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Walk on: A Community-based Approach to Increase Physical Activity Among Men Treated for Colorectal Cancer

13. September 2018 aktualisiert von: 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.

Studienübersicht

Status

Zurückgezogen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1N 6N5
        • University of Ottawa

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

Inclusion Criteria:

  1. Men 18 years of age or older;
  2. Have completed treatment for colorectal cancer <1 year;
  3. Willing to provide informed consent to participate in this study and willing to follow the study protocol;
  4. Have the ability to walk without the use of an assistive device (including a cane) or the help of another person;
  5. Able to read and understand English;
  6. Medically cleared to participate in the walking program as determined by their referring Wellness Beyond Cancer Program healthcare provider.

Exclusion Criteria:

  1. 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;
  2. Uncontrolled hypertension (systolic blood pressure>200 mm Hg and/or diastolic blood pressure >110 mm Hg);
  3. The use of supplemental oxygen;
  4. Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
  5. History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
  6. Hip fracture, hip or knee replacement in the past 6 months;
  7. Currently enrolled in another study involving a physical activity intervention.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Group-based walking
Participants will engage in one supervised outdoor group-based walking session per week for the 8 week program.
Verhalten: Group-based walking
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment rates
Zeitfenster: Through study completion, an average of 8 weeks
The number of men who enrol in the study out of the number who are referred.
Through study completion, an average of 8 weeks
Retention rates
Zeitfenster: Through study completion, an average of 8 weeks
The number of men who complete the intervention and all scheduled assessments.
Through study completion, an average of 8 weeks
Adherence rates
Zeitfenster: Through study completion, an average of 8 weeks
The number of walking sessions men engage in out of the total recommended as part of the intervention.
Through study completion, an average of 8 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported physical activity (over the past 7 days) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Quality of Life: Functional Assessment of Cancer Therapy (FACT)-Colorectal (Ward et al., 1999; Yost et al. 2005)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported quality of life from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Cognitive Functioning: FACT-Cognitive Function (Wagner et al., 2004)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported cognitive functioning from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported affect from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Depression: Center for Epidemiologic Studies Depression Scale 10-item Revised (Eaton et al., 2004; Radloff, 1977)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported depressive symptoms from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Social Support: Relatedness to Others in Physical Activity Scale (Wilson & Bengoechea, 2010)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported perceptions of social support from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Physical Self-Perceptions: Physical Self Description Questionnaire Short-Form (Marsh et al., 2010)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported physical competence, confidence, and self-esteem from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Stress: Perceived Stress Scale (Cohen et al., 1982)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported perceptions of stress from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Change in Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue Scale (Yellen et al., 1997)
Zeitfenster: Baseline (week 0) and post-intervention (week 8)
Change in participants' self-reported perceptions of fatigue from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 8)
Participants' Overall Experiences: Qualitative Interviews
Zeitfenster: Post-intervention (week 8)
Participants' perspectives on how the intervention contributed to their behavioural, physical, psychological and social functioning, as well as their overall quality of life.
Post-intervention (week 8)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Ottawa

Ermittler

  • Hauptermittler: Jennifer Brunet, PhD, University of Ottawa

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Oktober 2017

Primärer Abschluss (Voraussichtlich)

30. September 2018

Studienabschluss (Voraussichtlich)

30. September 2018

Studienanmeldedaten

Zuerst eingereicht

23. Juli 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juli 2017

Zuerst gepostet (Tatsächlich)

28. Juli 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. September 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. September 2018

Zuletzt verifiziert

1. September 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • WBCP:PA/CR

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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