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:
Dana-Farber Cancer Institute
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: July 11, 2016
Last verified: July 2016
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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: | August 2020 |
| Primary Completion Date: | August 2015 (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 (Adult) |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647607
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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, Florida | |
| Cancer Center of South Florida | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| Northside Hospital Cancer Center | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Presence Resurrection Medical Center | |
| Chicago, Illinois, United States, 60631 | |
| 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 | |
| Norton Cancer Institute | |
| Louisville, Kentucky, United States, 40202 | |
| Baptist Hospital East | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Louisiana | |
| Mary Bird Perkins Cancer Center | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48104 | |
| United States, Montana | |
| Billings Clinic | |
| Billings, Montana, United States, 59101 | |
| United States, New York | |
| Northern Westchester Hospital | |
| Mount Kisco, New York, United States, 10549 | |
| 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 | |
| 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 | |
| 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 | |
| United States, Texas | |
| 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 | |
| Gundersen Clinic, Ltd. | |
| LaCrosse, Wisconsin, United States, 54601 | |
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
Publications:
| 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: | July 11, 2016 |
| 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on September 26, 2016