CancerPEXONCT04328038
Personalized Exercise Oncology
An observational study of Cancer and Health Behavior, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The Goal of the study is to identify trait-homogenous groups of cancer patients in regards to their physical activity associated health literacy. Based on these Groups, individualized exercise protocols and educative strategies can be developed which may increase the efficacy of the exercise therapy and increases the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Health Behavior
- What is being tested?
- Survey
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- 26 Nov 2018to Feb 2026
- 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: Mixed Cohort of adult cancer patients undergoing treatment Special Subgroup: Multiple Myeloma Patients
Who may be able to join
- Histologically confirmed cancer diagnosis
- Females and males ≥18 years of age
- Undergoing either chemo-, immune-, radio- or anti-hormonal treatment
- Last surgery more than 6 weeks in the past
- Ability to understand English or German
- Be able to provide and understand informed consent
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Score of ≤ 2
Who cannot join
- Heart insufficiency > NYHA III (New York Heart Association) or uncertain arrhythmia
- Uncontrolled hypertension
- Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl)
- Reduced standing or walking
- Current pregnancy
- Any other evidence in the medical record of an absolute contraindication for exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Exercise Oncology (PEXO) - Study
The Goal of the study is to identify trait-homogenous groups of cancer patients in regards to their physical activity associated health literacy. Based on these Groups, individualized exercise protocols and educative strategies can be developed which may increase the efficacy of the exercise therapy and increases the likelihood that patient get involved in physical activity.
- Conditions
- Cancer, Health Behavior
- Being tested
- Survey
- Keywords
- Physical Activity, Exercise, Health literacy, cancer-related symptoms, treatment-related symptoms, personalized Medicine
- Medical subject headings
- Neoplasms, Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Patient fill out a survey containing: Demographic Information, medical history, several Questionnaires about Health Literacy, Well Being/HRQoL and Fatigue
| Study group | Role | What they receive |
|---|---|---|
| USA | Cohort from the USA Receives: Other: Survey | |
| Germany | Cohort from Germany Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Clusters
Identification of different, trait-homogenous patient clusters
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Questionnaire: Physical Activity Associated Health Literacy
To assess physical activity-associated health competence the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used
Measured: through study completion, an average of 1 year
Questionnaire: Health Literacy
To assess health-literacy the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used
Measured: through study completion, an average of 1 year
Questionnaire: Health Related Quality of Life
Quality of Life will be assessed with the validated 30-item self-assessment questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0).
Measured: through study completion, an average of 1 year
Questionnaire: Fatigue
To asses fatigue patients will be asked to complete the 12-item EORTC QLQ-FA12 (FA = fatigue), which is a newly developed questionnaire which has been intensively validated
Measured: through study completion, an average of 1 year
Questionnaire: Physical Activity
Patient's level of physical activity will be assessed with the SQUASH Physical Activity Questionnaire. It includes multiple activities referring to a 'normal' week. Activity dimensions asked include actively commuting physical activity (walking, cycling), physical activity at work or school, household activities, leisure time activities (sports, walking, gardening, cycling).
Measured: through study completion, an average of 1 year
Questionnaire: Emotion Thermometers
Emotion thermometers are four-domain visual-analogue scale including distress, anxiety, depression, and anger. Each domain is rated on an 11-point (0 to 10) Likert scale
Measured: through study completion, an average of 1 year
Questionnaire: Brief Pain Inventory (BPI)
Bone pain will be assessed with the Brief Pain Inventory (BPI). This is a valid and reliable tool for pain measurement in cancer patients with bone metastases. It measures both pain severity and pain interference on function
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start26 Nov 2018
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Joachim Wiskemann, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328038
- Sponsor's protocol ID
- HRP-591-PEXO
- Acronym
- PEXO
- Status last verified
- Jan 2025
- First submitted
- 24 Mar 2020
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greinacher A, Kuehl R, Mai EK, Goldschmidt H, Wiskemann J, Fleischer A, Rasche L, Dapunt U, Maatouk I. The impact of divergent forms of social support on health-related quality of life in patients with multiple myeloma and its precursor states. J Cancer Res Clin Oncol. 2024 Jan 31;150(2):55. doi: 10.1007/s00432-023-05570-9.
PubMed 38291214Kuehl R, Koeppel M, Goldschmidt H, Maatouk I, Rosenberger F, Wiskemann J. Physical activity-related health competence and symptom burden for exercise prescription in patients with multiple myeloma: a latent profile analysis. Ann Hematol. 2023 Nov;102(11):3091-3102. doi: 10.1007/s00277-023-05326-y. Epub 2023 Jun 24.
PubMed 37355476
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Exercise Oncology (PEXO) - Study
- ClinicalTrials.gov ID
- NCT04328038
- Acronym / sponsor ID
- PEXO / HRP-591-PEXO
- Conditions
- Cancer, Health Behavior
- Keywords
- Physical Activity, Exercise, Health literacy, cancer-related symptoms, treatment-related symptoms, personalized Medicine
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Mar 2020 (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.
The Goal of the study is to identify trait-homogenous groups of cancer patients in regards to their physical activity associated health literacy. Based on these Groups, individualized exercise protocols and educative strategies can be developed which may increase the efficacy of the exercise therapy and increases the likelihood that patient get involved in physical activity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| USA | – | Other: SurveyCohort from the USA |
| Germany | – | Other: SurveyCohort from Germany |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mixed Cohort of adult cancer patients undergoing treatment Special Subgroup: Multiple Myeloma Patients
Key inclusion criteria (7 listed)
- Histologically confirmed cancer diagnosis
- Females and males ≥18 years of age
- Undergoing either chemo-, immune-, radio- or anti-hormonal treatment
- Last surgery more than 6 weeks in the past
- Ability to understand English or German
Key exclusion criteria (6 listed)
- Heart insufficiency > NYHA III (New York Heart Association) or uncertain arrhythmia
- Uncontrolled hypertension
- Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl)
- Reduced standing or walking
- Current pregnancy
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 |
|---|---|---|
| SurveyPatient fill out a survey containing: Demographic Information, medical history, several Questionnaires about Health Literacy, Well Being/HRQoL and Fatigue | Other | Germany, USA |
Primary outcome
Patient Clusters
Time frame: through study completion, an average of 1 year
Identification of different, trait-homogenous patient clusters
7 secondary outcomes
Questionnaire: Physical Activity Associated Health Literacy
Time frame: through study completion, an average of 1 year
Questionnaire: Health Literacy
Time frame: through study completion, an average of 1 year
Questionnaire: Health Related Quality of Life
Time frame: through study completion, an average of 1 year
Questionnaire: Fatigue
Time frame: through study completion, an average of 1 year
Questionnaire: Physical Activity
Time frame: through study completion, an average of 1 year
Questionnaire: Emotion Thermometers
Time frame: through study completion, an average of 1 year
Questionnaire: Brief Pain Inventory (BPI)
Time frame: through study completion, an average of 1 year
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 3 Feb 2025.
- Derived from this study: PubMed 38291214Greinacher A, Kuehl R, Mai EK, Goldschmidt H, Wiskemann J, Fleischer A, Rasche L, Dapunt U, Maatouk I. The impact of divergent forms of social support on health-related quality of life in patients with multiple myeloma and its precursor states. J Cancer Res Clin Oncol. 2024 Jan 31;150(2):55. doi: 10.1007/s00432-023-05570-9.
- Derived from this study: PubMed 37355476Kuehl R, Koeppel M, Goldschmidt H, Maatouk I, Rosenberger F, Wiskemann J. Physical activity-related health competence and symptom burden for exercise prescription in patients with multiple myeloma: a latent profile analysis. Ann Hematol. 2023 Nov;102(11):3091-3102. doi: 10.1007/s00277-023-05326-y. Epub 2023 Jun 24.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer and Health Behavior, run by University Hospital Heidelberg 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Clusters (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328038, which also lists 2 linked publications.
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 3 Feb 2025.