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Reduza o comportamento sedentário durante o tratamento do câncer - o estudo RedSedCan (RedSedCan)

28 de setembro de 2026 atualizado por: Mälardalen University

Summary

Reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. Therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital support intervention during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Description of the project

This project is about investigating the effect of a digital support intervention to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The digital support intervention has been developed with patients and researchers and consists of existing high-quality technology that provides support for setting and following goals. The people who use the digital support intervention also receive support from a physiotherapist to set goals for reduced sedentary time and get to choose which activities will replace the time spent sedentary.

The goal of the project

The goal of the project is to investigate the effects of a digital support intervention on reduced sedentary and well-being during ongoing cancer treatment, both in the short and long term. In addition, the project will study the health-economic effects, and climate benefits of using the digital support intervention. By focusing on reducing a sedentary lifestyle and replacing it with daily activities and/or physical activity, the health of individuals is expected to be positively affected in the short term through, for example, increased well-being and reduced side effects from cancer treatment, and the long term through a reduced risk of developing complications and new illness related to the cancer treatment, such as cardiovascular disease.

Tipo de estudo

Intervencional

Inscrição (Estimado)

210

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.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Suécia
      • Uppsala, Suécia
        • Recrutamento
        • Akademiska sjukhuset
      • Västerås, Suécia
        • Recrutamento
        • Västmanlands sjukhus

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

Tudo

Descrição

Inclusion Criteria:

  • Individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in Uppsala and Västerås, Sweden.

Exclusion Criteria:

  • Individuals diagnosed with dementia.
  • Individuals diagnosed with severe psychiatric disease.
  • Individuals with severe loss of vision, or communicative ability.
  • Individuals who cannot walk independently indoors with or without a walking aid.
  • Individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention

Participants receive a digital support intervention
Comportamental: Digital self-management program

The program consists of commercially available technologies, e.g. applications including behavour change techniques for reducing sedentary behavior (SB) (i.e. self-monitorization of physical activity, reminders for breaking SB/doing physical activity, and providing feedback on physical activity/breaks from SB) and a webpage containing information and tips (provided in short videos and text) regarding how to reduce SB. The participants will be receive help with setting goals for reducing time spent in sedentary/being active and help with planning for what activities to do to replace time in sedentary. Participants will then have access to the webpage and download the application to their smartphones. Follow-up meetings with the physiotherapist (digital or physical) will be conducted after 2, 8 and 12 weeks after start of intervention.
Sem intervenção: Control

Control condition. Individuals receive the care as usual provided by the healthcare only.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Sedentary behavior time
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

The Axivity accelerometer is used for measuring the primary outcome of sedentary time, i.e. mean time spent in sedentary behavior/day.
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sedentary behavior bouts
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

The Axivity accelerometer is used for measuring sedentary bouts, i.e. mean number of bouts/day and mean bouts time/day.
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
Physical activity
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

The Axivity accelerometer is used for measuring physical activity mean time/day and mean time spent in low-, moderate and high intensity physical activity.
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
Health-related quality of life
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Patient reported health related quality of life will be assessed with European Organization for Research and Treatment of Cancer QLQ C 30 and diagnose specific modules BR23, PR26 and CR29.
At baseline, 3-months, 6 months, 12 months and 24 months.
Health-related quality of life
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Patient reported health related quality of life will be assessed with EQ5D, and used for calculation of Quality Adjusted Life Years.
At baseline, 3-months, 6 months, 12 months and 24 months.
Cancer related fatigue
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Patient reported outcome cancer related fatigue is measured with Brief Fatigue Inventory.
At baseline, 3-months, 6 months, 12 months and 24 months.
Fear of movement
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Patient reported outcome Fear of movement is assessed with Cancer specific Tampa Scale for Kinesiophobia.
At baseline, 3-months, 6 months, 12 months and 24 months.
Changes in health
Prazo: At 3-months, 6 months, 12 months and 24 months.

Patient reported outcome Changes in health is assessed with Patient Global Impression of Change Scale.
At 3-months, 6 months, 12 months and 24 months.
Work ability
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Selected and adapted questions from Work Ability Index are used for assessing patient reported outcome work ability.
At baseline, 3-months, 6 months, 12 months and 24 months.
Self-efficacy for reducing sedentary behavior
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Study specific question is used for assessing patient reported outcome of Self-efficacy for reducing sedentary behavior.
At baseline, 3-months, 6 months, 12 months and 24 months.
Perceived support from peers
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Study specific question is used for assessing patient reported outcome of Perceived support from peers.
At baseline, 3-months, 6 months, 12 months and 24 months.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Demographic variables
Prazo: Baseline

Study specific questions
Baseline
Diagnoses
Prazo: At baseline

Data regarding cancer diagnose and if any, co-morbid conditions, are gathered from medical records or Swedish national quality registers.
At baseline
Cancer treatment
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Data regarding planned and received oncological and surgical cancer treatment (type, dose, treatment start and end date of treatment) and any treatment related side-effects are gathered from medical records and Swedish quality registers.
At baseline, 3-months, 6 months, 12 months and 24 months.
Health care costs
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Data regarding outpatient visits, hospitalization and prescribed medication is gathered from Swedish national quality registers.
At baseline, 3-months, 6 months, 12 months and 24 months.
Costs of intervention
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Data regarding cost of application use and any cost for physical activity is gathered from study records and patient reported by study specific questions.
At baseline, 3-months, 6 months, 12 months and 24 months.
Sick leave
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Data regarding sick leave, i.e. total number of days being on sick leave gathered from the Swedish insurance fund (data on sick leave more than 14 days) and patient reported study specific questions (data on sick leave less than 14 days). Data will be gathered from 6 months prior baseline (study specific questions are administered at baseline and register data will be gathered at baseline but will include any data 6 months prior baseline).
At baseline, 3-months, 6 months, 12 months and 24 months.
Adherence
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Adherence to the intervention is assessed by Axivity accelometer and patient reported study specific questions.
At baseline, 3-months, 6 months, 12 months and 24 months.
Green house gas emissions
Prazo: At baseline, 3-months, 6 months, 12 months and 24 months.

Green house emissions will be compared between the intervention and control group and estimated using a life cycle analysis of the technology used in the intervention, self-reported changes in climate behavior, and emissions from healthcare.
At baseline, 3-months, 6 months, 12 months and 24 months.

Colaboradores e Investigadores

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

Patrocinador

Mälardalen University

Colaboradores

Uppsala University
Uppsala University Hospital
Uppsala County Council, Sweden
Region Västmanland
Centrallasarettet Västerås

Investigadores

  • Investigador principal: Petra von Heideken Wågert, Professor, Mälardalen University

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.

Links úteis

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)

1 de março de 2025

Conclusão Primária (Estimado)

31 de dezembro de 2029

Conclusão do estudo (Estimado)

31 de dezembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

19 de novembro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de dezembro de 2024

Primeira postagem (Real)

5 de dezembro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2020/1120

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual medical information may not be shared with other researchers if the research questions are not within the scope of the current approved Swedish Ethical Review Board application (and any amendments) for this research. Only pseudonymous information may be shared after approval has been provided from the Swedish Ethical Review Board.

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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