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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
Instituto de Salud Carlos III
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, physical therapy, massage, core stability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

  • Other musculoskeletal conditions.

Sites / Locations

  • Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Physical therapy

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in Fatigue Related Cancer at 6 months
Piper Fatigue Scale

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2010
Last Updated
January 11, 2011
Sponsor
Instituto de Salud Carlos III
Collaborators
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT01274806
Brief Title
Take-Care Program: Effectiveness of a Physical Therapy Program on Cancer Related Symptoms
Acronym
TAKE-CARE
Official Title
TAKE-CARE: EFFECTIVENESS OF A PHYSICAL THERAPY COMBINING CORE STABILITY EXERCISE AND MASSAGE IN CANCER RELATED SYMPTOMS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto de Salud Carlos III
Collaborators
Universidad de Granada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, physical therapy, massage, core stability

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Physical therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Exercise, Relaxation techniques, Recovery techniques
Intervention Description
Core Stability Exercise, Endurance training, recovery massage
Primary Outcome Measure Information:
Title
Change from Baseline in Fatigue Related Cancer at 6 months
Description
Piper Fatigue Scale
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in strength at 6 months
Description
Leg strength, core muscles strength, arm strength
Time Frame
Baseline, six months
Title
Change from Baseline in Quality of Life at 6 months
Description
QLQ-Br23
Time Frame
Baseline, six months
Title
Change from Baseline in profile of mood state at 6 months
Description
Profile of Mood State
Time Frame
Baseline, six months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Finished oncology treatment (chemotherapy, radiation, surgery) Exclusion Criteria: Other musculoskeletal conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Arroyo-Morales, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Health Sciences
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

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

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