Cognitive Function in Postmenopausal Women With Breast Cancer Receiving Hormone Therapy on Clinical Trial IBCSG-1-98

Study Overview
=================
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.

Official Title
-----------------
Investigating Cognitive Function for Patients Participating in the BIG Trial 1-98 in Select Centers

Conditions
-----------------
Breast Cancer, Cognitive/Functional Effects, Fatigue, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
-----------------
* Procedure: cognitive assessment
* Procedure: fatigue assessment and management
* Procedure: psychologic distress
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamoxifen for 5 years<br>Patients treated with tamoxifen for 5 years after randomization. | Procedure: cognitive assessment<br>* Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.<br>Procedure: fatigue assessment and management<br>* Fatigue will be evaluated using the Brief Fatigue Inventory.<br>Procedure: psychologic distress<br>* Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.<br>Procedure: quality-of-life assessment<br>* 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.<br>|
| Experimental: Letrozole for 5 years<br>Patients treated with letrozole for 5 years after randomization. | Procedure: cognitive assessment<br>* Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.<br>Procedure: fatigue assessment and management<br>* Fatigue will be evaluated using the Brief Fatigue Inventory.<br>Procedure: psychologic distress<br>* Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.<br>Procedure: quality-of-life assessment<br>* 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.<br>|
| Experimental: Tamoxifen 2 years plus letrozole 3 years<br>Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years. | Procedure: cognitive assessment<br>* Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.<br>Procedure: fatigue assessment and management<br>* Fatigue will be evaluated using the Brief Fatigue Inventory.<br>Procedure: psychologic distress<br>* Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.<br>Procedure: quality-of-life assessment<br>* 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.<br>|
| Experimental: Letrozole for 2 years plus tamoxifen for 3 years<br>Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years. | Procedure: cognitive assessment<br>* Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.<br>Procedure: fatigue assessment and management<br>* Fatigue will be evaluated using the Brief Fatigue Inventory.<br>Procedure: psychologic distress<br>* Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.<br>Procedure: quality-of-life assessment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective cognitive function as measured by the CogState battery |  | 6 years after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cognitive/functional effects, fatigue, psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer