Pilot Study for Young Women's Intervention (YWI Pilot)

This study has been completed.
Sponsor:
Collaborator:
American Society of Clinical Oncology
Information provided by (Responsible Party):
Ann H. Partridge, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01647594
First received: October 26, 2011
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Breast Cancer
Behavioral: YWI
Behavioral: Physical Activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Qualitative Assessment and Pilot Study for Young Women's Intervention

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Efficacy of intervention materials in addressing the unique issues facing young women with breast cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Efficacy of materials for helping providers improve cancer treatment for young women with breast cancer [ Time Frame: Baseline, and about one week later ] [ Designated as safety issue: No ]
    During the pilot intervention, we will pilot two patient surveys and one provider survey for material content and feedback on the intervention materials.


Enrollment: 93
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Young Women's Intervention (YWI) 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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647594

Locations
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
Sponsors and Collaborators
Dana-Farber Cancer Institute
American Society of Clinical Oncology
Investigators
Principal Investigator: Ann H. Partridge, M.D., M.P.H. Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Ann H. Partridge, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01647594     History of Changes
Other Study ID Numbers: 10-390
Study First Received: October 26, 2011
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Breast cancer
Young women
Fertility
Physical activity
Survivorship

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014