|First Submitted Date ICMJE||July 19, 2012|
|First Posted Date ICMJE||July 23, 2012|
|Last Update Posted Date||May 15, 2017|
|Start Date ICMJE||June 2012|
|Primary Completion Date||August 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Comparison of attention rates in the YWI and the PAI [ Time Frame: 3 Months Post-Enrollment ]
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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01647607 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer|
|Official Title ICMJE||Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer|
|Brief Summary||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.|
Breast cancer in young women is a not a common disease, yet over 12,000 women under 40 are diagnosed with invasive breast cancer yearly in the United States alone and an additional 2000 are diagnosed with noninvasive disease. Furthermore, when young women are diagnosed with breast cancer, the burden of the disease and treatment on this population is great. Breast cancer is the leading cause of cancer-related deaths in women under 40, and survival rates for young women with breast cancer are lower than for their older counterparts (21,22).
In addition to being at higher risk of dying from breast cancer, and therefore usually receiving more aggressive therapy, young women are at higher risk of distress both at diagnosis and follow-up. Young women with breast cancer face a variety of problems unique to or accentuated by their young age (1). They are more likely to be diagnosed at a stage in life when they fill multiple roles that may not easily be taken over by others (e.g. parenting of young children, completing education, developing a career). Concerns with attractiveness and fertility are often of substantial importance in this population, as many young women are interested in having biologic children following treatment. They also have a greater risk of harboring a genetic risk factor for breast cancer than older patients. Finally, more than older women with breast cancer, who represent the majority of women with the disease, young women often feel isolated and feel that they lack information, and they sometimes are concerned that their doctors are unsure of how to treat them (2,3). Distress may be confounded by a lack of information, provider awareness, peer support, and resources to address young women's concerns, which may contribute to the greater psychosocial distress seen in younger women at both diagnosis and in follow-up compared with older women (4-14). Thus, attention to these concerns in young breast cancer patients is warranted.
Available evidence, however, suggests that attention to important supportive care and survivorship issues including fertility, menopausal concerns, body image, sexual functioning, genetic risk, and psychosocial health have been repeatedly found to be deficient in treatment of young women (15,23-28). Many groups, including ours, have demonstrated that there are substantial inadequacies in attention to fertility and menopausal risks in this population despite recent guidelines recommending their consideration with every young patient (15-20).
Weight gain is another common concern in women diagnosed with breast cancer and has been associated with reductions in physical activity. Studies have demonstrated that 68% of women with early stage breast cancer gain weight after diagnosis and women who receive chemotherapy are at highest risk of weight gain, especially premenopausal women who go through menopause with treatment (33-36). Some evidence suggests that exercise may help prevent treatment-related weight gain and improve psychological outcomes in women diagnosed with early stage breast cancer (38-40). Importantly, exercise and lack of weight gain have been repeatedly associated with improved disease outcomes in breast cancer survivors (41-43).
Again, available evidence suggests the majority of breast cancer survivors do not participate in regular physical activity and that there is clearly room for improvement (43-45). Currently, encouraging physical activity is not a well-recognized standard in breast cancer care, and interventions to assist patients and providers to increase patient exercise behaviors in standard oncology care are needed.
Among older women, access to information and psychosocial support is associated with better quality of life in breast cancer survivors. However, there are no data available to indicate how these processes operate in younger women specifically or what services might mitigate psychosocial distress (29-32). We believe that attention to the issues in young women with breast cancer that are outlined above may be associated with better satisfaction with quality of care and treatment decisions, decreased distress, and better overall quality of life.
To address these critical issues, we have developed a comprehensive Program for Young Women with Breast Cancer at Dana-Farber Cancer Institute (DFCI) to provide additional care, support, and education for young women with breast cancer. Based on the preliminary success of this program, we seek to export this unique model of care to young women with breast cancer who receive care outside of comprehensive cancer centers in an effort to improve the quality of care delivered, the satisfaction with care, and the psychosocial well-being of this vulnerable population.
In the proposed study, we will build on our previous work that developed and piloted an educational and support intervention to improve the quality of care delivered to young women with breast cancer. To achieve these aims, we have created educational interventions focused on issues faced by young women with breast cancer, including but not limited to fertility, satisfaction with care, and physical activity. We will use piloted components of the Program for Young Women with Breast Cancer, as well as piloted exercise intervention materials, to create two educational interventions for this population.
We plan to evaluate both interventions in a randomized controlled trial (RCT) in which community and academic practices and their respective patients will be randomized to an intervention that either focuses on issues unique to young women with breast cancer (Young Women's Intervention, or YWI) or one that focuses on leading a healthy lifestyle as a breast cancer patient (Physical Activity Intervention, or PAI). The rigorous study design of this research will provide important information on the effects of these interventions to improve the care of young women with breast cancer. Therefore, through our intervention, we hope to elucidate what factors might improve quality of life in young women with breast cancer. Ultimately, this work should provide a model for intervening to improve the care of other unique populations.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
|Condition ICMJE||Breast Cancer|
|Publications *||Greaney ML, Sprunck-Harrild K, Ruddy KJ, Ligibel J, Barry WT, Baker E, Meyer M, Emmons KM, Partridge AH. Study protocol for Young & Strong: a cluster randomized design to increase attention to unique issues faced by young women with newly diagnosed breast cancer. BMC Public Health. 2015 Jan 31;15:37. doi: 10.1186/s12889-015-1346-9.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||610|
|Estimated Completion Date||August 2020|
|Primary Completion Date||August 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 45 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01647607|
|Other Study ID Numbers ICMJE||DFCI 12-101|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute|
|Study Sponsor ICMJE||Dana-Farber Cancer Institute|
|Collaborators ICMJE||American Society of Clinical Oncology|
|PRS Account||Dana-Farber Cancer Institute|
|Verification Date||May 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP