Walk on: A Community-based Approach to Increase Physical Activity Among Men Treated for Colorectal Cancer
2018年9月13日 更新者：Jennifer Brunet、University of Ottawa
Walk on: A Community-based Approach to Promote Participation in Physical Activity Among Men Treated for Colorectal Cancer
In Canada, over 102,900 men are diagnosed with cancer each year. Of these, 81,000 are diagnosed with colorectal cancer and an estimated 65% are expected to survive the disease for at least 5 years. Men who have completed treatment for colorectal cancer face many adverse physical, cognitive, psychological, and social effects. The Wellness Beyond Cancer Program at The Ottawa Hospital is a cancer survivorship program that helps people who have completed treatment for cancer, including men diagnosed with colorectal cancer, manage these effects. The Wellness Beyond Cancer Program does this through education and referral to supportive care services and programs offered throughout the city of Ottawa.
Group-based physical activity programs are one of the varied services and programs available to adults diagnosed with cancer in Ottawa. Such programs are offered through the Ottawa Regional Cancer Foundation (http://www.ottawacancer.ca) and Breast Cancer Action Ottawa (http://bcaott.ca). Research on these programs show that group-based physical activity can improve disease and treatment-related effects while promoting overall quality of life amongst women with cancer. However, few of these programs have targeted men, even though their needs and preferences have been shown to be very different from women. While men diagnosed with colorectal cancer might also benefit from group-based physical activity programs offered in the community, it is not known if such programs would effectively reach them and what the impact would be on their quality of life after cancer treatment.
It is believed that a men's group-based walking program could be an effective way to reach men and promote quality of life after cancer treatment. Therefore, a sustainable 8-week group-based walking program was developed. This project will seek to explore the feasibility and potential benefits of the program among men who have completed treatment for colorectal cancer and who are referred to the program from staff at the Wellness Beyond Cancer Program in a prospective single-arm trial.
調査の概要
研究の種類
介入
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
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Ontario
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Ottawa、Ontario、カナダ、K1N 6N5
- University of Ottawa
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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
18年歳以上 (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
男
説明
Inclusion Criteria:
- Men 18 years of age or older;
- Have completed treatment for colorectal cancer <1 year;
- Willing to provide informed consent to participate in this study and willing to follow the study protocol;
- Have the ability to walk without the use of an assistive device (including a cane) or the help of another person;
- Able to read and understand English;
- Medically cleared to participate in the walking program as determined by their referring Wellness Beyond Cancer Program healthcare provider.
Exclusion Criteria:
- Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus;
- Uncontrolled hypertension (systolic blood pressure>200 mm Hg and/or diastolic blood pressure >110 mm Hg);
- The use of supplemental oxygen;
- Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
- History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
- Hip fracture, hip or knee replacement in the past 6 months;
- Currently enrolled in another study involving a physical activity intervention.
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：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 |
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実験的：Group-based walking
Participants will engage in one supervised outdoor group-based walking session per week for the 8 week program.
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The walking prescription will be progressive in nature.
The program will begin with participants walking for approximately 20 minutes in weeks 1-3.
This will gradually increase to approximately 30 minutes in weeks 4-6.
Finally, this will increase to 45-60 minutes in weeks 7-8.
The program will promote walking at a moderate intensity as assessed by Borg's Rating of Perceived Exertion scale.
Each session will be preceded by a brief warm-up and followed by a brief cool-down period.
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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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Recruitment rates
時間枠：Through study completion, an average of 8 weeks
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The number of men who enrol in the study out of the number who are referred.
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Through study completion, an average of 8 weeks
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Retention rates
時間枠：Through study completion, an average of 8 weeks
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The number of men who complete the intervention and all scheduled assessments.
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Through study completion, an average of 8 weeks
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Adherence rates
時間枠：Through study completion, an average of 8 weeks
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The number of walking sessions men engage in out of the total recommended as part of the intervention.
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Through study completion, an average of 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 |
|---|---|---|
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Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported physical activity (over the past 7 days) from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Quality of Life: Functional Assessment of Cancer Therapy (FACT)-Colorectal (Ward et al., 1999; Yost et al. 2005)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported quality of life from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported cognitive functioning from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported affect from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Depression: Center for Epidemiologic Studies Depression Scale 10-item Revised (Eaton et al., 2004; Radloff, 1977)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported depressive symptoms from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Social Support: Relatedness to Others in Physical Activity Scale (Wilson & Bengoechea, 2010)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported perceptions of social support from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Physical Self-Perceptions: Physical Self Description Questionnaire Short-Form (Marsh et al., 2010)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported physical competence, confidence, and self-esteem from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Stress: Perceived Stress Scale (Cohen et al., 1982)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported perceptions of stress from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Change in Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (Yellen et al., 1997)
時間枠：Baseline (week 0) and post-intervention (week 8)
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Change in participants' self-reported perceptions of fatigue from baseline to post-intervention.
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Baseline (week 0) and post-intervention (week 8)
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Participants' Overall Experiences: Qualitative Interviews
時間枠：Post-intervention (week 8)
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Participants' perspectives on how the intervention contributed to their behavioural, physical, psychological and social functioning, as well as their overall quality of life.
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Post-intervention (week 8)
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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
捜査官
- 主任研究者：Jennifer Brunet, PhD、University of Ottawa
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997 Feb;13(2):63-74. doi: 10.1016/s0885-3924(96)00274-6.
- Marsh HW, Martin AJ, Jackson S. Introducing a short version of the physical self description questionnaire: new strategies, short-form evaluative criteria, and applications of factor analyses. J Sport Exerc Psychol. 2010 Aug;32(4):438-82. doi: 10.1123/jsep.32.4.438. Erratum In: J Sport Exerc Psychol. 2010 Dec;32(6):909-11.
- Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999 May;8(3):181-95. doi: 10.1023/a:1008821826499.
- Yost KJ, Cella D, Chawla A, Holmgren E, Eton DT, Ayanian JZ, West DW. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol. 2005 Dec;58(12):1241-51. doi: 10.1016/j.jclinepi.2005.07.008. Epub 2005 Oct 13.
- Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R), in The Use of Psychological Testing for Treatment Planning and Outcomes Assessment, M.E. Maruish, Editor. 2004, Lawrence Erlbaum: Mahwah, NJ. p. 363-377.
- Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement, 1977. 1: p. 385-401.
- Wagner L, Lai J-S, Cella D, Sweet J, Forrestal S. Chemotherapy-related cognitive deficits: development of the FACT-Cog instrument. Ann Behav Med, 2004. 27: p. S10.
- Wilson PM, Bengoechea EG. The relatedness to others in physical activity scale: evidence for structural and criterion validity. Journal of Applied Biobehavioral Research, 2010. 15(2): p. 61-87.
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)
2017年10月5日
一次修了 (予想される)
2018年9月30日
研究の完了 (予想される)
2018年9月30日
試験登録日
最初に提出
2017年7月23日
QC基準を満たした最初の提出物
2017年7月25日
最初の投稿 (実際)
2017年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2018年9月17日
QC基準を満たした最後の更新が送信されました
2018年9月13日
最終確認日
2018年9月1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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