NCT00416572

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

Adjustment to Breast Cancer Among Younger Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (actual)
• Sponsor: Carnegie Mellon University · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Educational programs may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer. PURPOSE: To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer.

Detailed description

OBJECTIVES: * Design, implement, and evaluate an educational intervention and a nutrition education 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 interventions affect quality of life. * Assess whether the interventions are 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 2 intervention groups or a control condition. * Arm I (control group): Patients did not undergo any intervention. Patients were evaluated at baseline and at 4 and 13 months. * Arm II (breast cancer education group): Patients attended a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months. Sessions involved the presentation of information concerning breast cancer, followed by a guided discussion of related topics. Sessions topics included: talking with children about cancer, life after diagnosis, relationships/intimacy, and hormones and breast cancer/basic factors of heredity. Patients were also given booklets and brochures to read at home. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention. * Arm III (nutritional education group): Patients attended a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months. Sessions involved the presentation of information concerning nutrition, followed by a guided discussion of related topics. Session topics included: healthy cupboards, what's cooking, shopping for success, and out on the town. Patients were also asked to keep a 4 day record of diet. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	Education Intervention	Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer and how to create a safe environment for them; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read.
BEHAVIORAL	Nutrition Education Intervention	The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it.

Timeline

• Start date: 1997-01-01
• Primary completion: 2001-05-01
• Completion: 2006-04-01
• First posted: 2006-12-28
• Last updated: 2016-11-07
• Results posted: 2016-11-07