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

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education Intervention
Nutrition Education Intervention
Sponsored by
Carnegie Mellon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasms focused on measuring psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Education Intervention

    Nutrition Education Intervention

    Control Condition

    Arm Description

    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.

    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.

    Participants received care as usual.

    Outcomes

    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).
    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)
    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)
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    December 27, 2006
    Last Updated
    September 21, 2016
    Sponsor
    Carnegie Mellon University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00416572
    Brief Title
    Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer
    Official Title
    Adjustment to Breast Cancer Among Younger Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1997 (undefined)
    Primary Completion Date
    May 2001 (Actual)
    Study Completion Date
    April 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Carnegie Mellon University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasms
    Keywords
    psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    252 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Education Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Nutrition Education Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Condition
    Arm Type
    No Intervention
    Arm Description
    Participants received care as usual.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education Intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrition Education Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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).
    Description
    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.
    Time Frame
    Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).
    Title
    Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
    Description
    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).
    Time Frame
    Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)
    Title
    Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
    Description
    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).
    Time Frame
    Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Scheier, PhD
    Organizational Affiliation
    Pittsburgh Mind-Body Center at Carnegie Mellon University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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