Clinical Trial

Breast Cancer Research and Treatment

, Volume 109, Issue 3, pp 515-526

First online:

Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): psychometric properties of a new measure of symptoms for midlife women

  • David CellaAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Center on Outcomes, Research and Education, Evanston Northwestern Healthcare 1001 University PlaceInstitute for Healthcare Studies and Robert H. Lurie Comprehensive Cancer Center, Northwestern University Medical School Email author 
  • , Stephanie R. LandAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)NSABP Biostatistical CenterDepartment of Biostatistics, Graduate School of Public Health, University of Pittsburgh
  • , Chih-Hung ChangAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Institute for Healthcare Studies and Robert H. Lurie Comprehensive Cancer Center, Northwestern University Medical SchoolBuehler Center on Aging, Health & Society, Feinberg School of Medicine, Northwestern University
  • , Richard DayAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh
  • , Joseph P. CostantinoAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)NSABP Biostatistical CenterDepartment of Biostatistics, Graduate School of Public Health, University of Pittsburgh
  • , Norman WolmarkAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Allegheny General Hospital
  • , Patricia A. GanzAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Schools of Medicine and Public Health, and the Jonsson Comprehensive Cancer Center, University of California

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

Abstract

Purpose: To evaluate scalability of a symptom scale administered to women enrolled in the Breast Cancer Prevention Trial (BCPT) (P-1) conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP).Patients and methods: Responses of 11,064 women recruited into a study of 20 mg daily tamoxifen versus placebo to prevent breast cancer in high-risk women were analyzed. Exploratory factor analyses of the 12 month data were conducted on a random subset of 4,000 women to estimate the factor structure. Baseline data on these same 4,000 women were analyzed to confirm the structure. The remaining sample was divided randomly into two data sets. Data on each set were then grouped by age (35–49, 50–59, or ≥60 years) and treatment (tamoxifen or placebo) to corroborate these analyses. Correlations between the obtained symptom clusters and two standard instruments (SF-36 and CES-D) were examined. Content analysis of open-ended responses was also conducted.Results: Eight clinically-interpretable clusters of symptoms were identified and confirmed: Cognitive symptoms, musculoskeletal pain, vasomotor symptoms, nausea, sexual problems, bladder problems, body image, and vaginal symptoms. Scoring for each scale represented by these eight clusters is provided. Content analysis of open-ended responses suggested four items that are additional candidates: fatigue, back problems, abdominal pain, and leg/foot cramps or pain. Conclusions: Symptoms associated with hormone therapy for breast cancer can vary. Nevertheless, the BCPT Eight Symptom Scale (BESS) can be clustered into clinically relevant and reproducible factors that may be useful in future outcomes research.

Keywords

Breast cancer Breast cancer prevention Symptoms Scale Eight Menopausal Endocrine NSABP NHLBI (PEPI) BCPT P-1