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Reduzieren Sie sitzendes Verhalten während der Krebsbehandlung – die RedSedCan-Studie (RedSedCan)

28. September 2026 aktualisiert von: Mälardalen University

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

210

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Schweden
      • Uppsala, Schweden
        • Rekrutierung
        • Akademiska sjukhuset
      • Västerås, Schweden
        • Rekrutierung
        • Västmanlands sjukhus

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention

Participants receive a digital support intervention
Verhalten: 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.
Kein Eingriff: Control

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sedentary behavior time
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sedentary behavior bouts
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months. Axivity is worn for 7 consecutive days at each measurement point.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Demographic variables
Zeitfenster: Baseline

Study specific questions
Baseline
Diagnoses
Zeitfenster: At baseline

Data regarding cancer diagnose and if any, co-morbid conditions, are gathered from medical records or Swedish national quality registers.
At baseline
Cancer treatment
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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
Zeitfenster: At baseline, 3-months, 6 months, 12 months and 24 months.

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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mälardalen University

Mitarbeiter

Uppsala University
Uppsala University Hospital
Uppsala County Council, Sweden
Region Västmanland
Centrallasarettet Västerås

Ermittler

  • Hauptermittler: Petra von Heideken Wågert, Professor, Mälardalen University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2029

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

19. November 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Dezember 2024

Zuerst gepostet (Tatsächlich)

5. Dezember 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2020/1120

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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