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Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer


N/A
18 Years
45 Years
Open (Enrolling by invite only)
Female
Breast Cancer

Thank you

Trial Information

Young and Strong: An Education and Supportive Care Intervention Study for Young Women With Breast Cancer


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.


Inclusion Criteria:



- Female age 18-45 years at diagnosis

- Within 3 months of stage I-III invasive breast cancer diagnosis

- No known recurrence or metastatic disease

- Able to read and write in English

- Has first appointment with medical oncologist after the provider's practice is
enrolled in the study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Comparison of attention rates in the YWI and the PAI

Outcome Description:

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.

Outcome Time Frame:

3 Months Post-Enrollment

Safety Issue:

No

Principal Investigator

Ann H Partridge, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

DFCI 12-101

NCT ID:

NCT01647607

Start Date:

June 2012

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Young Women
  • Fertility
  • Physical Activity
  • Survivorship
  • Breast Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
University of MichiganAnn Arbor, Michigan  48109-0624
Roswell Park Cancer InstituteBuffalo, New York  14263
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Fox Valley Hematology and OncologyAppleton, Wisconsin  54911
University of WashingtonSeattle, Washington  98195
University of North CarolinaChapel Hill, North Carolina  27599
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
West ClinicMemphis, Tennessee  38117
Emory UniversityAtlanta, Georgia  30322
Albert Einstein Medical CenterPhiladelphia, Pennsylvania  19141
Ohio State UniversityColumbus, Ohio  43210
Providence Portland Medical CenterPortland, Oregon  97213-3635
University of ChicagoChicago, Illinois  60637
Indiana UniversityIndianapolis, Indiana  46202
Edward HospitalNaperville, Illinois  60566
Billings ClinicBillings, Montana  59107-7000
Northern Westchester HospitalMount Kisco, New York  10549
Cookeville Regional Medical CenterCookeville, Tennessee  38501
Baptist Hospital EastLouisville, Kentucky  40207
Norton Cancer InstituteLouisville, Kentucky  40207
St. Francis Medical CenterGrand Island, Nebraska  68803
NorthShore University HealthSystemEvanston, Illinois  
MaineGeneral Medical CenterAugusta, Maine  
Christus St. Frances Cabrini HospitalAlexandria, Louisiana  71301
Space Coast Cancer CenterTitusville, Florida  32796
Cancer Center of South FloridaLake Worth, Florida  33461
Self Regional HealthcareGreenwood, South Carolina  29646
Santa Monica Hematology-Oncology ConsultantsSanta Monica, California  90404
Penrose St. Francis Health ServicesColorado Springs, Colorado  80907
Oncology Specialists Research InstituteNiles, Illinois  60714
Overland Park Regional Medical CenterOverland Park, Kansas  66209
Center for Breast HealthBethesda, Maryland  20817
St. Luke's Hospital of Kansas CityKansas City, Missouri  64111
South Shore Hematology OncologyValley Stream, New York  11580
Oncology Specialists of CharlotteCharlotte, North Carolina  28207
Baptist Hospital of Southeast TexasBeaumont, Texas  77701
Texas Oncology- Round RockRound Rock, Texas  78681
Shenandoah OncologyWinchester, Virginia  22601
Gundersen Lutheran, Ltd.LaCrosse, Wisconsin  54601