Breast Cancer Clinical Trial
Official title:
Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer
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.
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