Trial Information

Adjustment to Breast Cancer Among Younger Women

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.