Pilot Study for Young Women's Intervention (YWI Pilot)
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|ClinicalTrials.gov Identifier: NCT01647594|
Recruitment Status : Completed
First Posted : July 23, 2012
Last Update Posted : January 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: YWI Behavioral: Physical Activity||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Qualitative Assessment and Pilot Study for Young Women's Intervention|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Active Comparator: Young Women's Intervention (YWI)||
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.
|Active Comparator: Physical Activity Intervention (PAI)||
Behavioral: Physical Activity
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.
- Efficacy of intervention materials in addressing the unique issues facing young women with breast cancer [ Time Frame: 1 year ]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.
- Evaluate process of intervention [ Time Frame: 1 year ]This pilot study is being conducted at 4 unique sites to assess the feasibility of recruitment and implementation, as well as to pilot the surveys.
- Qualitative assessment of concerns facing young women with breast cancer [ Time Frame: 1 year ]The qualitative assessment will entail moderated in-person focus groups and key informant phone interviews, both of which will explore issues concerning young women with newly-diagnosed breast cancer. The following domains will be assessed: 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.
- Efficacy of materials for helping providers improve cancer treatment for young women with breast cancer [ Time Frame: Baseline, and about one week later ]During the pilot intervention, we will pilot two patient surveys and one provider survey for material content and feedback on the intervention materials.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647594
|United States, Maine|
|Eastern Maine Medical Center|
|Brewer, Maine, United States, 04412|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Lowell General Hospital|
|Lowell, Massachusetts, United States, 01854|
|United States, Texas|
|Texas Oncology Cancer Center|
|Houston, Texas, United States, 77024|
|Principal Investigator:||Ann H. Partridge, M.D., M.P.H.||Dana-Farber Cancer Institute|