The Effect of Walking on Fatigue After Chemotherapy in Patients 65 and Older (S-PACT)
A Randomized, Wait-list Controlled Clinical Trial: the Effect of a Physical Activity Program on Fatigue After Potentially Curative Chemotherapy Among Cancer Survivors Age 65 or Older -- PACT (Physical Activity After Chemotherapy)
調査の概要
詳細な説明
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
- 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:
- Men and women age 65 years and older
- Histologically or cytologically confirmed cancer (hematologic or solid) at stage considered amenable to cure as assessed by the treating MD
Within 6 weeks of end of chemotherapy (all participants must have had chemotherapy treatment)
- Any radiation received must also be completed prior to randomization (if radiation treatment follows adjuvant chemotherapy, then the patient must be recruited within 6 weeks of end of radiation)
- Maintenance hormonal therapy in women with breast cancer is allowed; see exclusion criteria regarding hormonal therapy in males with prostate cancer
- Moderate to severe fatigue (>4 on BFI)
- Less than 120 minutes/week of physical activity
- English speaking
- Signed IRB approved written informed consent
- Approval from their treating physician to engage in moderate-intensity physical activity
- Patient-assessed ability to walk and engage in moderate physical activity
- Willing and able to meet all study requirements.
Exclusion Criteria:
- Receiving hormonal therapy for prostate cancer
- Unable to walk or engage in moderate-intensity physical activity
- Have BFI≤3.
- Report more than 120 minutes/week of 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:処理
- 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:Intervention
This arm will begin the Walk With Ease program after the completion of chemotherapy.
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Walk With Ease は、疲労と痛みを軽減するための関節炎財団の証拠に基づいた歩行介入です。
この介入は、1 日 30 分間、週 5 日歩くことを最終目標として、参加者を安全で快適なペースのウォーキング プログラムに導くのに役立つ自主的なプログラムです。
他の名前:
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アクティブコンパレータ:Wait List Control
The arm will begin the Walk With Ease program three months after completion of chemotherapy.
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Walk With Ease は、疲労と痛みを軽減するための関節炎財団の証拠に基づいた歩行介入です。
この介入は、1 日 30 分間、週 5 日歩くことを最終目標として、参加者を安全で快適なペースのウォーキング プログラムに導くのに役立つ自主的なプログラムです。
他の名前:
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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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To measure change in fatigue scores between intervention and wait list control arms from baseline to three months.
時間枠:Three months
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Change in fatigue will be measured using the FACIT-F.
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Three months
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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 |
---|---|---|
To measure change in fatigue scores between intervention and WLC arms from baseline to 3 months
時間枠:Three months
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This outcome will be measured by the Brief Fatigue Inventory
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Three months
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To report recruitment and retention in the study at 3 months
時間枠:Three months
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Three months
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To report recruitment and retention in the study at 6 months
時間枠:Six months
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Six months
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To measure implementation of and adherence to WWE
時間枠:Six months
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Six months
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To count the number of adverse events
時間枠:Six months
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To characterize the safety of the walking program through a review of the number and type of adverse events, including falls, reported by study participants to the Study Team.
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Six months
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To measure change in engagement of walking over time from baseline to three months.
時間枠:Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions |
Three Months
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To measure change in physical function over time from baseline to three months.
時間枠:Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Physical function as measured by SPPB |
Three Months
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To measure change in quality of life over time from baseline to three months.
時間枠:Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Quality of life as measured by FACT-G (global and subscales) and symptom scales, including PROMIS pain intensity, sleep disturbance and depression. |
Three Months
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To measure change in self-efficacy over time from baseline to three months.
時間枠:Three Months
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To evaluate the following measures at baseline and 3 months, and compare changes in these measures over time between intervention and WLC arms. Engagement in walking (total minutes per week) as measured by engagement in physical activity questions |
Three Months
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協力者と研究者
捜査官
- 主任研究者:Hyman B Muss, MD、UNC Lineberger Comprehensive Cancer Center
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 (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。
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