Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Physical Therapy

• Registration Number: NCT01274806
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2011-01-11
• Last Update Submitted: 2011-01-11
• Study First Posted: 2011-01-12
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 78

Inclusion Criteria

• Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria

• Other musculoskeletal conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical therapy	Physical Therapy	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Fatigue Related Cancer at 6 months	Baseline, 6 months	Piper Fatigue Scale

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in strength at 6 months	Baseline, six months	Leg strength, core muscles strength, arm strength
Change from Baseline in Quality of Life at 6 months	Baseline, six months	QLQ-Br23
Change from Baseline in profile of mood state at 6 months	Baseline, six months	Profile of Mood State

Trial Locations

Locations (1)

Faculty of Health Sciences; 🇪🇸 Granada, Spain