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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael F. Scheier, Carnegie Mellon University
ClinicalTrials.gov Identifier:
NCT00416572
First received: December 27, 2006
Last updated: September 21, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention
Breast Neoplasms
Behavioral: Education Intervention
Behavioral: Nutrition Education Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Adjustment to Breast Cancer Among Younger Women

Resource links provided by NLM:


Further study details as provided by Carnegie Mellon University:

Primary Outcome Measures:
  • 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). [ Time Frame: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention). ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention) ] [ Designated as safety issue: No ]
    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).


Enrollment: 252
Study Start Date: January 1997
Study Completion Date: April 2006
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416572

Sponsors and Collaborators
Carnegie Mellon University
National Cancer Institute (NCI)
Investigators
Study Chair: Michael Scheier, PhD Pittsburgh Mind-Body Center at Carnegie Mellon University
  More Information

Responsible Party: Michael F. Scheier, Professor of Psychology, Carnegie Mellon University
ClinicalTrials.gov Identifier: NCT00416572     History of Changes
Other Study ID Numbers: CMU-00000603  5R01CA064711 
Study First Received: December 27, 2006
Results First Received: August 25, 2015
Last Updated: September 21, 2016
Health Authority: United States: Federal Government

Keywords provided by Carnegie Mellon University:
psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on December 09, 2016