Promoting a Healthier Lifestyle Among Breast Cancer Survivors
Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors
調査の概要
詳細な説明
Participants will be randomly assigned to one of two groups. One group of breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors. The other group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
Participants will have three consultations with a health counselor. The first two consultations will take place in-person and the third consultation will take place via telephone. Participants will also be asked to complete questionnaires assessing their physical and mental well-being, their dietary habits, and their physical activity habits at four time-points: in-person during their first study visit, via mail or through an online survey 6 weeks later, in-person 12 weeks later, and via mail or through an online survey 24 weeks later. Additionally, during their first study visit and 12 weeks later, their level of aerobic fitness will be tested by having participants walk a long hallway for six minutes.
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
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Florida
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Tampa、Florida、アメリカ、33612
- H. Lee Moffitt Cancer Center and Research Institute
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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:
- ≥ 18 years of age;
- be capable of speaking and reading English;
- be diagnosed with stage 0-II breast cancer;
- be currently disease free;
- have been treated surgically for breast cancer;
- have completed chemotherapy and/or radiotherapy at least three months but no more than two years prior;
- be physically able to exercise as measured by the Physical Activity Readiness Questionnaire-Revised (Thomas, Reading, & Shephard, 1992) ;
- be currently physically inactive as measured by the Godin Leisure Time Exercise Questionnaire (Godin & Shepard, 1985); and
- be contemplating increasing physical activity as measured by the Exercise Stages of Change - Short Form (Marcus, Selby, Niaura, & Rossi, 1992).
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 |
|---|---|
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実験的：動機付け面接
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Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.
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アクティブコンパレータ：Physical Activity Counseling
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The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
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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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Number of Participants Who Increased Activity After Motivational Interviewing
時間枠：24 Weeks Per Participant
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The primary objective of this study is to evaluate the efficacy of a brief Motivational Interviewing (MI) based intervention, relative to a time and attention control intervention (healthy lifestyle counseling), in promoting physical activity among early-stage breast cancer survivors who are physically inactive but are contemplating increasing their level of physical activity.
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24 Weeks Per Participant
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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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Number of Participants With Desired Impact on Symptoms After Motivational Interviewing
時間枠：24 Weeks Per Participant
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The secondary objectives of this study are (1) to examine the impact of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness; and
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24 Weeks Per Participant
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Number of Participants With Desired Effects From Increased Physical Activity
時間枠：24 Weeks Per Participant
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(2) to explore whether the degree of change in physical activity acts as a mediator of the expected benefits of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness.
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24 Weeks Per Participant
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協力者と研究者
捜査官
- 主任研究者：Paul B. Jacobsen, Ph.D.、H. Lee Moffitt Cancer Center and Research Institute
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
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 (見積もり)
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。
乳がんの臨床試験
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Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital; The First Affiliated... と他の協力者完了
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