Behavioural question 3
時間枠：Date of inclusion (baseline)
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Yoga styles were practiced before |
Date of inclusion (baseline)
|
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Behavioural question 4
時間枠：Date of inclusion (baseline)
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If and how often yoga is practiced regularly |
Date of inclusion (baseline)
|
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Functional Assessment of Cancer Therapy - General (FACT-G)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-108, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Yama/Niyama Questionnaire - YaNiQ
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-100, higher score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
|
Hospital Anxiety and Depression Scale (HADS)
時間枠：Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
Assessing full scale, range 0-42, lower score meaning a better outcome |
Date of inclusion (baseline), after 8 weeks, after 16 weeks, after 24 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Qualitative interviews
時間枠：8 weeks after inclusion
|
Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis. |
8 weeks after inclusion
|
|
Heart Rate Variability (HRV)
時間枠：Date of inclusion (baseline), after 8 weeks
|
24h measuring by Faros 180 |
Date of inclusion (baseline), after 8 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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。