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

Sponsor
University Medicine Greifswald (Other)
Overall Status
Recruiting
CT.gov ID
NCT05501379
Collaborator
(none)
60
1
26
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention - observational study only

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Comparison of the Physical Activity Assessed by an Accelerometer and the International Physical Activity Questionnaire in Oncologic Patients
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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
No intervention - observational study only

Outcome Measures

Primary Outcome Measures

  1. Comparison of physical activity assessments within 1 week after initiation of cancer therapy [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 Measures

  1. Comparison of physical activity assessments 12 weeks after initiation of cancer therapy [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medicine Greifswald Greifswald Germany 17475

Sponsors and Collaborators

  • University Medicine Greifswald

Investigators

  • Principal Investigator: Ali A Aghdassi, Professor, University Medicine Greifswald

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT05501379
Other Study ID Numbers:
  • BB 067/22
First Posted:
Aug 15, 2022
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Medicine Greifswald
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022