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

This study has been completed.
Sponsor:
Collaborator:
Universidad de Granada
Information provided by:
Instituto de Salud Carlos III
ClinicalTrials.gov Identifier:
NCT01274806
First received: December 22, 2010
Last updated: January 11, 2011
Last verified: January 2009
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Other: Physical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: TAKE-CARE: EFFECTIVENESS OF A PHYSICAL THERAPY COMBINING CORE STABILITY EXERCISE AND MASSAGE IN CANCER RELATED SYMPTOMS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Salud Carlos III:

Primary Outcome Measures:
  • Change from Baseline in Fatigue Related Cancer at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
    Piper Fatigue Scale


Secondary Outcome Measures:
  • Change from Baseline in strength at 6 months [ Time Frame: Baseline, six months ] [ Designated as safety issue: Yes ]
    Leg strength, core muscles strength, arm strength

  • Change from Baseline in Quality of Life at 6 months [ Time Frame: Baseline, six months ] [ Designated as safety issue: Yes ]
    QLQ-Br23

  • Change from Baseline in profile of mood state at 6 months [ Time Frame: Baseline, six months ] [ Designated as safety issue: Yes ]
    Profile of Mood State


Enrollment: 78
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Experimental: Physical therapy Other: Physical Therapy
Core Stability Exercise, Endurance training, recovery massage
Other Names:
  • Exercise
  • Relaxation techniques
  • Recovery techniques

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

  • Other musculoskeletal conditions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274806

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

No publications provided

Responsible Party: Manuel Arroyo Morales, University of Granada
ClinicalTrials.gov Identifier: NCT01274806     History of Changes
Other Study ID Numbers: PI0890418, ETES0890418
Study First Received: December 22, 2010
Last Updated: January 11, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013