Exercise Intervention for Cancer Survivors
2017年1月26日 更新者:Duke University
Exercise Outcome Expectations Among Breast Cancer Survivors
This randomized controlled trial will test a multicomponent intervention to increase exercise Outcome Expectations (OEs) and assess effects of OE changes on exercise intentions and levels of exercise.
Sixty early stage breast cancer survivors will be recruited from the Duke Cancer Institute.
Participants will be randomized to the exercise OE intervention or an attention control group.
Both groups will receive the American Cancer Society diet and exercise guidelines and an accelerometer.
The intervention group will also receive an OE workbook containing self-directed activities to increase OEs by focusing on OE importance (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and accessibility (frequency with which the outcome(s) are thought of).
The attention control group will receive a workbook containing the same activities focused on diet, rather than exercise.
調査の概要
詳細な説明
This study will test a theory-based intervention to increase levels of exercise among breast cancer survivors, in order to help them self-manage their long-term treatment side effects.
The study focuses on outcome expectations (OEs), a significant yet understudied construct that is central to most behavior change theories.
OEs refer to what people expect to obtain or avoid by engaging in a behavior; thus, people exercise because they believe it will produce desired outcomes.
This randomized controlled trial will test a multicomponent intervention to increase exercise OEs and assess effects of OE changes on exercise intentions and levels of exercise.
Sixty early stage (IA to IIB) inactive breast cancer survivors will be recruited from the Duke Cancer Institute.
Participants will be randomized to the exercise OE intervention or an attention control group.
Both groups will receive the American Cancer Society diet and exercise guidelines and an accelerometer.
The intervention group will also receive an OE workbook containing self-directed activities to increase OEs by focusing on OE importance (value placed on the outcome(s)), certainty (perceived probability outcome(s) will occur); and accessibility (frequency with which the outcome(s) are thought of).
The attention control group will receive a workbook containing the same activities focused on diet, rather than exercise.
OE importance, OE certainty, OE accessibility, exercise intentions, exercise, and self-efficacy (a potential co-variate) will be assessed through online surveys at baseline, 4-, 8-, and 12-weeks post-intervention.
At each time point, accelerometer data will be collected as an objective exercise measure.
Specific aims of the study are to: (1) examine trajectories of OE importance, certainty and accessibility between participants in the OE intervention arm compared to participants in the attention control arm, across four time points: baseline, 4-, 8- and 12-weeks post-intervention; and (2) examine trajectories of exercise intentions and total weekly minutes of exercise, between participants in the OE intervention arm compared to participants in the attention control arm, across four time points: baseline, 4, 8 and 12 weeks post-intervention.
If the intervention increases exercise among breast cancer survivors it may lead to improved survivorship duration and quality of life.
The intervention can be implemented readily in clinic settings to support survivors to exercise more and thus experience better long-term outcomes.
This study also provides a foundation for a developing a nurse scientist's program of research focused on designing theory-based exercise interventions for chronically ill populations.
研究の種類
介入
入学 (実際)
64
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
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27710
- Duke University School of Nursing
-
-
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
19年~90年 (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:
- stage 1A - 2B breast cancer diagnosis;
- 2 months - 10 years status post surgery, radiation and chemotherapy;
- inactive (self-reported ≤ 150 min/wk moderate - strenuous-intensity exercise);
- no evidence of cancer recurrence;
- no pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program (e.g., severe orthopedic conditions, scheduled hip or knee replacement within 6 months, paralysis and/or dementia, unstable angina, history of myocardial infarction, congestive heart failure);
- English-speaking and writing;
- access and ability to use a computer for completion of online measures; and
- possession of smartphone
Exclusion Criteria:
None
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:単一グループの割り当て
- 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 |
|---|---|
|
実験的:exercise outcome expectation workbook
Intervention arm participants will receive: 1) the ACS exercise and diet guidelines; and 2) an exercise outcome expectation workbook.
The workbook contains self-directed activities to increase OE importance, certainty, and accessibility.
The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many positive exercise outcomes breast cancer survivors may experience.
Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist.
Accessibility will be increased by having the participant think about the association between exercise and its outcomes.
|
The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many and diverse positive outcomes breast cancer survivors may experience.
Participants will then be asked to focus on the three OEs they would most like to experience.
Each section of the OE guide contains activities to target specific OE dimensions.
Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist.
Accessibility will be increased by having the participant think about the association between exercise and its outcomes
|
|
アクティブコンパレータ:diet workbook
Attention control participants will receive via mail 1) the ACS exercise and diet guidelines; and 2) a diet workbook.
The diet workbook contains the same activities as the exercise outcome expectation workbook but is focused on diet instead of exercise.
|
The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.
|
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 |
|---|---|
|
change in OE importance, as measured by questionnaire
時間枠:baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
|
change in OE accessibility, as measured by questionnaire
時間枠:baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
|
change in OE certainty, as measured by questionnaire
時間枠:baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
change in intentions to exercise, as measured by questionnaire
時間枠:baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
|
change in total weekly minutes of exercise
時間枠:baseline 4- 8- and 12-weeks post intervention
|
baseline 4- 8- and 12-weeks post intervention
|
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。
スポンサー
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6月1日
一次修了 (実際)
2016年9月1日
研究の完了 (実際)
2016年9月1日
試験登録日
最初に提出
2015年1月23日
QC基準を満たした最初の提出物
2015年1月23日
最初の投稿 (見積もり)
2015年1月28日
学習記録の更新
投稿された最後の更新 (見積もり)
2017年1月27日
QC基準を満たした最後の更新が送信されました
2017年1月26日
最終確認日
2016年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- Pro00059469
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。