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

  • Germany
    • 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)
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.

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

German Cancer Research Center

Collaborators

Heidelberg University

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.

General Publications

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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