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2022-09-21
2024-12-31
2025-03-31
60
NCT05501379
University Medicine Greifswald
University Medicine Greifswald
OBSERVATIONAL
Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
Physical activity is an important aspect of cancer therapy but correct measurement of physical activity is difficult. In this study, the physical activity of patients undergoing cancer therapy is assessed by questionnaire and by motion tracker. The results are then compared to answer whether there are differences between the two measurements. Findings of this study will help to improve the assessment of physical activity in cancer patients.
Although physical activity has been identified as a relevant determinant of cancer therapy outcome, its valid assessment remains challenging. In principle, direct and indirect assessment instruments can be employed for assessment of physical activity. While direct instruments, e.g. accelerometers, are considered to provide a more objective measurement, indirect tools such as questionnaires are less expensive and more applicable for use in larger study populations. The validity of both forms of measurements in cancer patients is however not well studied. Therefore, this study aims to elucidate the relative validity of an accelerometer in comparison to a standardized physical questionnaire at different time points of cancer therapy. Findings of this study will allow conclusions regarding the ideal modalities for assessment of physical activity in cancer patients.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-08-11 | N/A | 2024-12-23 |
2022-08-11 | N/A | 2024-12-27 |
2022-08-15 | N/A | 2024-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Cancer Patients Patients with a verified diagnosis of lymphoma, colorectal or pancreatic cancer requiring surgical, chemo or radio therapy. | OTHER: No intervention - observational study only
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Comparison of physical activity assessments within 1 week after initiation of cancer therapy | Difference in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Comparison of physical activity assessments 12 weeks after initiation of cancer therapy | Difference in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 12 weeks after initiation of cancer therapy |
| Comparison of changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy | Difference in changes of physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 12 weeks after initiation of cancer therapy |
| Physical activity assessed by accelerometer | Physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Physical activity assessed by questionnaire | Physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by accelerometer | Association between ECOG Performance Status and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by questionnaire | Association between ECOG Performance Status and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of Karnofsky Performance Status (KPS) to physical activity assessed by accelerometer | Association between KPS and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of Karnofsky Performance Status (KPS) to physical activity assessed by questionnaire | Association between KPS and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of age to physical activity assessed by accelerometer | Association between age and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy |
| Relation of age to physical activity assessed by questionnaire | Association between age and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy |
| Relation of sex to physical activity assessed by accelerometer | Association between sex and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy |
| Relation of sex to physical activity assessed by questionnaire | Association between sex and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy |
| Relation of quality of life to physical activity assessed by accelerometer | Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of quality of life to physical activity assessed by questionnaire | Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Therapy-related quality of life | Association between quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) and cancer therapy modality | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of fatigue to physical activity assessed by accelerometer | Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of fatigue to physical activity assessed by questionnaire | Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Therapy-related fatigue | Association between fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) and cancer therapy modality | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of sleep duration to physical activity assessed by accelerometer | Association between sleep duration measured by the GeneActiv accelerometer in hours and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of sleep duration to physical activity assessed by questionnaire | Association between sleep duration measured by the GeneActiv accelerometer in hours and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of sleep efficiency to physical activity assessed by accelerometer | Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs) | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Relation of sleep efficiency to physical activity assessed by questionnaire | Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and physical activity measured by the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Therapy-related sleep duration | Association between sleep duration measured by the GeneActiv accelerometer in hours and cancer therapy modality | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Therapy-related sleep efficiency | Association between sleep efficiency, i.e. the ratio of sleep duration to total bed time measured by the GeneActiv accelerometer in hours, and cancer therapy modality | 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy |
| Changes in fatigue between assessements before and 12 weeks after initiation of cancer therapy | Differences in fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12) | 12 weeks after initiation of cancer therapy |
| Changes in quality of life between assessements before and 12 weeks after initiation of cancer therapy | Differences in quality of life assessed by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ C-30) | 12 weeks after initiation of cancer therapy |
| Relation of tumor entity to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy | Association between tumor entity and changes in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 12 weeks after initiation of cancer therapy |
| Relation of cancer therapy modality to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy | Association between cancer therapy modality and changes in physical activity measured by the GeneActiv accelerometer and the short version of the International Physical Activity Questionnaire (IPAQ-sf) in metabolic equivalents of tasks (METs) | 12 weeks after initiation of cancer therapy |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Ali A Aghdassi, Professor Phone Number: +493834867230 Email: ali.aghdassi@med.uni-greifswald.de |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
