跳至主要内容
临床试验/NCT06999616
NCT06999616招募中不适用

Promoting Physical Activity in Individuals With Cancer in an Oncology Day Clinic - Testing the Feasibility of the Implementation of a Physical Activity Concept Within an Interprofessional Team Led by Nurses OnkoMoveNurse - Proof of Concept

St.Gallen University of Applied Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
physical activity behaviour

研究概览

简要总结

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.

详细描述

Background and Rationale Staying physically active during cancer treatment can help alleviate distressing symptoms such as fatigue, pain, and dyspnoea, and can improve the quality of life of individuals with cancer. Nevertheless, physical activity often decreases during treatment due to various factors, including general physical decline, treatment-related side effects (e.g., nausea, dizziness, muscle weakness), and psychological factors (e.g., anxiety, lack of motivation, depressive symptoms). Other contributing factors may include breathlessness, oxygen deficiency, and reduced physical endurance.

To counteract this, individuals with cancer should be specifically encouraged to engage in physical activity during their outpatient visits-before, during, and after chemotherapy, immunotherapy, or other treatments. The goal is to integrate more physical activity into everyday life.

For this purpose, a dedicated physical activity concept has been developed by a team of experienced professionals. This concept is built around five core components:

  1. A modular exercise catalogue
  2. A safety protocol
  3. A communication strategy
  4. Team orientation
  5. Person-centeredness Further details are available at www.onkomovenurse.net.

________________________________________ Risk / Benefit Assessment

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •pregnancy

结局指标

主要结局

physical activity behaviour

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

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.

次要结局

  • 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)

研究者

发起方
St.Gallen University of Applied Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验