Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study (RedSedCan)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Prostate Cancer; Neoadjuvant Therapy; Adjuvant Therapy; Colorectal Cancer (CRC)
• Intervention / Treatment: Behavioral: Digital self-management program

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.

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petra von Heideken Wågert, Professor; Phone Number: +46 (0)21-10 3188; Email: petra.heideken.wagert@mdu.se
• Study Contact Backup: Name: Anna Henriksson; Email: anna.km.henriksson@uu.se

Study Locations

• Sweden
  • Uppsala, Sweden
    • Recruiting
    • Akademiska Sjukhuset
  • Västerås, Sweden
    • Recruiting
    • Västmanlands sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control condition. Individuals receive the care as usual provided by the healthcare only.
Experimental: Intervention; Participants receive a digital support intervention	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedentary behavior bouts	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	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	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	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	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	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	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	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	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	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic variables	Study specific questions	Baseline
Diagnoses	Data regarding cancer diagnose and if any, co-morbid conditions, are gathered from medical records or Swedish national quality registers.	At baseline
Cancer treatment	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	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: Mälardalen University
• Collaborators: Uppsala University; Uppsala University Hospital; Uppsala County Council, Sweden; Region Västmanland; Centrallasarettet Västerås
• Investigators: Principal Investigator: Petra von Heideken Wågert, Professor, Mälardalen University

Publications and helpful links

Helpful Links

• Offical study web page at Mälardalens University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; intervention; sedentary behavior; behavior change
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Sedentary Behavior
• Other Study ID Numbers: 2020/1120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No