Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 467
- 试验地点
- 8
- 主要终点
- Comparison of attention rates in the YWI and the PAI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Comparison of attention rates in the YWI and the PAI
时间窗: 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.
次要结局
- Effect of the PAI on improvement of exercise behaviors(3 Months Post-Enrollment)
- Relationship between attention rate and quality of care within each arm (YWI and PAI)(3 Months Post-Enrollment)
- Effect of demographics on the YWI(3, 6, and 12 Months Post-Enrollment)
- Effects of the PAI on changes in physical activity based on MVA at three months(3 Months Post-Enrollment)
- The effect of the YWI on quality of care measures(3, 6, and 12 Months Post-Enrollment)
- Effect of the YWI on maintenance of the attention rate(6 Months Post-Enrollment)
- Effect of the PAI on maintenance of exercise behaviors(6 and 12 Months Post-Enrollment)
研究者
Ann H. Partridge, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
