- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576107
MOTIVACTION - Study
April 22, 2014 updated by: German Cancer Research Center
Motivational Intervention Enhancing Physical Activity In Oncology Patients (MOTIVACTION)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Heidelberg, Baden-Württemberg, Germany, 69120
- National Center for Tumor Diseases (German Cancer Research Center)
-
Heidelberg, Baden-Württemberg, Germany, 69120
- National Center for Tumor Diseases
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physical activity
Exercise counseling (behavior change techniques)
|
4-week exercise intervention for cancer patients of different entities and out-patient regimes.
|
Experimental: Stress-management
Stress-management training
|
4-week stress-management-training for cancer patients of different entities and out-patient regimes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity (accelerometer, Actigraph)
Time Frame: 4 weeks
|
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)
Time Frame: 4 weeks, 3 months
|
Wendel-Vos, G.C.W. et al., 2003
|
4 weeks, 3 months
|
Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)
Time Frame: 4 weeks, 3 months
|
German version by Freud, T. (2011)
|
4 weeks, 3 months
|
Quality of life (EORTC QLQ C30)
Time Frame: 4 weeks, 3 months
|
Aaronson, N. K. et al. (1993)
|
4 weeks, 3 months
|
variables of the Health Action Process Approach
Time Frame: 4 weeks, 3 months
|
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
Time Frame: 4 weeks, 3 months
|
adapted from Krämer&Fuchs (2010), developed in pilot studies
|
4 weeks, 3 months
|
Exercise experience
Time Frame: 4 weeks, 3 Months
|
questionnaire adapted from Fuchs, R., 2009
|
4 weeks, 3 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joachim Wiskemann, Dr., German Cancer Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
April 5, 2012
First Submitted That Met QC Criteria
April 10, 2012
First Posted (Estimate)
April 12, 2012
Study Record Updates
Last Update Posted (Estimate)
April 23, 2014
Last Update Submitted That Met QC Criteria
April 22, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NCT-PA8
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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