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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:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416572
First received: December 27, 2006
Last updated: May 29, 2013
Last verified: October 2007
  Purpose

RATIONALE: An educational program may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer.

PURPOSE: This randomized clinical trial is studying how well an educational program works in helping younger women cope with the recent diagnosis of and treatment for stage I or stage II breast cancer.


Condition Intervention
Breast Cancer
Psychosocial Effects of Cancer and Its Treatment
Behavioral: behavioral dietary intervention
Other: educational intervention
Other: preventative dietary intervention
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Official Title: Adjustment to Breast Cancer Among Younger Women

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 264
Study Completion Date: April 2006
Detailed Description:

OBJECTIVES:

  • Design, implement, and evaluate an educational 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 intervention affects quality of life.
  • Assess whether the intervention was 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 3 intervention groups.

  • Arm I (control group): Patients do not undergo any intervention. Patients are evaluated at baseline and at 4 and 13 months.
  • Arm II (breast cancer education group): Patients attend a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months. Patients view a 1-hour video about breast cancer after the second and fourth sessions and may be asked to complete written exercises at home. Patients are evaluated at baseline, after treatment, and at 9 months after treatment.
  • Arm III (nutritional education group): Patients attend a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months. Patients view a 1-hour video about nutrition after the second and fourth sessions. Patients are required to keep a record of diet and may be asked to complete written exercises or workbook assignments at home. Patients are evaluated at baseline, after treatment, and at 9 months after treatment.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

PATIENT CHARACTERISTICS:

  • Female patients only
  • Must be able to communicate
  • No 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
Pittsburgh Mind-Body Center at Carnegie Mellon University
Investigators
Study Chair: Michael Scheier, PhD Pittsburgh Mind-Body Center at Carnegie Mellon University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00416572     History of Changes
Other Study ID Numbers: CMU-00000603, PMBC-HS05-138, CDR0000459746, FWA00004206, MWH-99-062
Study First Received: December 27, 2006
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer

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

ClinicalTrials.gov processed this record on November 25, 2014