Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer (Y&S)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01647607
First received: July 19, 2012
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to address gaps in care of young women with breast cancer by determining whether educational interventions focusing on issues unique to young women with breast cancer and healthy lifestyles for women with breast cancer help to improve care of young breast cancer patients. The investigators believe that if addressed early in a young woman's care, concerns related to fertility, body image, sexual dysfunction, and physical activity will improve the satisfaction with care and quality of life of this vulnerable population. The research will be conducted by exporting refined, previously piloted educational interventions to 14 academic sites and 40 community medical clinics. The investigators will compare how interaction with each intervention affects patients' quality of life and satisfaction with quality of care.


Condition Intervention
Breast Cancer
Behavioral: Young Women's Intervention (YWI)
Behavioral: Physical Activity Intervention (PAI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Comparison of attention rates in the YWI and the PAI [ Time Frame: 3 Months Post-Enrollment ] [ Designated as safety issue: No ]
    The YWI and PAI arms will be compared in terms of the attention rate at 3 months using generalized estimated equations (GEEs) to account for clustered binary data. Comparison will be based on testing the term for treatment arm.


Secondary Outcome Measures:
  • The effect of the YWI on quality of care measures [ Time Frame: 3, 6, and 12 Months Post-Enrollment ] [ Designated as safety issue: No ]
    To describe the effect of the YWI on other important quality of care measures (attention to genetic issues and attention to emotional health), we will estimate proportions for each arm and report 95% Confidence Intervals (CIs), evaluating the measures separately.

  • Effect of the PAI on improvement of exercise behaviors [ Time Frame: 3 Months Post-Enrollment ] [ Designated as safety issue: No ]
    To examine the effects of the PAI on improvement of exercise behaviors, the mean change in MVPA at 3 months (post - pre) will be evaluated in each of the arms. Estimates of mean change and 95% CIs will be determined using GEEs accounting for a stratum effect and clustering within practice.

  • Effects of the PAI on changes in physical activity based on MVA at three months [ Time Frame: 3 Months Post-Enrollment ] [ Designated as safety issue: No ]
    To examine the effects of the PAI on change in exercise behaviors based on other measures of physical activity, the mean change in MVA at 3 months and the change in LSI at 3 months will be evaluated in each of the arms. Change at 3 months is change from recalled pre-intervention to 3 months (post - pre). Estimates of mean change and 95% CIs will be determined using GEEs accounting for a stratum effect and clustering within practice.

  • Relationship between attention rate and quality of care within each arm (YWI and PAI) [ Time Frame: 3 Months Post-Enrollment ] [ Designated as safety issue: No ]
    To describe the relationship of the attention rate at 3 months with other quality of care measures at 3 months, the quality of care measures will be dichotomized by the median or an established cutoff (high score vs. low score) and the attention rate within each group will be estimated with 95% CIs, accounting for clustering within practice and not for stratification. Quality of care measures will be evaluated separately and relationships will be described for each arm separately.

  • Effect of demographics on the YWI [ Time Frame: 3, 6, and 12 Months Post-Enrollment ] [ Designated as safety issue: No ]
    To further describe the YWI treatment effect, exploratory analyses may include adjustment for patient demographics and, if appropriate, including variables in the secondary analyses as well as practice-level characteristics such as setting (urban, suburban, rural) and size of practice.

  • Effect of the YWI on maintenance of the attention rate [ Time Frame: 6 Months Post-Enrollment ] [ Designated as safety issue: No ]
    To examine the effects of the YWI on maintenance of the attention rate, we will determine the attention rate at 6 months and 95% CI. There will be separate estimates for each arm.

  • Effect of the PAI on maintenance of exercise behaviors [ Time Frame: 6 and 12 Months Post-Enrollment ] [ Designated as safety issue: No ]
    To examine the effects of the PAI on maintenance of exercise behaviors, the arms will be evaluated in terms of mean change in MVPA at 6 and 12 months (post - pre). Time points will be evaluated separately. Descriptive analyses will use GEE models similar to those evaluating change at 3 months.


Estimated Enrollment: 610
Study Start Date: June 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Young Women's Intervention (YWI)
This arm involves administration of an educational intervention that focuses on issues unique to young women with breast cancer, including career development, starting/raising a family, body image, and genetic predispositions to breast cancer.
Behavioral: Young Women's Intervention (YWI)
This educational intervention uses print and web-based materials to focus on issues unique to young women with breast cancer, including career development, starting/raising a family, body image, and genetic predispositions to breast cancer.
Active Comparator: Physical Activity Intervention (PAI)
This arm involves administration of an educational intervention that focuses on developing and/or maintaining a healthy lifestyle for young women with breast cancer, including the benefits of exercise and resources to enhance physical activity after diagnosis.
Behavioral: Physical Activity Intervention (PAI)
This educational intervention uses print and web-based materials that focus on developing and/or maintaining a healthy lifestyle for young women with breast cancer, including the benefits of exercise and resources to enhance physical activity after diagnosis.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female age 18-45 years at diagnosis
  • Within 3 months of stage I-III invasive breast cancer diagnosis
  • No known recurrence of breast cancer or metastatic breast cancer
  • Able to read and write in English
  • Has first appointment with medical oncologist after the provider's practice is enrolled in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647607

  Hide Study Locations
Locations
United States, California
Santa Monica Hematology-Oncology Consultants
Santa Monica, California, United States, 90404
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
Penrose St. Francis Health Services
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, Florida
Cancer Center of South Florida
Palm Beach Gardens, Florida, United States, 33410
Space Coast Cancer Center
Titusville, Florida, United States, 32796
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342
United States, Idaho
St. Luke's Mountain States Tumor Institute
Boise, Idaho, United States, 83712
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Presence Resurrection Medical Center
Chicago, Illinois, United States, 60631
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Edward Hospital
Naperville, Illinois, United States, 60540
Oncology Specialists Research Institute
Niles, Illinois, United States, 60714
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Kansas
Overland Park Regional Medical Center
Overland Park, Kansas, United States, 66209
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
United States, Louisiana
Christus St. Frances Cabrini Hospital
Alexandria, Louisiana, United States, 71301
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
United States, Maine
MaineGeneral Medical Center
Augusta, Maine, United States, 04330
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
Center for Breast Health
Bethesda, Maryland, United States, 20817
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14203
Hematology Oncology Associates of Central New York
East Syracuse, New York, United States, 13057
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
Columbia University Medical Center
New York, New York, United States, 10032
South Shore Hematology Oncology
Valley Stream, New York, United States, 11580
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Oncology Specialists of Charlotte
Charlotte, North Carolina, United States, 28207
Duke Cancer Network
Durham, North Carolina, United States, 27707
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
Ohio State University
Columbus, Ohio, United States, 43212
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Lehigh Valley Hospital and Health Network
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
United States, Tennessee
Cookeville Regional Medical Center
Cookeville, Tennessee, United States, 38501
West Clinic
Memphis, Tennessee, United States, 38120
Vanderbilt University
Nashville, Tennessee, United States, 37204
United States, Texas
Baptist Hospital of Southeast Texas
Beaumont, Texas, United States, 77701
Texas Oncology- Round Rock
Round Rock, Texas, United States, 78681
United States, Virginia
Shenandoah Oncology
Winchester, Virginia, United States, 22601
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
Fox Valley Hematology and Oncology
Appleton, Wisconsin, United States, 54911
Gundersen Clinic, Ltd.
LaCrosse, Wisconsin, United States, 54601
Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Dana-Farber Cancer Institute
American Society of Clinical Oncology
Investigators
Principal Investigator: Ann H Partridge, MD, MPH Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01647607     History of Changes
Other Study ID Numbers: DFCI 12-101
Study First Received: July 19, 2012
Last Updated: August 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Breast Cancer
Young Women
Fertility
Physical Activity
Survivorship

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014