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Qualitative Assessment and Pilot Study for Young Women's Intervention

18 Years
46 Years
Not Enrolling
Breast Cancer

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Trial Information

Qualitative Assessment and Pilot Study for Young Women's Intervention

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.

Inclusion Criteria:

- Able to read and write English

- Age 18-42 at time of diagnosis

- Within 4 years of stage I-III invasive breast cancer diagnosis

- No known recurrence or metastatic disease

- Subject can be under active treatment at the time of study participation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Efficacy of intervention materials in addressing the unique issues facing young women with breast cancer

Outcome Description:

Through focus groups and a pilot study, we will evaluate materials developed to provide young women newly diagnosed with breast cancer information and resources regarding their unique concerns or physical activity.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ann H. Partridge, M.D., M.P.H.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

March 2011

Completion Date:

July 2012

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Young women
  • Fertility
  • Physical activity
  • Survivorship
  • Breast Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Eastern Maine Medical CenterBangor, Maine  04401
Lowell General HospitalLowell, Massachusetts  01854
Texas Oncology Cancer CenterAustin, Texas  78731