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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05501379

Studienbeginn:
September 2022

Letztes Update:
16.11.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Pancreatic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Medicine Greifswald

Collaborator:
-

Studienleiter

Ali A Aghdassi, Professor
Principal Investigator
University Medicine Greifswald

Kontakt

Ali A Aghdassi, Professor
Kontakt:
Phone: +493834867230
E-Mail: ali.aghdassi@med.uni-greifswald.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Medicine Greifswald
17475 Greifswald
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ali A Aghdassi, Professor
Phone: +493834867230
E-Mail: ali.aghdassi@med.uni-greifswald.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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)

Secondary outcome:

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

6. 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)

7. 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)

8. 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)

9. 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)

10. 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)

11. 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)

12. 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)

13. 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)

14. 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)

15. 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

16. 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)

17. 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)

18. 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

19. 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)

20. 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)

21. 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)

22. 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)

23. 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

24. 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

25. 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)

26. 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)

27. 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)

28. 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)

Geprüfte Regime

No intervention - observational study only:
No intervention - observational study only

Quelle: ClinicalTrials.gov

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