Pilot Study for Young Women's Intervention

NCT01647594 | Completed DMC

• 1 other identifier: 10-390
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 4

Brief 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

Breast Cancer

Keywords

Breast cancer; Young women; Fertility; Physical activity; Survivorship

Outcome Measures

Primary Outcomes (3)

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

  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.

  1 year

• Evaluate process of intervention

  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.

  1 year

• Qualitative assessment of concerns facing young women with breast cancer

  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.

  1 year

Secondary Outcomes (1)

• Efficacy of materials for helping providers improve cancer treatment for young women with breast cancer

  Baseline, and about one week later

Study Arms (2)

Young Women's Intervention (YWI)

ACTIVE COMPARATOR

Behavioral: YWI

Physical Activity Intervention (PAI)

ACTIVE COMPARATOR

Behavioral: Physical Activity

Interventions

YWI BEHAVIORAL

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.

Young Women's Intervention (YWI)

Physical Activity BEHAVIORAL

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.

Physical Activity Intervention (PAI)

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• American Society of Clinical Oncology: collaborator

Study Sites (4)

Eastern Maine Medical Center

Brewer, Maine, 04412, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Texas Oncology Cancer Center

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ann H. Partridge, M.D., M.P.H.

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: July 23, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

US (4)