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Reducir el comportamiento sedentario durante el tratamiento del cáncer: el estudio RedSedCan (RedSedCan)

28 de septiembre de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

210

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Suecia
      • Uppsala, Suecia
        • Reclutamiento
        • Akademiska sjukhuset
      • Västerås, Suecia
        • Reclutamiento
        • Västmanlands sjukhus

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

Todos

Descripción

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.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention

Participants receive a digital support intervention
Conductual: 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.
Sin intervención: Control

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sedentary behavior time
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sedentary behavior bouts
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Demographic variables
Periodo de tiempo: Baseline

Study specific questions
Baseline
Diagnoses
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

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.

Enlaces Útiles

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)

1 de marzo de 2025

Finalización primaria (Estimado)

31 de diciembre de 2029

Finalización del estudio (Estimado)

31 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

19 de noviembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

2 de diciembre de 2024

Publicado por primera vez (Actual)

5 de diciembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

28 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2020/1120

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan 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.

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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