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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Greifswald, Germany, 17475
        • Recruiting
        • University Medicine Greifswald
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medicine Greifswald

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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