- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05501379
Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker (OncoPhys)
December 23, 2024 updated by: University Medicine Greifswald
Comparison of the Physical Activity Assessed by an Accelerometer and the International Physical Activity Questionnaire in Oncologic Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
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
Study Locations
-
-
-
Greifswald, Germany, 17475
- Recruiting
- University Medicine Greifswald
-
Contact:
- Ali A Aghdassi, Professor
- Phone Number: +493834867230
- Email: ali.aghdassi@med.uni-greifswald.de
-
Principal Investigator:
- Ali A Aghdassi, Professor
-
Sub-Investigator:
- Mats L Wiese, MSc
-
Sub-Investigator:
- Sebastian Schmidt
-
-
Participation Criteria
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited at University Medicine Greifswald (Northeast Germany).
Patients with the verified diagnosis of lymphoma, colerectal or pancreatic cancer requiring surgical, chemo or radio therapy will be identified in the respective wards or day care units of the hosptial.
Description
Inclusion Criteria:
- verified diagnosis of lymphoma, colorectal or pancreatic cancer
- requirement of surgical, chemo or radio therapy
- provision of informed consent
Exclusion Criteria:
- pregnancy
- inability to provide consent
- use of a rollator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cancer Patients
Patients with a verified diagnosis of lymphoma, colorectal or pancreatic cancer requiring surgical, chemo or radio therapy.
|
No intervention - observational study only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of physical activity assessments within 1 week after initiation of cancer therapy
Time Frame: 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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of physical activity assessments 12 weeks after initiation of cancer therapy
Time Frame: 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
Time Frame: 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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali A Aghdassi, Professor, University Medicine Greifswald
Study record dates
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 Major Dates
Study Start (Actual)
September 21, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
March 31, 2025
Study Registration Dates
First Submitted
August 11, 2022
First Submitted That Met QC Criteria
August 11, 2022
First Posted (Actual)
August 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 23, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB 067/22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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