Facilitating Physical Activity Behavior and Health Outcomes in Breast Cancer Patients Receiving Chemotherapy (PROACTIVE)
Breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. Few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. Developing ways to facilitate PA behavior during chemotherapy for breast cancer are necessary. This trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in PA during chemotherapy. This trial will also give Southern Alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival.
The investigators primary hypothesis is that women receiving the PA intervention resource kit will report a more positive change in self-reported PA at the end of chemotherapy treatments when compared to the group receiving standard materials.
調査の概要
詳細な説明
Primary Objective:
To compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific PA print materials (i.e., Exercise for health), a step pedometer, a step-walking guidebook (i.e., Step into survivorship), and a physical activity and step journal (INT) to a comparison group receiving a generic, two-page public health PA resource (Standard Material: SM).
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Alberta
-
Calgary、Alberta、カナダ
- 募集
- Tom Baker Cancer Centre
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Grande Prairie、Alberta、カナダ
- 募集
- Grande Prairie Cancer Centre
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Lethbridge、Alberta、カナダ
- 募集
- Lethbridge Cancer Centre
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Medicine Hat、Alberta、カナダ
- 募集
- Medicine Hat Cancer Centre
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Red Deer、Alberta、カナダ
- 募集
- Central Alberta Cancer Centre
-
-
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:
- are diagnosed with stage I -IIIA breast cancer
- are scheduled to receive neoadjuvant or adjuvant chemotherapy
- did not receive transabdominal rectus abdominus muscle (TRAM) reconstructive surgery
- are >18 years of age
- receive approval from their treating oncologist to participate
- do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).
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：PA Behavior Intervention
Physical Activity Resource Kit
|
The Intervention group (INT) will receive a Physical Activity Resource Kit which includes a step pedometer, a breast cancer-specific Physical Activity Guidebook (Exercise for health), a step pedometer resource (Step into survivorship), and a physical activity and step journal to record their daily step totals and daily physical activities. Participants will be instructed to wear their pedometer for the entire duration of the study (i.e., chemotherapy duration). |
|
アクティブコンパレータ：Standard Materials
Receive physical activity handout from the Canadian Public Health Agency
|
Participants in this usual care group will receive a generic physical activity leaflet from the Canadian Public Health Agency
|
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 |
時間枠 |
|---|---|
|
Self-reported physical activity
時間枠：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Cancer specific health related quality of life
時間枠：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Psychosocial health outcomes
時間枠：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Objective step counts (pedometer)
時間枠：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
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Chemotherapy completion rate
時間枠：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Determinants of physical activity
時間枠：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
|
Physical functioning
時間枠：Baseline, post intervention, 6 months follow up
|
Baseline, post intervention, 6 months follow up
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Jeff Vallance, PhD、Athabasca University
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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。