Pilot Study for Young Women's Intervention
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This is a pilot study, which will inform a larger study to evaluate the Young Women's
      Intervention (YWI). The goal of this research is to develop, implement and test a refined
      exportable and sustainable education and support intervention for young women with breast
      cancer and their oncology providers. This pilot study will test the feasibility of the Young
      Women's Intervention (YWI) as well as a Physical Activity Intervention (PAI) at four unique
      sites. In addition, it will include a qualitative assessment, through focus groups and key
      informant interviews, of concerns facing young women with breast cancer. The investigators
      aim to use the findings from this pilot study to inform a larger future Young Women's
      Intervention (YWI) study where the YWI intervention will be compared to a Physical Activity
      Intervention (PAI).
    

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
      2,000 are diagnosed with noninvasive disease. 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. Further, in addition to being at higher
      risk of dying from breast cancer, despite often receiving more aggressive therapy, young
      women are at higher risk of distress both at diagnosis and in follow-up. Young women often
      have multiple roles and responsibilities that are harder to adjust to or get others to take
      on (e.g., parenting of young children, completing education, or building a career). Many
      young women are interested in having biologic children following treatment and are concerned
      about their future fertility. They also have an increased risk of harboring a genetic risk
      factor for breast cancer. Finally, in contrast to older women with breast cancer, who
      represent the majority of women with the disease, young women often feel isolated and lacking
      information, and they sometimes are concerned that their doctors are unsure of how to treat
      them. Distress may be confounded by lack of information on some of the risks they face, lack
      of provider awareness, information, and resources to address young women's concerns, and lack
      of peer support. These issues may contribute to the greater psychosocial distress seen in
      younger women at both diagnosis and in follow-up compared with older women. Thus, attention
      to these issues in younger women is warranted. Yet, research has revealed that needs of young
      women are not being met.

      The primary goals of this study are to:

        1. conduct a qualitative assessment, through focus groups and key informant interviews, of
           concerns facing young women with breast cancer;

        2. evaluate materials developed to provide young women newly diagnosed with breast cancer
           information and resources regarding their unique concerns or physical activity through
           focus groups and a pilot study;

        3. conduct a pilot study of the Young Women's Intervention (YWI) as well as a Physical
           Activity Intervention (PAI) at 4 unique sites (3 will use the YWI and 2 will use the
           PAI- DFCI will pilot both interventions, one following the other) to evaluate the
           process for the intervention as well as to pilot surveys.

      We aim to use the findings from the focus groups, key informant interviews and pilot study to
      inform the larger future Young Women's Intervention (YWI) study where the YWI arm will be
      compared to a Physical Activity Intervention (PAI). We plan to develop, implement and test a
      refined exportable and sustainable education and support intervention for young women with
      breast cancer and their oncology providers. First, we want to conduct focus groups and key
      informant interviews aiming to qualitatively assess the following domains: health/medical
      issues (i.e. side effects, breast cancer recurrence, long-term risks, genetic issues),
      psychosocial issues (coping, relationship and family concerns), beauty/body image, sexual
      functioning, fertility concerns, and work/school issues. In addition, the focus groups will
      be used to review the study materials and provide constructive feedback. In order to get a
      more diverse view of young women's concerns, we will conduct key informant interviews by
      telephone with young women with a history of breast cancer recruited from various regions of
      the country.

      Information gained through the focus groups, key informant interviews and pilot of the
      intervention at four diverse practices will help us discover and resolve issues related to:
      administering the baseline survey, follow-up survey and provider survey; ensuring that the
      adapted intervention meets patient and provider needs, and evaluation the implementation
      process. When evaluating the patient surveys, investigators will assess issues that may have
      posed a barrier to patients' comprehension of study questions, such as the use of jargon or
      difficult vocabulary. In addition to piloting patient and provider surveys for material
      content, we will evaluate the intervention for feasibility of recruitment and implementation.
      We will refine materials and methods based on our pilot experience.

      Collectively, results from the qualitative assessment and pilot will help finalize materials
      and surveys as well the methods of the study for a planned multi-site intervention study
      (YWI) funded by ASCO with support from Susan G. Komen for the Cure. A detailed plan of the
      parent study intervention will be submitted to the IRB upon completion of the focus groups,
      key informant interviews and pilot study described above.
    

Intervention name(s): YWI; Physical Activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The YWI consists of print and web-based materials. Content for this group will include detailed information about issues facing young women with breast cancer, risks, discussion points and and resources. The following domains will be addressed: health/medical issues (i.e., side effects, breast cancer recurrence, long-term risks, genetic issues), psychosocial issues (coping, relationship and family concerns), beauty/body image, sexual functioning, fertility concerns, and work/school issues.; The PAI serves as the control group. This intervention consists of print and web-based materials, the content of which includes detailed information about the benefits of exercise in breast cancer survivors and discussion points, available options 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