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

NCT00416572 | Completed Results DMC

• 2 other identifiers: CMU-000006035R01CA064711
• Study Type: interventional
• Target: 252
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Keywords

psychosocial effects of cancer and its treatment; stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).

• Perceived Physical Health (Measured With SF-36) at 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).

  Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)

• Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and 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).

  Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)

Study Arms (3)

Education Intervention

EXPERIMENTAL

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.

Behavioral: Education Intervention

Nutrition Education Intervention

EXPERIMENTAL

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.

Behavioral: Nutrition Education Intervention

Control Condition

NO INTERVENTION

Participants received care as usual.

Interventions

Education Intervention BEHAVIORAL

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.

Education Intervention

Nutrition Education Intervention BEHAVIORAL

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.

Nutrition Education Intervention

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Female patients only
• Must be able to communicate

You may not qualify if:

• Other prior malignancies except skin cancer
• PRIOR CONCURRENT THERAPY:
• See Disease Characteristics

Sponsors & Collaborators

• Carnegie Mellon University: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Results Point of Contact

• Title: Michael F. Scheier, PhD
• Organization: Carnegie Mellon University

scheier@cmu.edu

412-268-3791

Study Officials

• Michael Scheier, PhD

  Pittsburgh Mind-Body Center at Carnegie Mellon University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: January 1, 1997
• Primary Completion: May 1, 2001
• Study Completion: April 1, 2006
• Last Updated: November 7, 2016
• Results First Posted: November 7, 2016

Record last verified: 2016-09