Clinical trial NCT05501379: Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
Official title: Comparison of the Physical Activity Assessed by an Accelerometer and the International Physical Activity Questionnaire in Oncologic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphoma
Pancreas Cancer
Colorectal Cancer
Keywords: Physical Activity
Accelerometer
International Physical Activity Questionnaire
Cancer Therapy
GeneActiv
Quality of Life
Fatigue
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of physical activity assessments within 1 week after initiation of cancer therapy
timeFrame: 1 week after initiation of cancer therapy
Secondary outcomes:
measure: Comparison of physical activity assessments 12 weeks after initiation of cancer therapy
timeFrame: 12 weeks after initiation of cancer therapy
measure: Comparison of changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy
timeFrame: 12 weeks after initiation of cancer therapy
measure: Physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Physical activity assessed by questionnaire
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of Eastern Co-operative Oncology Group (ECOG) Performance Status to physical activity assessed by questionnaire
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of Karnofsky Performance Status (KPS) to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of Karnofsky Performance Status (KPS) to physical activity assessed by questionnaire
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of age to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy
measure: Relation of age to physical activity assessed by questionnaire
timeFrame: 1 week after initiation of cancer therapy
measure: Relation of sex to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy
measure: Relation of sex to physical activity assessed by questionnaire
timeFrame: 1 week after initiation of cancer therapy
measure: Relation of quality of life to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of quality of life to physical activity assessed by questionnaire
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Therapy-related quality of life
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of fatigue to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of fatigue to physical activity assessed by questionnaire
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Therapy-related fatigue
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of sleep duration to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of sleep duration to physical activity assessed by questionnaire
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of sleep efficiency to physical activity assessed by accelerometer
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Relation of sleep efficiency to physical activity assessed by questionnaire
timeFrame: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Therapy-related sleep duration
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Therapy-related sleep efficiency
timeFrame: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
measure: Changes in fatigue between assessements before and 12 weeks after initiation of cancer therapy
timeFrame: 12 weeks after initiation of cancer therapy
measure: Changes in quality of life between assessements before and 12 weeks after initiation of cancer therapy
timeFrame: 12 weeks after initiation of cancer therapy
measure: Relation of tumor entity to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy
timeFrame: 12 weeks after initiation of cancer therapy
measure: Relation of cancer therapy modality to changes in physical activity between assessements within 1 week and 12 weeks after initiation of cancer therapy
timeFrame: 12 weeks after initiation of cancer therapy
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Ali A Aghdassi, Professor
role: PRINCIPAL_INVESTIGATOR
References: