Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms (TAKE-CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01274806
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : January 12, 2011
Universidad de Granada
Information provided by:
Instituto de Salud Carlos III

Brief Summary:
Effectiveness of a physical therapy program focussed on core stability exercise and massage as a recovery method in breast cancer survivors after oncology treatment.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Physical Therapy Not Applicable

Detailed Description:

Eligibility Criteria

1, had a diagnosis of breast cancer (stage I-IIIA); 2, between 25-65 years; 3, finished co-adjuvant treatment except hormone-therapy; 4, not having active cancer; 5, interest to improve their lifestyle increasing physical activity; and, 6, present 3 to 5 of the following physical findings, judged by the oncologist who referred the patient: neck or shoulder pain symptoms, reduced range of motion in neck- shoulder area, reduced physical capacity, any psychological problem, increased fatigue, sleep disturbances, or any problem in coping with reduced physical and psychosocial functioning.

Principal Outcomes Fatigue Score: Piper Fatigue Scale Mood State:Profile of Mood State Quality of Life: QLQ-BR23

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : January 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Usual care
Experimental: Physical therapy Other: Physical Therapy
Core Stability Exercise, Endurance training, recovery massage
Other Names:
  • Exercise
  • Relaxation techniques
  • Recovery techniques

Primary Outcome Measures :
  1. Change from Baseline in Fatigue Related Cancer at 6 months [ Time Frame: Baseline, 6 months ]
    Piper Fatigue Scale

Secondary Outcome Measures :
  1. Change from Baseline in strength at 6 months [ Time Frame: Baseline, six months ]
    Leg strength, core muscles strength, arm strength

  2. Change from Baseline in Quality of Life at 6 months [ Time Frame: Baseline, six months ]

  3. Change from Baseline in profile of mood state at 6 months [ Time Frame: Baseline, six months ]
    Profile of Mood State

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

  • Other musculoskeletal conditions.

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 identifier (NCT number): NCT01274806

Faculty of Health Sciences
Granada, Spain, 18071
Sponsors and Collaborators
Instituto de Salud Carlos III
Universidad de Granada
Principal Investigator: Manuel Arroyo-Morales, PhD Universidad de Granada

Responsible Party: Manuel Arroyo Morales, University of Granada Identifier: NCT01274806     History of Changes
Other Study ID Numbers: PI0890418
ETES0890418 ( Other Grant/Funding Number: ETES0890418 )
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2009

Keywords provided by Instituto de Salud Carlos III:
breast cancer
physical therapy
core stability