LymphomaOncoPhysNCT05501379
Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
An observational study of Lymphoma and Pancreas Cancer, run by University Medicine Greifswald at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Pancreas Cancer, Colorectal Cancer
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 21 Sep 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- verified diagnosis of lymphoma, colorectal or pancreatic cancer
- requirement of surgical, chemo or radio therapy
- provision of informed consent
Who cannot join
- pregnancy
- inability to provide consent
- use of a rollator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medicine Greifswald
Greifswald, 17475
Ali A Aghdassi, Professor, +493834867230, ali.aghdassi@med.uni-greifswald.de
Ali A Aghdassi, Professor
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphoma, Pancreas Cancer, Colorectal Cancer
- Being tested
- No intervention - observational study only
- Keywords
- Physical Activity, Accelerometer, International Physical Activity Questionnaire, Cancer Therapy, GeneActiv, Quality of Life, Fatigue
- Medical subject headings
- Lymphoma, Pancreatic Neoplasms, Colorectal Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational study onlyOther
No intervention - observational study only
| Study group | Role | What they receive |
|---|---|---|
| Cancer Patients | Patients with a verified diagnosis of lymphoma, colorectal or pancreatic cancer requiring surgical, chemo or radio therapy. Receives: Other: No intervention - observational study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 week after initiation of cancer therapy
Secondary outcomes (28)
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)
Measured: 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
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)
Measured: 12 weeks after initiation of cancer therapy
Physical activity assessed by accelerometer
Physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)
Measured: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
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)
Measured: 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
Association between ECOG Performance Status and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)
Measured: 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
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)
Measured: 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
Association between KPS and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)
Measured: 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
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)
Measured: 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
Association between age and physical activity measured by the GeneActiv accelerometer in metabolic equivalents of tasks (METs)
Measured: 1 week after initiation of cancer therapy
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)
Measured: 1 week after initiation of cancer therapy
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)
Measured: 1 week after initiation of cancer therapy
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)
Measured: 1 week after initiation of cancer therapy
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)
Measured: 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
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)
Measured: 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
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
Measured: 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
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)
Measured: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
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)
Measured: 1 week before initiation of cancer therapy, 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
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
Measured: 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
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)
Measured: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
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)
Measured: 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
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)
Measured: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
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)
Measured: 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
Association between sleep duration measured by the GeneActiv accelerometer in hours and cancer therapy modality
Measured: 1 week after initiation of cancer therapy, 12 weeks after initiation of cancer therapy
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
Measured: 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
Differences in fatigue assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire (EORTC QLQFA-12)
Measured: 12 weeks after initiation of cancer therapy
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)
Measured: 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
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)
Measured: 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
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)
Measured: 12 weeks after initiation of cancer therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start21 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali A Aghdassi, Professor, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501379
- Sponsor's protocol ID
- BB 067/22
- Acronym
- OncoPhys
- Status last verified
- Dec 2024
- First submitted
- 11 Aug 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Physical Activity Assessed by an Accelerometer and the International Physical Activity Questionnaire in Oncologic Patients
- ClinicalTrials.gov ID
- NCT05501379
- Acronym / sponsor ID
- OncoPhys / BB 067/22
- Conditions
- Lymphoma, Pancreas Cancer, Colorectal Cancer
- Keywords
- Physical Activity, Accelerometer, International Physical Activity Questionnaire, Cancer Therapy, GeneActiv, Quality of Life, Fatigue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients | – | Other: No intervention - observational study onlyPatients with a verified diagnosis of lymphoma, colorectal or pancreatic cancer requiring surgical, chemo or radio therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- verified diagnosis of lymphoma, colorectal or pancreatic cancer
- requirement of surgical, chemo or radio therapy
- provision of informed consent
Key exclusion criteria (3 listed)
- pregnancy
- inability to provide consent
- use of a rollator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - observational study onlyNo intervention - observational study only | Other | Cancer Patients |
Primary outcome
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)
28 secondary outcomes
Comparison of physical activity assessments 12 weeks after initiation of cancer therapy
Time frame: 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
Physical activity assessed by accelerometer
Time frame: 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
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
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
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
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
Relation of age to physical activity assessed by accelerometer
Time frame: 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
Relation of sex to physical activity assessed by accelerometer
Time frame: 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
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
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
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
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
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
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
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
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
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
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
Therapy-related sleep duration
Time frame: 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
Changes in fatigue between assessements before and 12 weeks after initiation of cancer therapy
Time frame: 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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali A Aghdassi, Professor principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Pancreas Cancer, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali A Aghdassi, Professor (+493834867230, ali.aghdassi@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of physical activity assessments within 1 week after initiation of cancer therapy (time frame: 1 week after initiation of cancer therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.