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MOTIVACTION - Study

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ClinicalTrials.gov Identifier: NCT01576107
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : April 23, 2014
Sponsor:
Collaborator:
Heidelberg University
Information provided by (Responsible Party):
German Cancer Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Other: Exercise counseling (behavior change techniques) Other: Stress-management training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Motivational Intervention Enhancing Physical Activity In Oncology Patients (MOTIVACTION)
Study Start Date : April 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Physical activity
Exercise counseling (behavior change techniques)
Other: 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
Other: Stress-management training
4-week stress-management-training for cancer patients of different entities and out-patient regimes.



Primary Outcome Measures :
  1. Physical activity (accelerometer, Actigraph) [ Time Frame: 4 weeks ]
    measured for 7 days


Secondary Outcome Measures :
  1. physical activity (Short QUestionnaire to ASsess Healthenhancing physical activity, SQUASH) [ Time Frame: 4 weeks, 3 months ]
    Wendel-Vos, G.C.W. et al., 2003

  2. Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G) [ Time Frame: 4 weeks, 3 months ]
    German version by Freud, T. (2011)

  3. Quality of life (EORTC QLQ C30) [ Time Frame: 4 weeks, 3 months ]
    Aaronson, N. K. et al. (1993)

  4. 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)

  5. Barriers and barrier management in physical exercise [ Time Frame: 4 weeks, 3 months ]
    adapted from Krämer&Fuchs (2010), developed in pilot studies

  6. Exercise experience [ Time Frame: 4 weeks, 3 Months ]
    questionnaire adapted from Fuchs, R., 2009



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576107


Locations
Germany
National Center for Tumor Diseases (German Cancer Research Center)
Heidelberg, Baden-Württemberg, Germany, 69120
National Center for Tumor Diseases
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
German Cancer Research Center
Heidelberg University
Investigators
Principal Investigator: Joachim Wiskemann, Dr. German Cancer Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT01576107     History of Changes
Other Study ID Numbers: NCT-PA8
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by German Cancer Research Center:
Different cancer entities