NCT06999616

Brief Summary

Background: Physical activity has demonstrated benefits in alleviating side effects and improving well-being in people with cancer. However, activity levels remain low during systemic treatment. Nurses are optimally positioned to lead interventions fostering an activity-friendly culture. Objective: This study aims to evaluate the feasibility and potential effects of the nurse-led, interprofessionally developed physical activity concept OncoMoveNurse in an outpatient oncology setting. Methods: Using a mixed-methods design over 15 months (10/2024-12/2025), the study includes implementation and evaluation phases. Quantitative data (n=50 patients, collected from 06/2025-09/2025) will assess primary (physical activity behavior) and secondary outcomes (self-efficacy, well-being, mood) via validated PROMs. Qualitative insights will be gathered through digital storytelling (n=2 patients, n=2 nurses) and one focus group (n=8 interprofessional team members). Inclusion criteria for patients include age ≥18, cancer diagnosis, at least three treatments in the day clinic, and sufficient German language skills. Intervention: OncoMoveNurse comprises five adaptable components: modular activity structure, safety framework, communication strategy, a team approach, and person-centered orientation. Supporting materials (e.g., posters, videos, exercise tools) and tailored implementation strategies were co-developed in alignment with core values. Analysis: Quantitative data will be analyzed using SPSS (paired t-tests, p\<.05); qualitative data via content analysis in MAXQDA. A mixed-methods synthesis will integrate findings. Ethics \& Data Protection: Patient data collection will commence following ethics approval. All data are anonymized, stored securely, and handled in accordance with Swiss data protection laws. Conclusion: This study will provide insights into the feasibility of nurse-led physical activity promotion in outpatient oncology and inform future outcome evaluations.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Aug 2025Aug 2026

First Submitted

Initial submission to the registry

May 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

December 10, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

May 22, 2025

Last Update Submit

December 3, 2025

Conditions

Keywords

activity promotionsproof-of-conceptimplementationactivity conceptexcercisecancer patientphysical activity

Outcome Measures

Primary Outcomes (1)

  • physical activity behaviour

    Physical activity behavior will be assessed using the "Physical Activity and Sedentary Behavior Assessment Questionnaire" (BSA). The BSA consists of 16 items that capture the duration of physical activity in minutes per day across different intensity levels (light, moderate, vigorous), as well as daily sedentary time. Responses are aggregated and converted into minutes per week. The questionnaire demonstrates good internal consistency with Cronbach's alpha ranging from 0.82 to 0.89, and test-retest reliability of r = 0.76. Construct validity has been confirmed through correlations with accelerometer data (r = 0.68), and discriminant validity has been demonstrated by significant differences between active and inactive groups.

    from enrollment to the end of treatment or three months after enrollment whichever timepoint comes first

Secondary Outcomes (2)

  • Self-efficacy for physical activity

    from enrollment to the end of treatment or three months after enrollment whichever timepoint comes first

  • health-related quality of life

    from enrollment to the end of treatment or three months after enrollment whichever timepoint comes first

Study Arms (1)

patients with cancer in oncology day clinic

patients who receive activity promoting during care at oncology day clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

cancer patients who are treated at oncology day clinic

You may qualify if:

  • diagnosis of cancer,
  • at least three treatments at the oncology outpatient clinic in Münsterlingen during the study period,
  • aged ≥18 years, and
  • sufficient knowledge of German.

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spital Thurgau AG Münsterlingen

Münsterlingen, Switzerland

RECRUITING

MeSH Terms

Conditions

NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Antje Koller, PhD

    Eastern Switzerland University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antje Koller, PhD

CONTACT

Ramona Engst

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 31, 2025

Study Start

August 1, 2025

Primary Completion

March 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

December 10, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

fully anonymized data may be shared if interested researcher ensures proper handling of data

Shared Documents
STUDY PROTOCOL
Time Frame
after study has been finished
Access Criteria
researchers may contact PI for more information

Locations