Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMälardalen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital self-management program
BehavioralThe 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.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.Secondary outcomes
1
Sedentary behavior bouts
The Axivity accelerometer is used for measuring sedentary bouts, i.e. mean number of bouts/day and mean bouts time/day.
Time frame
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.2
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.
Time frame
At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.3
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.
Time frame
At baseline, 3-months, 6 months, 12 months and 24 months.4
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.
Time frame
At baseline, 3-months, 6 months, 12 months and 24 months.Other outcomes
1
Demographic variables
Study specific questions
Time frame
Baseline2
Diagnoses
Data regarding cancer diagnose and if any, co-morbid conditions, are gathered from medical records or Swedish national quality registers.
Time frame
At baseline3
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.
Time frame
At baseline, 3-months, 6 months, 12 months and 24 months.4
Health care costs
Data regarding outpatient visits, hospitalization and prescribed medication is gathered from Swedish national quality registers.
Time frame
At baseline, 3-months, 6 months, 12 months and 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mälardalen University
Lead sponsor
Region Västmanland
Collaborator
Uppsala University
Collaborator
Centrallasarettet Västerås
Collaborator
Uppsala University Hospital
Collaborator
Uppsala County Council, Sweden
Collaborator
Source ClinicalTrials.gov