Personalized Exercise Oncology
- Conditions
- Health BehaviorCancer
- Interventions
- Other: Survey
- Registration Number
- NCT04328038
- Lead Sponsor
- University Hospital Heidelberg
- Brief 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 likelihood that patient get involved in physical activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Germany Survey Cohort from Germany USA Survey Cohort from the USA
- Primary Outcome Measures
Name Time Method Patient Clusters through study completion, an average of 1 year Identification of different, trait-homogenous patient clusters
- Secondary Outcome Measures
Name Time Method Questionnaire: Health Literacy through study completion, an average of 1 year To assess health-literacy the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used
Questionnaire: Physical Activity Associated Health Literacy through study completion, an average of 1 year To assess physical activity-associated health competence the recently developed and validated questionnaire from Sudeck and Pfeifer (2016) will be used
Questionnaire: Health Related Quality of Life through study completion, an average of 1 year 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).
Questionnaire: Fatigue through study completion, an average of 1 year 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
Questionnaire: Physical Activity through study completion, an average of 1 year 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).
Questionnaire: Brief Pain Inventory (BPI) through study completion, an average of 1 year 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
Questionnaire: Emotion Thermometers through study completion, an average of 1 year 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
Trial Locations
- Locations (1)
Heidelberg University Hospital
🇩🇪Heidelberg, Germany