Reduce Sedentary Behavior During Cancer Treatment - the RedSedCan Study

NCT ID: NCT06719206

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2029-06-01

Brief Summary

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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 self-management program 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

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Description of the project

This project is about investigating the effect of a digital self-management program to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. The self-management program 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 self-help program 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 self-management program 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 self-management program. 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

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Breast Cancer Colorectal Cancer (CRC) Prostate Cancer Neoadjuvant Therapy Adjuvant Therapy

Keywords

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sedentary behavior behavior change intervention Randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Participants receive a digital self-management intervention

Group Type EXPERIMENTAL

Digital self-management program

Intervention Type 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.

Control

Control condition. Individuals receive the care as usual provided by the healthcare only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Region Västmanland

UNKNOWN

Sponsor Role collaborator

Centrallasarettet Västerås

UNKNOWN

Sponsor Role collaborator

Region Uppsala

UNKNOWN

Sponsor Role collaborator

Mälardalen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Petra von Heideken Wågert, Professor

Role: PRINCIPAL_INVESTIGATOR

Mälardalen University

Central Contacts

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Petra von Heideken Wågert, Professor

Role: CONTACT

Phone: +46 (0)21-10 3188

Email: [email protected]

Anna Henriksson

Role: CONTACT

Email: [email protected]

Related Links

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Other Identifiers

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2020/1120

Identifier Type: -

Identifier Source: org_study_id