Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Young Women's Intervention (YWI); Physical Activity Intervention (PAI)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Breast Cancer; Young Women; Fertility; Physical Activity; Survivorship