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

13 de setembro de 2018 atualizado 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.

Visão geral do estudo

Status

Retirado

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Macho

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Group-based walking
Participants will engage in one supervised outdoor group-based walking session per week for the 8 week program.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Recruitment rates
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Ottawa

Investigadores

  • Investigador principal: Jennifer Brunet, PhD, University of Ottawa

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de outubro de 2017

Conclusão Primária (Antecipado)

30 de setembro de 2018

Conclusão do estudo (Antecipado)

30 de setembro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

23 de julho de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de julho de 2017

Primeira postagem (Real)

28 de julho de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de setembro de 2018

Última verificação

1 de setembro de 2018

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • WBCP:PA/CR

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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