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NCT Number: NCT06719206

Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study

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.

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Key information

Conditions

Breast Cancer Adjuvant Therapy Behavior Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoadjuvant Therapy Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Sedentary Behavior Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akademiska sjukhuset, Uppsala, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital self-management program

Behavioral

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.

Primary outcomes

  1. Sedentary behavior time

    Time frame: 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.

Secondary outcomes

  1. Sedentary behavior bouts

    Time frame: 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.

  2. Physical activity

    Time frame: 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.

  3. Health-related quality of life

    Time frame: 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.

  4. Health-related quality of life

    Time frame: 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.

  5. Cancer related fatigue

    Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.

    Patient reported outcome cancer related fatigue is measured with Brief Fatigue Inventory.

  6. Fear of movement

    Time frame: 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.

  7. Changes in health

    Time frame: 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.

  8. Work ability

    Time frame: 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.

  9. Self-efficacy for reducing sedentary behavior

    Time frame: 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.

  10. Perceived support from peers

    Time frame: 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.

Other outcomes

  1. Demographic variables

    Time frame: Baseline

    Study specific questions

  2. Diagnoses

    Time frame: At baseline

    Data regarding cancer diagnose and if any, co-morbid conditions, are gathered from medical records or Swedish national quality registers.

  3. Cancer treatment

    Time frame: 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.

  4. Health care costs

    Time frame: 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.

  5. Costs of intervention

    Time frame: 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.

  6. Sick leave

    Time frame: 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).

  7. Adherence

    Time frame: 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.

  8. Green house gas emissions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Henriksson

CONTACT

[email protected]

Petra von Heideken Wågert, Professor

CONTACT

[email protected]

+46 (0)21-10 3188

Sponsors and collaborators

Lead sponsor

Mälardalen University

Other

Collaborators

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

Registry information

Acronym: RedSedCan

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Dec 5, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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