Physical Activity Promotion in Cancer Follow-Up Care
Physical Activity Promotion In Cancer Follow-up Care
This study aims at testing the efficacy of a physical activity (PA)intervention in an outpatient oncology setting. We plan to compare Brief Advice for PA (MD advice plus contact control) vs. Extended Advice (MD advice plus telephone-based PA counseling by research staff) over 3 months among 300 women who have completed treatment for breast cancer in the past 2 years.
Specific Aims: The primary aim is to examine the effects of oncologists' advice on PA plus telephone counseling (Extended Advice) vs. oncologists' advice (Brief Advice) alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer.
Secondary aims include examining a) the effects of the two interventions on participants' moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on participants' physical functioning, fatigue, vigor and quality of life (QOL) at 3, 6 and 12 months, and c) the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients.
調査の概要
詳細な説明
Background: With improved survival rates, there are growing numbers of cancer survivors. These individuals report impaired physical functioning, anxiety and depressed mood, fatigue, and reduced quality of life after treatment. In addition, they may be at increased risk for cardiovascular disease, obesity, osteoporosis and future cancers. Prior research has demonstrated that moderate-intensity physical activity (PA) can improve enhance physical functioning, reduce fatigue and improve vigor among cancer patients and those who have completed medical treatments. These efforts have not been integrated with the healthcare system. Data support the role of primary care providers in promoting PA among their sedentary patients; the role of oncologists in encouraging patients to become physically active has not been examined.
Objectives: This study aims at testing the efficacy of a PA intervention in an outpatient oncology setting. We plan to compare Brief Advice for PA (MD advice plus contact control) vs. Extended Advice (MD advice plus telephone-based PA counseling by research staff) over 3 months among 300 women who have completed treatment for breast cancer in the past 2 years.
Specific Aims: The primary aim is to examine the effects of oncologists' advice on PA plus telephone counseling (Extended Advice) vs. oncologists' advice (Brief Advice) alone on minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer.
Secondary aims include examining a) the effects of the two interventions on participants' moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on participants' physical functioning, fatigue, vigor and quality of life (QOL) at 3, 6 and 12 months, and c) the acceptability of the interventions to the oncologists and the usefulness of the interventions to patients.
Study Design: A randomized, controlled trial will be conducted in outpatient oncology practices in Rhode Island. Within this setting, the oncologists and research staff will offer a 3 month, theoretically-based intervention to increase moderate-intensity PA among 300 sedentary women aged 18 and older who attend cancer follow-up visits. The unit of randomization will be at the patient level.
Cancer Relevance: If the data are promising, the study lays the groundwork for improving cancer recovery by integrating a brief PA intervention into follow-up care for cancer survivors. This study offers the potential to improve the follow-up care for cancer survivors by encouraging them to becoming physically active, to help reduce the emotional and physical side-effects of cancer and its treatment, as well as possibly reduce their risk for other chronic diseases such as cardiovascular disease and osteoporosis.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Centers for Behavioral and Preventive Medicine, Miriam Hospital
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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:
1) female aged >18 years, 2) completed primary and adjuvant treatment for breast cancer (patients on hormone treatment such as Tamoxifen will be eligible). Women on chemotherapy will become eligible 6 months after treatment completion, and will remain eligible up to 10 years posttreatment; 3) <10 years since treatment completion, 4) able to read and speak English, 5) provide consent for medical chart review to extract disease and treatment variables, 6) able to walk unassisted, are 7) sedentary defined as: currently not meeting ACSM/CDC criteria (Pate et al, 1995) for moderate-intensity activity (>30 mins. per day on >5 days per week) or vigorous-intensity activity (>20 mins. on >3 days per week), and 8) have access to a telephone. -
Exclusion Criteria:
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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
- 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:Exercise Counseling
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プラセボコンパレーター:Contact Control
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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 |
時間枠 |
---|---|
Minutes of moderate-intensity PA at 3 months among 300 sedentary women who have completed treatment for breast cancer.
時間枠:3 months
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3 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Secondary aims include examining a) the effects of the two interventions on participants' moderate-intensity PA at 6 and 12 months, b) the effects of the interventions on participants' physical functioning, fatigue, vigor and quality of life (QOL) at
時間枠:6 and 12 months for physical activity
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6 and 12 months for physical activity
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Bernardine Pinto, Ph.D.、The Miriam Hospital
出版物と役立つリンク
一般刊行物
- Pinto BM, Papandonatos GD, Goldstein MG. A randomized trial to promote physical activity among breast cancer patients. Health Psychol. 2013 Jun;32(6):616-26. doi: 10.1037/a0029886.
- Pinto BM, Dunsiger S, Waldemore M. Physical activity and psychosocial benefits among breast cancer patients. Psychooncology. 2013 Oct;22(10):2193-9. doi: 10.1002/pon.3272. Epub 2013 Mar 15.
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
本研究に関する用語
キーワード
その他の研究ID番号
- American Cancer Society (119421-RSGT-10-113-01-CPPB)
- RSGP-03-423
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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