Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors
Feasibility of a Technology-based Intervention to Reach Inactive Breast Cancer Survivors and Objectively Track Step Activity.
This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically.
The investigators hypothesize that at the end of 12-weeks, participants randomized to the intervention group will engage in more weekly steps than those participants randomized to the comparison group.
調査の概要
詳細な説明
More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known to negatively impact both morbidity and mortality, and is especially pronounced among cancer survivors. Self-directed interventions targeting inactivity among breast cancer survivors often report clinically insignificant behavior change. More successful behavior change interventions have suggested that tailoring and, more recently, the fostering of intrinsic motivation, may have improved outcomes. However, no interventions to date have utilized these approaches to increase physical activity among sedentary cancer survivors.
AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a sample of sedentary women to determine message acceptability.
AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of weekly steps taken among sedentary post-treatment breast cancer survivors compared to a 12-week, targeted intervention.
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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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- Lineberger Comprehensive Cancer Center/ University of North Carolina
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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:
- Female
- 40-70 years of age
- History of breast cancer stage I-II
- 2-10 years post-treatment
- Sedentary
- Technology access and skills
- Regular access to personal computer/ broadband internet and email account
- Comfortability using internet, and web-based tools
- US Resident
Exclusion Criteria:
- Concurrent enrollment in another physical activity/ lifestyle/ weight loss intervention program/study
- Current secondary cancer diagnosis/ treatment
- Inability to ambulate
- Refusal to wear personal activity monitor (FitBit Ultra) for the duration of the study
- Engaging in regular moderate to vigorous physical activity
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：防止
- 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：Tailored Group
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Participants will receive tailored emails.
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アクティブコンパレータ：Targeted Group
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Participants will receive targeted emails.
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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 |
|---|---|---|
|
Difference in weekly steps between intervention and comparison group at the end of the intervention (week 12).
時間枠：12 weeks
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The primary outcome will be measured using weekly step data as measured by a commercially available accelerometer.
The primary outcome will be the difference in weekly steps between the intervention and comparison group at the end of the intervention (week 12).
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12 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Leanne Kaye, PhD、University of North Carolina
- スタディディレクター：Dianne Ward, Ed.D、University of North Carolina
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。