Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer

Breast Cancer Clinical Trial

Official title:

Adjustment to Breast Cancer Among Younger Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416572
• Other study ID #: CMU-00000603
• Secondary ID: PMBC-HS05-138CDR
• Status: Completed
• Phase: N/A
• First received: December 27, 2006
• Last updated: May 29, 2013
• Est. completion date: April 2006

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: An educational program may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer.

PURPOSE: This randomized clinical trial is studying how well an educational program works in helping younger women cope with the recent diagnosis of and treatment for stage I or stage II breast cancer.

Description:

OBJECTIVES:

• Design, implement, and evaluate an educational intervention specifically aimed at improving adjustment among younger women who have been newly diagnosed with and treated for stage I or II breast cancer and who are ending the active phase of treatment.

• Determine the processes through which the intervention affects quality of life.

• Assess whether the intervention was differentially effective for different groups of women.

• Determine how women who decline participation differ from those who participate.

• Determine the nature and extent of adjustment difficulties, using baseline data, in younger women living in an urban setting who have been treated for early stage breast cancer.

• Identify personality and situational correlates of individuals who adapt well to early-stage breast cancer diagnosis and treatment and those who do not.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 intervention groups.

• Arm I (control group): Patients do not undergo any intervention. Patients are evaluated at baseline and at 4 and 13 months.

• Arm II (breast cancer education group): Patients attend a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months. Patients view a 1-hour video about breast cancer after the second and fourth sessions and may be asked to complete written exercises at home. Patients are evaluated at baseline, after treatment, and at 9 months after treatment.

• Arm III (nutritional education group): Patients attend a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months. Patients view a 1-hour video about nutrition after the second and fourth sessions. Patients are required to keep a record of diet and may be asked to complete written exercises or workbook assignments at home. Patients are evaluated at baseline, after treatment, and at 9 months after treatment.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 49 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

• Stage I or II disease

• No more than 10 positive lymph nodes

• First-time diagnosis

• Under the age of 50 at diagnosis

• Finished active treatment within the past 2 months

• English-speaking only

• Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania

PATIENT CHARACTERISTICS:

• Female patients only

• Must be able to communicate

• No other prior malignancies except skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Behavioral:
• behavioral dietary intervention

Other:
• educational intervention

• preventative dietary intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pittsburgh Mind-Body Center at Carnegie Mellon University	National Cancer Institute (NCI)