MOTIVACTION - Study

Study Overview
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Brief Summary
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Impact of a 4-week exercise intervention vs. a stress-management-training on physical activity (measured objectively and by questionnaire) of cancer patients of different entities and out-patient regimes.

Official Title
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Motivational Intervention Enhancing Physical Activity In Oncology Patients (MOTIVACTION)

Conditions
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Cancer

Intervention / Treatment
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* Other: Exercise counseling (behavior change techniques)
* Other: Stress-management training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physical activity < 150 minutes /week Patients are currently receiving outpatient treatment (acute or maintenance therapy) or finished this therapy not longer than six months ago Exclusion Criteria: Serious Orthopedic limitations Serious neurological disorders Serious cardiovascular diseases Bone metastases wound healing / scarring not completed Rehabilitation during the next eight weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>Exercise counseling (behavior change techniques) | Other: Exercise counseling (behavior change techniques)<br>* 4-week exercise intervention for cancer patients of different entities and out-patient regimes.<br>|
| Experimental: Stress-management<br>Stress-management training | Other: Stress-management training<br>* 4-week stress-management-training for cancer patients of different entities and out-patient regimes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity (accelerometer, Actigraph) | measured for 7 days | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity (Short QUestionnaire to ASsess Healthenhancing physical activity, SQUASH) | Wendel-Vos, G.C.W. et al., 2003 | 4 weeks, 3 months | 
| Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G) | German version by Freud, T. (2011) | 4 weeks, 3 months | 
| Quality of life (EORTC QLQ C30) | Aaronson, N. K. et al. (1993) | 4 weeks, 3 months | 
| variables of the Health Action Process Approach | scales are developed according to the guidelines by the founder of the theory (Schwarzer, 2008) | 4 weeks, 3 months | 
| Barriers and barrier management in physical exercise | adapted from Krämer&Fuchs (2010), developed in pilot studies | 4 weeks, 3 months | 
| Exercise experience | questionnaire adapted from Fuchs, R., 2009 | 4 weeks, 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Different cancer entities