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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014