A Home-Based Study to Enhance Activity in Breast Cancer Survivors
There is a well-documented association between physical activity & risk for breast cancer development and recurrence. It is known that exercise interventions have been effective at increasing physical activity levels in breast cancer survivors. Knowing that breast cancer survivors are less active than non-cancer patients, a less active lifestyle places them at risk of obesity and poor overall health, which in turn also increases risk of cancer and cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known that hormones and other inflammatory markers play a role.
This study has three goals:
- To investigate the feasibility of a home intervention designed to reduce sedentary behavior.
- Describe the effects of the intervention on levels of sedentary behavior, physical activity, and symptoms.
- Assess cost of the intervention.
調査の概要
詳細な説明
There is a well-documented association between physical activity and risk for breast cancer development and recurrence. Exercise training interventions have been effective at increasing physical activity levels in breast cancer survivors, however they require 1) a large degree of patient initiative to achieve positive health outcomes associated with sustained behavioral change and 2) facilities and oversight that may be prohibitive in a clinical setting. Although most activity-based research to date has focused on increasing levels of moderate to vigorous physical activity (MVPA) for breast cancer survivors, large epidemiological studies suggest that breast cancer survivors are also more sedentary when compared to non-cancer controls. A recent meta-analysis of controlled intervention trials designed to promote physical activity among sedentary cancer survivors found that none of the trials within the scope of the review succeeded in achieving 75% or better adherence to prescribed exercise guidelines, leading the authors to question whether shifting the target of intervention from MVPA to reductions in sedentary time might be a more realistic goal. Recent research suggests that interventions designed to reduce sedentary time in breast cancer survivors have the potential to yield clinically meaningful health benefits, especially for individuals at higher risk for sedentary behaviors, however the optimal method of intervention is not clear.
Aim 1: Feasibility of the intervention Assess the feasibility of an intervention designed to reduce sedentary behavior in breast cancer survivors. The behavioral intervention will involve the review of a 7-day baseline snapshot of sedentary behavior and physical activity patterns, combined with tailored activity prompts described over the following 6 weeks.
Aim 2: Effects of the intervention Aim 2a: Describe a preliminary range of effect sizes of the intervention on levels of sedentary behavior, physical activity and symptoms of cancer survivorship (e.g. cancer related fatigue).
Aim 2b: Evaluate the relationship between change in sedentary behavior and change in cancer-relevant outcomes, such as fatigue and biomarkers of cancer recurrence (e.g. IGF-1, Leptin), following the reduced sedentary time intervention.
Aim 3: Assessment of intervention components Aim 3a: Quantitatively assess overall cost of the intervention and its individual components, dose delivered and dose received by intervention participants Aim 3b: Quantitatively describe intervention participants' perspectives on the impact of the individual intervention components, including which components appeared most useful for reducing sedentary time.
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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Massachusetts
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Springfield、Massachusetts、アメリカ、01109
- Baystate Medical Center
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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:
- Stage I-III breast cancer survivors 20-80 who have completed primary treatment (surgery, radiation and/or chemotherapy) greater than 6 months but less than 5 years ago. Patients may be on adjuvant hormonal therapy
- BMI > 25 (overweight or class I/II obese)
- Not meeting current guidelines for regular exercise as defined by less than 150 minutes a week of moderate to vigorous physical activity
- No gain or loss of >10% body weight over the prior 6 months.
Exclusion Criteria:
- Known diabetes
- Known coronary artery disease
- Pregnancy
- Any injury that would limit mobility or require use of assisted mobility devices
- Weight gain or loss of >10% body weight over the prior 6 months
- Greater than 150 minutes a week of moderate to vigorous physical activity
- Inability to provide informed consent
- Non-english speaking
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:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
---|---|
他の:Reduced Sedentary Time Intervention
Reduced Sedentary Time Intervention (RSTI)
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Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant.
For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time.
This program has been successful in sedentary overweight office workers and investigators will use similar techniques.
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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 |
---|---|---|
Sedentary Time
時間枠:8 weeks
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Change in minutes/day of sedentary time as recorded by ActivPal in all 25 participants pre and post intervention.
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8 weeks
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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 |
---|---|---|
Activity Level
時間枠:8 weeks
|
Change in Activity level as recorded by Actigraph monitor in all 25 participants
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8 weeks
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Glucose
時間枠:8 weeks
|
Change in fasting glucose ( mmol/L)in all 25 participants
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8 weeks
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Insulin
時間枠:8 weeks
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Change in insulin (pmol/L) in all 25 participants
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8 weeks
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Total cholesterol
時間枠:8 weeks
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Change in total cholesterol (mmol) in all 25 participants
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8 weeks
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High density lipoprotien cholesterol
時間枠:8 weeks
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Change in high density lipoprotein cholesterol (mmol) in all 25 participants
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8 weeks
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Triglyceride
時間枠:8 weeks
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Change in triglycerides (mmol) in all 25 participants
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8 weeks
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Body Mass Index
時間枠:8 weeks
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Change in Body Mass Index (kg/m2) in all 25 participants
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8 weeks
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Waist Circumference
時間枠:8 weeks
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Change in waist circumference in cm in all 25 participants
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8 weeks
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Systolic Blood pressure
時間枠:8 weeks
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Change in systolic blood pressure measured in mmHg in all 25 participants
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8 weeks
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Diastolic Blood pressure
時間枠:8 weeks
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Change in diastolic blood pressure measured in mmHg in all 25 participants
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8 weeks
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Cancer-related fatigue measured by change in PROMIS short form 8a in all 25 participants
時間枠:8 weeks
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8 weeks
|
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Cancer-related fatigue as measured by change in Visual Analog scale in all 25 participants
時間枠:8 weeks
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8 weeks
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Sedentary behavior self -efficacy
時間枠:8 weeks
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Change in Sedentary Behavior Self-Efficacy Scale (modified from BARSE) in all 25 participants
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8 weeks
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Change in EORTC-QLQ-C30 scores in all 25 participants
時間枠:8 weeks
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8 weeks
|
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Assessment of Intervention
時間枠:8 weeks
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Change in Assessment of Intervention questions on a scale of 1-5 in all 25 participants
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8 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Grace Makari-Judson, MD、Baystate Medical Center
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 (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。
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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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Reduced Sedentary Time Intervention (RSTI)の臨床試験
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University of MichiganNational Institute on Drug Abuse (NIDA)募集