NCT06719206

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
57mo left

Started Mar 2025

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Mar 2025Dec 2030

First Submitted

Initial submission to the registry

November 19, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

November 19, 2024

Last Update Submit

January 28, 2026

Conditions

Keywords

sedentary behaviorbehavior changeinterventionRandomized controlled trial

Outcome Measures

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.

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

Secondary Outcomes (10)

  • Sedentary behavior bouts

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

  • 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

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

  • Health-related quality of life

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

  • Cancer related fatigue

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

  • +5 more secondary outcomes

Other Outcomes (8)

  • Demographic variables

    Baseline

  • Diagnoses

    At baseline

  • Cancer treatment

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

  • +5 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants receive a digital support intervention

Behavioral: Digital self-management program

Control

NO INTERVENTION

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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akademiska sjukhuset

Uppsala, Sweden

RECRUITING

Västmanlands sjukhus

Västerås, Sweden

RECRUITING

Related Links

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsProstatic NeoplasmsSedentary Behavior

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Petra von Heideken Wågert, Professor

    Mälardalen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra von Heideken Wågert, Professor

CONTACT

Anna Henriksson

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2024

First Posted

December 5, 2024

Study Start

March 1, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations