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Recruiting NCT06719206

Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study

No phase Interventional Breast Cancer Colorectal Cancer (CRC) Prostate Cancer Neoadjuvant Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital self-management program.
Who it may be relevant to
Registry conditions: Breast Cancer, Colorectal Cancer (CRC), Prostate Cancer, Neoadjuvant Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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 spe

Primary outcome measures

  • 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.]
Secondary outcome measures (10)
  • 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.]
  • 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.]
  • Health-related quality of life [Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Health-related quality of life [Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Cancer related fatigue [Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Fear of movement [Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Changes in health [Time frame: At 3-months, 6 months, 12 months and 24 months.]
  • Work ability [Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Self-efficacy for reducing sedentary behavior [Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.]
  • Perceived support from peers [Time frame: At baseline, 3-months, 6 months, 12 months and 24 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Sweden · 2 centers
  • Akademiska sjukhuset — Uppsala
  • Västmanlands sjukhus — Västerås

Identifiers

NCT: NCT06719206 · 2020/1120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗