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Pilot Study for Young Women's Intervention

NCT01647594 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2013-01-07

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Ann H. Partridge, M.D., M.P.H. · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01647594 on ClinicalTrials.gov