Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer
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.
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 Design:||Allocation: Randomized|
|Official Title:||Adjustment to Breast Cancer Among Younger Women|
|Study Completion Date:||April 2006|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416572
|Study Chair:||Michael Scheier, PhD||Pittsburgh Mind-Body Center at Carnegie Mellon University|