Take-Care Program: Effectiveness of a Physical Therapy Pr... | NCT01274806

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

NCT01274806

Sponsor

Instituto de Salud Carlos III

Status

Completed

Last Update Posted

Jan 12, 2011Estimated

Enrollment

78Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Physical Therapy

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ETES0890418	Other Grant/Funding Number	ETES0890418

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Dec 22, 2010

First Submission Date that Met QC Criteria

Jan 11, 2011

First Posted Date

Jan 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2011

Last Update Posted Date

Jan 12, 2011Estimated

Name	Class
Universidad de Granada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usual care	No Intervention
Physical therapy	Experimental		Other: Physical Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical Therapy	Other	Core Stability Exercise, Endurance training, recovery massage	Physical therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in strength at 6 months	Leg strength, core muscles strength, arm strength	Baseline, six months
Change from Baseline in Quality of Life at 6 months	QLQ-Br23

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Finished oncology treatment (chemotherapy, radiation, surgery)

Exclusion Criteria:

Other musculoskeletal conditions.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel Arroyo-Morales, PhD	Universidad de Granada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Health Sciences		Granada	Granada	18071	Spain

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities
D015444	Exercise
D012064	Relaxation Therapy
D000096063	Post-Exercise Recovery Techniques

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation
D009043	Motor Activity
D009068	Movement

Browse Leaves

Not provided

Browse Branches

Not provided