Walk on: A Community-based Approach to Increase Physical Activity Among Men Treated for Colorectal Cancer
13 de septiembre de 2018 actualizado por: 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.
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ontario
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Ottawa, Ontario, Canadá, K1N 6N5
- University of Ottawa
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment rates
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jennifer Brunet, PhD, University of Ottawa
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de octubre de 2017
Finalización primaria (Anticipado)
30 de septiembre de 2018
Finalización del estudio (Anticipado)
30 de septiembre de 2018
Fechas de registro del estudio
Enviado por primera vez
23 de julio de 2017
Primero enviado que cumplió con los criterios de control de calidad
25 de julio de 2017
Publicado por primera vez (Actual)
28 de julio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
13 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WBCP:PA/CR
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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