Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms (TAKE-CARE)
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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 |
- Change from Baseline in Fatigue Related Cancer at 6 months [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: Yes ]Piper Fatigue Scale
- 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:
|
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 |
Inclusion Criteria:
- Finished oncology treatment (chemotherapy, radiation, surgery)
Exclusion Criteria:
- Other musculoskeletal conditions.
Contacts and Locations| Spain | |
| Faculty of Health Sciences | |
| Granada, Spain, 18071 | |
| 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 October 18, 2012
