Breast Cancer Rehabilitation Program in Improving Quality... | NCT01113554

Studies
Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors

NCT01113554

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

Jul 5, 2018Actual

Enrollment

26Actual

Phase

Not Applicable

Conditions

Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer

Interventions

questionnaire administration
exercise intervention
quality-of-life assessment
survey administration
management of therapy complications
psychosocial assessment and care

Countries

United States

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

ID	Type	Description	Link
NCI-2010-00975
CCCWFU 99309	Other Identifier	Wake Forest University Health Sciences

Status Module

Record Verification Date

Jul 2018

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

Jun 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Apr 28, 2010

First Submission Date that Met QC Criteria

Apr 29, 2010

First Posted Date

Apr 30, 2010Estimated

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

Jul 2, 2018

Last Update Posted Date

Jul 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors.

PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.

Detailed Description

PRIMARY OBJECTIVES:

I. To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program.

II. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP.

SECONDARY OBJECTIVES:

I. To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP.

II. To document the types and the rates of adverse events associated with the BCRP.

OUTLINE:

Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.

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

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm I	Experimental	Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.	Other: questionnaire administration Behavioral: exercise intervention Procedure: quality-of-life assessment Other: survey administration Procedure: management of therapy complications Procedure: psychosocial assessment and care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire administration	Other		Arm I
exercise intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program		Approximately 24 months
BMI		6 months
Muscular strength		6 months
Range of motion		6 months
Quality of life		6 months
Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate		Approximately 24 months
Proportion of women who complete the study and the average number of weeks of participation		Approximately 24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion

First occurrence of breast cancer
BMI >= 25
Recently completed treatment(chemotherapy/radiation) for breast cancer (=< 8 weeks), but can be receiving adjuvant hormonal therapy
Willing to comply with study visits, as outlined in the protocol
Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius
Ability to participate in a moderate exercise program, such as freedom from any orthopedic abnormalities that would prevent participation
Ability to understand and the willingness to sign a written informed consent document

Exclusion

Unstable angina
Cardiac conduction disturbances
Plans to move from the study area
Dementia that is medically documented or suspected
Advanced arterial disease causing ischemia of any limb
Physical immobility
Homebound for medical reasons
Dependent on wheelchair for mobility
Chronic disease which significantly reduces 4-year survival
Recurrent breast cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mara Vitolins	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Health Sciences		Winston-Salem	North Carolina	27157	United States

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D012046	Rehabilitation
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services