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NCT Number: NCT00343616

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cognitive/Functional Effects Fatigue Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Psychosocial Effects of Cancer and Its Treatment Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Oncology at Prince of Wales Hospital, Randwick, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive assessment

Procedure

Cognitive function will be assessed using the CogState battery and the Cognitive Failures Questionnaire.

fatigue assessment and management

Procedure

Fatigue will be evaluated using the Brief Fatigue Inventory.

psychologic distress

Procedure

Psychologic distress will be evaluated using the General Health Questionnaire after cognitive testing.

quality-of-life assessment

Procedure

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.

Primary outcomes

  1. Objective cognitive function as measured by the CogState battery

    Time frame: 6 years after randomization

Secondary outcomes

  1. Subjective cognitive function as measured by the Cognitive Failures Questionnaire (CFQ)

    Time frame: 6 years after randomization

  2. Psychological distress as measured by the General Health Questionnaire (GHQ)

    Time frame: 6 years after randomization

  3. Fatigue as measured by the Brief Fatigue Inventory (BFI)

    Time frame: 6 years after randomization

  4. Quality of life as measured by the IBCSG QL Core Form

    Time frame: 6 years after randomization

Sponsors and collaborators

Lead sponsor

ETOP IBCSG Partners Foundation

Network

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jun 23, 2006
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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