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

NCT00343616 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2012-07-27

No results posted yet for this study

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.

Conditions

  • Breast Cancer
  • Cognitive/Functional Effects
  • Fatigue
  • Psychosocial Effects of Cancer and Its Treatment

Interventions

PROCEDURE

cognitive assessment

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

PROCEDURE

fatigue assessment and management

Fatigue will be evaluated using the Brief Fatigue Inventory.

PROCEDURE

psychologic distress

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

PROCEDURE

quality-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 & Collaborators

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Kelly-Anne Phillips · Peter MacCallum Cancer Centre, Australia

  • Juerg Bernhard, PhD · ETOP IBCSG Partners Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2008-05-31
Completion
2009-05-31

Countries

  • Australia
  • Belgium
  • Italy
  • New Zealand
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00343616 on ClinicalTrials.gov