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

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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.

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Acknowledgements

Supported by Public Health Service grants U10CA-37377, and U10CA-69974 from the National Cancer Institute, Department of Health and Human Services.

The authors thank Barbara C. Good, PhD, Director of Scientific Publications for the NSABP, and Wendy L. Rea, for editorial assistance.

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Authors and Affiliations

  1. National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, US

    David Cella, Stephanie R. Land, Chih-Hung Chang, Richard Day, Joseph P. Costantino, Norman Wolmark & Patricia A. Ganz

  2. Center on Outcomes, Research and Education, Evanston Northwestern Healthcare 1001 University Place, Suite 101, Evanston, IL, 60201, US

    David Cella

  3. Institute for Healthcare Studies and Robert H. Lurie Comprehensive Cancer Center, Northwestern University Medical School, Evanston, IL, US

    David Cella & Chih-Hung Chang

  4. NSABP Biostatistical Center, Pittsburgh, PA, US

    Stephanie R. Land & Joseph P. Costantino

  5. Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, US

    Stephanie R. Land, Richard Day & Joseph P. Costantino

  6. Buehler Center on Aging, Health & Society, Feinberg School of Medicine, Northwestern University, Chicago, IL, US

    Chih-Hung Chang

  7. Allegheny General Hospital, Pittsburgh, PA, US

    Norman Wolmark

  8. Schools of Medicine and Public Health, and the Jonsson Comprehensive Cancer Center, University of California, Los Angeles, CA, US

    Patricia A. Ganz

Authors
  1. David Cella
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  2. Stephanie R. Land
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  3. Chih-Hung Chang
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  4. Richard Day
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  5. Joseph P. Costantino
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  6. Norman Wolmark
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  7. Patricia A. Ganz
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Corresponding author

Correspondence to David Cella.

Additional information

Trial registration: Cancer.gov URL for BCPT/P-1: http://www.cancer.gov/search/ResultsClinicalTrialsAdvanced.aspx?protocolsearchid = 3071847

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Cella, D., Land, S.R., Chang, CH. et al. Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): psychometric properties of a new measure of symptoms for midlife women. Breast Cancer Res Treat 109, 515–526 (2008). https://doi.org/10.1007/s10549-007-9682-9

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  • DOI: https://doi.org/10.1007/s10549-007-9682-9

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