Breast Cancer, Cognitive/Functional Effects, Fatigue, Psychosocial Effects of Cancer and Its Treatment
Conditions
Keywords
cognitive/functional effects, fatigue, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief summary
RATIONALE: Studying cognitive function, such as thinking, attention, concentration, and memory, in postmenopausal women receiving hormone therapy for breast cancer may help improve quality of life and the ability to plan treatment for cancer. PURPOSE: This phase III trial is studying cognitive function in postmenopausal women with breast cancer receiving hormone therapy on clinical trial IBCSG-1-98.
Detailed description
OBJECTIVES: Primary * Compare cognitive function in postmenopausal women with breast cancer who have received 5 years of adjuvant tamoxifen vs letrozole on protocol IBCSG-1-98. Secondary * Compare cognitive function in patients who have received a single hormonal therapy for 5 years vs those who have received that same hormonal therapy for 3 years, having previously received an alternate hormonal therapy for 2 years. * Compare improvement in cognitive function 1 year after cessation of adjuvant hormonal therapy. * Compare changes in cognitive function in patients who have received prior adjuvant chemotherapy vs those who have not received adjuvant chemotherapy. * Assess the relationship between objective and subjective measures of cognitive function, including specific cognitive domains. * Assess the relationship between cognitive function and psychological distress, fatigue, and quality of life. OUTLINE: This is a longitudinal, multicenter study. Patients undergo cognitive function testing and complete self-reported questionnaires regarding cognitive ability, quality of life, fatigue, and psychosocial status during the fifth year of adjuvant hormonal therapy on protocol IBCSG-1-98 and then during the sixth year\* (post randomization on protocol IBCSG-1-98) (i.e., after completion of adjuvant hormonal therapy). NOTE: \*Patients who receive extended letrozole, hormone replacement therapy, or other endocrine therapy beyond 5 years do not undergo the 6-year assessment. PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
Interventions
PROCEDUREcognitive assessment
Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.
PROCEDUREfatigue assessment and management
Fatigue will be evaluated using the Brief Fatigue Inventory.
PROCEDUREpsychologic distress
Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.
PROCEDUREquality-of-life assessment
Quality of life will be assessed using global linear analogue self-assessment (LASA) indicators for physical well-being, mood, coping effort (PACIS), perceived social support and subjective health estimation.
Sponsors
ETOP IBCSG Partners Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Enrolled in protocol IBCSG-1-98 * Must be in the fifth year of study treatment (i.e., still receiving tamoxifen or letrozole) * No breast cancer recurrence or second malignancy * Patients who received 2-4½ years of tamoxifen and have chosen to switch to letrozole to complete 5 years of treatment on protocol IBCSG-1-98 are not eligible * Hormone receptor status * Estrogen receptor- and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective cognitive function as measured by the CogState battery | 6 years after randomization |
Secondary
| Measure | Time frame |
|---|---|
| Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ) | 6 years after randomization |
| Psychological distress as measured by the General Health Questionnaire (GHQ) | 6 years after randomization |
| Fatigue as measured by the Brief Fatigue Inventory (BFI) | 6 years after randomization |
| Quality of life as measured by the IBCSG QL Core Form | 6 years after randomization |
Countries
Australia, Belgium, Italy, New Zealand, Switzerland, United Kingdom
Outcome results
None listed