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

Not Applicable

Completed

Conditions: Breast Neoplasms

Interventions: Behavioral: Nutrition Education Intervention
Behavioral: Education Intervention

Registration Number: NCT00416572

Lead Sponsor: Carnegie Mellon University

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 252

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Education Intervention	Nutrition Education Intervention	Participants attended 4 2-hr nutrition education sessions. Each session provided information and encouragement on setting and attaining measurable goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems in life and living a healthy lifestyle.
Education Intervention	Education Intervention	Participants attended 4 2-hr education sessions. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness and its treatment, to enhance coping in productive ways with the issues and problems confronting them, and to facilitate communication between the participants and their partners.

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).	Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).	Scores for the shortened form of the Center for Epidemiologic Studies Depression scale(CES-D) ranged from 0 (no depressive symptoms) to 24 (high levels of depressives symptoms) in the present sample.
Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)	Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)	The Perceived Physical Health Component scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: Physical functioning, bodily pain, role limitations due to physical problems and general health. In the present study, scores ranged from a maximum of 68 (high levels of perceived health) to a minimum of 24 (low levels of perceived health).
Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)	Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)	The Mental Health Component Scale of the Medical Outcomes Study Short Form 36 (SF-36) consists of a norm-based weighted average of the following subscales: vitality, social functioning, role limitations due to emotional problems and mental health. In the present study, scores ranged from a maximum of 68 (high levels of mental health) to a minimum of 15 (low levels of mental health).