Breast CancerRedSedCanNCT06719206
Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study
A study testing Digital self-management program in people with Breast Cancer and Colorectal Cancer (CRC), run by Mälardalen University at 2 sites in Sweden.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer (CRC), Prostate Cancer
- What is being tested?
- Digital self-management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Mar 2025to 31 Dec 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Henriksson contact
Sweden2 sites, 2 recruiting
- Recruiting
Akademiska sjukhuset
Uppsala
- Recruiting
Västmanlands sjukhus
Västerås
About this 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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Colorectal Cancer (CRC), Prostate Cancer, Neoadjuvant Therapy, Adjuvant Therapy
- Being tested
- Digital self-management program
- Keywords
- sedentary behavior, behavior change, intervention, Randomized controlled trial
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital self-management programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants receive a digital support intervention Receives: Behavioral: Digital self-management program |
| Control | No intervention | Control condition. Individuals receive the care as usual provided by the healthcare only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedentary behavior time
The Axivity accelerometer is used for measuring the primary outcome of sedentary time, i.e. mean time spent in sedentary behavior/day.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
Secondary outcomes (10)
Sedentary behavior bouts
The Axivity accelerometer is used for measuring sedentary bouts, i.e. mean number of bouts/day and mean bouts time/day.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.
Physical activity
The Axivity accelerometer is used for measuring physical activity mean time/day and mean time spent in low-, moderate and high intensity physical activity.
Measured: 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
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.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months.
Health-related quality of life
Patient reported health related quality of life will be assessed with EQ5D, and used for calculation of Quality Adjusted Life Years.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months.
Cancer related fatigue
Patient reported outcome cancer related fatigue is measured with Brief Fatigue Inventory.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months.
Fear of movement
Patient reported outcome Fear of movement is assessed with Cancer specific Tampa Scale for Kinesiophobia.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months.
Changes in health
Patient reported outcome Changes in health is assessed with Patient Global Impression of Change Scale.
Measured: At 3-months, 6 months, 12 months and 24 months.
Work ability
Selected and adapted questions from Work Ability Index are used for assessing patient reported outcome work ability.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months.
Self-efficacy for reducing sedentary behavior
Study specific question is used for assessing patient reported outcome of Self-efficacy for reducing sedentary behavior.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months.
Perceived support from peers
Study specific question is used for assessing patient reported outcome of Perceived support from peers.
Measured: At baseline, 3-months, 6 months, 12 months and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Mar 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västmanland, Uppsala University, Centrallasarettet Västerås, Uppsala University Hospital, Uppsala County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Petra von Heideken Wågert, Professor, Principal investigator, Mälardalen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719206
- Sponsor's protocol ID
- 2020/1120
- Acronym
- RedSedCan
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.