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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.

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  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

  Show 54 Study Locations
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 November 20, 2014