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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms
• Intervention / Treatment: Behavioral: Education Intervention; Behavioral: Nutrition Education Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 252
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

INCLUSION CRITERIA (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

INCLUSION CRITERIA (Patient Characteristics):

• Female patients only
• Must be able to communicate

EXCLUSION CRITERIA (Patient Characteristics):

• Other prior malignancies except skin cancer

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
No Intervention: Control Condition; Participants received care as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Carnegie Mellon University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Primary Completion (Actual): May 1, 2001
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: December 27, 2006
• First Submitted That Met QC Criteria: December 27, 2006
• First Posted (Estimate): December 28, 2006

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: stage II breast cancer; stage I breast cancer; psychosocial effects of cancer and its treatment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CMU-00000603 (cmu); 5R01CA064711 (U.S. NIH Grant/Contract)