Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker

Colorectal Cancer Clinical Trial

— OncoPhys  

Official title:

Comparison of the Physical Activity Assessed by an Accelerometer and the International Physical Activity Questionnaire in Oncologic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05501379
• Other study ID #: BB 067/22
• Status: Recruiting
• Start date: September 21, 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: University Medicine Greifswald
• Contact: Ali A Aghdassi, Professor
• Phone: +493834867230
• Email: ali.aghdassi[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Lymphoma
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• No intervention - observational study only
No intervention - observational study only

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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