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

January 11, 2011 updated by: Instituto de Salud Carlos III

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

  • Other musculoskeletal conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: Physical therapy
Other: Physical Therapy
Core Stability Exercise, Endurance training, recovery massage
Other Names:
  • Exercise
  • Relaxation techniques
  • Recovery techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Fatigue Related Cancer at 6 months
Time Frame: Baseline, 6 months
Piper Fatigue Scale
Baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in strength at 6 months
Time Frame: Baseline, six months
Leg strength, core muscles strength, arm strength
Baseline, six months
Change from Baseline in Quality of Life at 6 months
Time Frame: Baseline, six months
QLQ-Br23
Baseline, six months
Change from Baseline in profile of mood state at 6 months
Time Frame: Baseline, six months
Profile of Mood State
Baseline, six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Salud Carlos III

Collaborators

Universidad de Granada

Investigators

  • Principal Investigator: Manuel Arroyo-Morales, PhD, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 22, 2010

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

January 12, 2011

Last Update Submitted That Met QC Criteria

January 11, 2011

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI0890418
  • ETES0890418 (Other Grant/Funding Number: ETES0890418)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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