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

December 22, 2010
January 11, 2011
January 2009
June 2010   (final data collection date for primary outcome measure)
Change from Baseline in Fatigue Related Cancer at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]
Piper Fatigue Scale
Same as current
Complete list of historical versions of study NCT01274806 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms
TAKE-CARE: EFFECTIVENESS OF A PHYSICAL THERAPY COMBINING CORE STABILITY EXERCISE AND MASSAGE IN CANCER RELATED SYMPTOMS

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

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Breast Cancer
Other: Physical Therapy
Core Stability Exercise, Endurance training, recovery massage
Other Names:
  • Exercise
  • Relaxation techniques
  • Recovery techniques
  • No Intervention: Usual care
  • Experimental: Physical therapy
    Intervention: Other: Physical Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
December 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

  • Other musculoskeletal conditions.
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01274806
PI0890418, ETES0890418
Yes
Manuel Arroyo Morales, University of Granada
Instituto de Salud Carlos III
Universidad de Granada
Principal Investigator: Manuel Arroyo-Morales, PhD Universidad de Granada
Instituto de Salud Carlos III
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP