Identification of Latent Classes in Patients Who Are Receiving Biotherapy Based on Symptom Experience and Its Effect on Functional Status and Quality of Life

Marylin Dodd

Maria H. Cho

Bruce A. Cooper

Judy Petersen

Kayee Alice Bank

Kathryn A. Lee

Christine Miaskowski

biotherapy, biotherapy/targeted therapy
ONF 2010, 38(1), 33-42. DOI: 10.1188/11.ONF.33-42

Purpose/Objectives: To identify subgroups of patients receiving biotherapy with pain, fatigue, sleep disturbance, and depression and to determine functional status and quality of life differences between subgroups.

Design: A descriptive, prospective, cohort study design.

Setting: Internet-based survey.

Sample: 187 patients with cancer receiving biotherapy.

Methods: Pain intensity, Piper Fatigue Scale, General Sleep Disturbance Scale, Center for Epidemiological Studies-Depression, Karnofsky Performance Scale, and the Multidimensional Quality of Life Scale-Cancer were used at two time points one month apart (T1 and T2). Latent profile analysis identified subgroups.

Main Research Variables: Biotherapy, symptoms, functional status, and quality of life.

Findings: At T1 (N = 187), five patient subgroups were identified, ranging from subgroup 1 (mild fatigue and sleep disturbance) to subgroup 5 (severe on all four symptoms). At T2 (N = 114), three patient subgroups were identified, ranging from subgroup 1 (mild pain, fatigue, and sleep disturbance without depression) to subgroup 3 (mild pain, moderate fatigue, and sleep disturbance with severe depression). At each time point, the patient subgroup with the most severe symptoms showed significantly lower functional status and quality of life.

Conclusions: As with other cancer treatments, biotherapy can be divided into similar patient subgroups with four prevalent symptoms. Subgroups of patients differ in functional status and quality of life as a result of symptom severity.

Implications for Nursing: Clinicians should assess and identify patients with severe levels of the four prevalent symptoms and offer appropriate interventions. Future study is needed to investigate the factors that contribute to symptom severity and to examine the occurrence of symptom clusters that may place patients at increased risk for poorer outcomes.

Jump to a section


    Barsevick, A. M. (2007). The concept of symptom cluster. Seminars in Oncology Nursing, 23, 89-98. doi: S0749-2081(07)00019-8
    Beck, S. L., Dudley, W. N., & Barsevick, A. (2005). Pain, sleep disturbance, and fatigue in patients with cancer: Using a mediation model to test a symptom cluster. Oncology Nursing Forum, 32, E48-E55.
    Chen, M. L., & Tseng, H. C. (2006). Symptom clusters in cancer patients. Supportive Care in Cancer, 14, 825-830. doi: 10.1007/s00520-006-0019-8
    Chow, E., Fan, G., Hadi, S., Wong, J., Kirou-Mauro, A., & Filipczak, L. (2008). Symptom clusters in cancer patients with brain metastases. Clinical Oncology (Royal College of Radiologists), 20, 76-82.
    Cleeland, C. S., Mendoza, T. R., Wang, X. S., Chou, C., Harle, M. T., Morrissey, M., … Engstrom, M. C. (2000). Assessing symptom distress in cancer patients. Cancer, 89, 1634-1646.
    Clogg, C. (1988). Latent class models for measuring. In R. Langeheine & J. Rost (Eds.), Latent trait and latent class models (pp. 173-205). New York, NY: Springer.
    Dibble, S. L., Padilla, G. V., Dodd, M. J., & Miaskowski, C. (1998). Gender differences in the dimensions of quality of life. Oncology Nursing Forum, 25, 577-583.
    Dodd, M. J. (1988). Patterns of self-care in patients with breast cancer. Western Journal of Nursing Research, 10, 7-24.
    Dodd, M. J., Cho, M. H., Cooper, B. A., & Miaskowski, C. (2009). The effect of symptom clusters on functional status and quality of life in women with breast cancer. European Journal of Oncology Nursing, 14, 101-110. doi: 10.1016/j.ejon.2009.09.005
    Dodd, M. J., Dibble, S., Miaskowski, C., Paul, S., Cho, M., MacPhail, L., … Shiba, G. (2001). A comparison of the affective state and quality of life of chemotherapy patients who do and do not develop chemotherapy-induced oral mucositis. Journal of Pain and Symptom Management, 21, 498-505. doi: S0885392401002779
    Dodd, M. J., Miaskowski, C., & Paul, S. M. (2001). Symptom clusters and their effect on the functional status of patients with cancer. Oncology Nursing Forum, 28, 465-470.
    Eysenbach, G. T. (2005). The impact of the Internet on cancer outcomes. CA: A Cancer Journal for Clinicians, 53, 356-371.
    Ferrell, B. R., Wisdom, C., & Wenzl, C. (1989). Quality of life as an outcome variable in the management of cancer pain. Cancer, 63(11, Suppl.), 2321-2327.
    Fox, S. W., Lyon, D., & Farace, E. (2007). Symptom clusters in patients with high-grade glioma. Journal of Nursing Scholarship, 39, 61-67.
    Gift, A. G., Jablonski, A., Stommel, M., & Given, C. W. (2004). Symptom clusters in elderly patients with lung cancer. Oncology Nursing Forum, 31, 202-212. doi: 10.1188/04.ONF.203-212
    Gift, A. G., Stommel, M., Jablonski, A., & Given, W. (2003). A cluster of symptoms over time in patients with lung cancer. Nursing Research, 52, 393-400. doi: 10.1097/00006199-200311000-00007
    Gleason, J. F., Jr., Case, D., Rapp, S. R., Ip, E., Naughton, M., Butler, J. M., Jr., … Shaw, E. G. (2007). Symptom clusters in patients with newly-diagnosed brain tumors. Journal of Supportive Oncology, 5, 427-433, 436.
    Guyatt, G. H., Osoba, D., Wu, A. W., Wyrwich, K. W., & Norman, G. R. (2002). Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings, 77, 371-383. doi: 10.4065/77.4.371
    Hyde, L. K., Wolf, J., McCracken, S., & Yesner, M. (1973). Natural course of inoperable lung cancer. Chest, 64, 309-312.
    Im, E., & Chee, W. (2004a). Issues in Internet survey research among cancer patients. Cancer Nursing, 27, 34-42.
    Im, E., & Chee, W. (2004b). Recruitment of research participants through the internet. CIN: Computers, Informatics, 22, 289-297.
    Jensen, M. P. (2003). The validity and reliability of pain measures in adults with cancer. Journal of Pain and Symptom Management, 4, 2-21.
    Karnofsky, D. (1977). Performance scale. In G. T. Kennealey & M. S. Mitchell (Eds.), Factors that influence the therapeutic response in cancer: A comprehensive treatise (pp. 97-101). New York, NY: Plenum Press.
    Kim, E., Jahan, T., Aouizerat, B. E., Dodd, M. J., Cooper, B. A., Paul, S. M., … Miaskowski, C. (2009). Changes in symptom clusters in patients undergoing radiation therapy. Supportive Care in Cancer, 17, 1383-1391.
    Kim, H. J., Barsevick, A. M., Tulman, L., & McDermott, P. A. (2008). Treatment-related symptom clusters in breast cancer: A secondary analysis. Journal of Pain and Symptom Management, 36, 468-479.
    Lee, K. A. (1992). Self-reported sleep disturbances in employed women. Sleep, 15, 493-498.
    Lee, K. A., & DeJoseph, J. F. (1992). Sleep disturbances, vitality, and fatigue among a select group of employed childbearing women. Birth: Issues in Perinatal Care, 19(4), 208-213.
    Lee, K. A., & Gay, C. L. (2004). Sleep in late pregnancy predicts length of labor and type of delivery. American Journal of Obstetrics and Gynecology, 191, 2041-2046. doi: 10.1016/j.ajog.2004.05.086
    Lee, K. A., Portillo, C. J., & Miramontes, H. (1999). The fatigue experience for women with human immunodeficiency virus. Journal of Obstetric, Gynecologic, and Neonatal Nursing, 28, 193-200.
    Miaskowski, C., Cooper, B. A., Paul, S. M., Dodd, M., Lee, K., Aouizerat, B. E., … Bank, K. A. (2006). Subgroups of patients with cancer with different symptom experiences and quality-of-life outcomes: A cluster analysis [Online exclusive]. Oncology Nursing Forum, 33, E79-E89.
    Miaskowski, C., Dodd, M., & Lee, K. (2004). Symptom clusters: The new frontier in symptom management research. Journal of the National Cancer Institute. Monographs, 32, 17-21.
    Miaskowski, C., & Lee, K. A. (1999). Pain, fatigue, and sleep disturbances in oncology outpatients receiving radiation therapy for bone metastasis: A pilot study. Journal of Pain and Symptom Management, 17, 320-332. doi: 10.1016/S0885-3924(99)00008-1
    Mor, V., Laliberte, L., Morris, J. N., & Wiemann, M. (1984). The Karnofsky Performance Status Scale. An examination of its reliability and validity in a research setting. Cancer, 53, 2002-2007.
    National Cancer Institute. (2009). Dictionary of cancer terms: Biological therapy. Retrieved from
    Norman, G. R., Sloan, J. A., & Wyrwich, K. W. (2003). Interpretation of changes in health-related quality of life: The remarkable universality of half a standard deviation. Medical Care, 41, 582-592.
    Nylund, K., Asparouhov, T., & Muthén, B. (2007). Deciding on the number of classes in latent class analysis and growth mixture modeling: A Monte Carlo simulation study. Structural Equation Modeling, 14, 535-569.
    Nylund, K., Bellmore, A., Nishina, A., & Graham, S. (2007). Subtypes, severity, and structural stability of peer victimization: What does latent class analysis say? Child Development, 78, 1706-1722.
    Osoba, D., Rodrigues, G., Myles, J., Zee, B., & Pater, J. (1998). Interpreting the significance of changes in health-related quality-of-life scores. Journal of Clinical Oncology, 16, 139-144.
    Pinar, R. (2004). Reliability and validity of the Turkish version of Multidimensional Quality of Life Scale—Cancer version 2 in patients with cancer. Cancer Nursing, 27(3), 252-257.
    Piper, B. F., Dibble, S. L., Dodd, M. J., Weiss, M. C., Slaughter, R. E., & Paul, S. M. (1998). The revised Piper Fatigue Scale: Psychometric evaluation in women with breast cancer. Oncology Nursing Forum, 25, 677-684.
    Pud, D., Ben Ami, S., Cooper, B. A., Aouizerat, B. E., Cohen, D., Radiano, R., … Miaskowski, C. (2008). The symptom experience of oncology outpatients has a different impact on quality-of-life outcomes. Journal of Pain and Symptom Management, 35, 162-170.
    Radloff, L. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385-401. doi: 10.1177/014662167700100306
    Schag, C., Heinrich, R., & Ganz, P. (1984). Karnofsky performance status revisited. Journal of Clinical Oncology, 2, 187-193.
    Sloan, J. A., Frost, M. H., Berzon, R., Dueck, A., Guyatt, G., Moinpour, C., … Cella, D. (2006). The clinical significance of quality of life assessments in oncology: A summary for clinicians. Supportive Care in Cancer, 14, 988-998. doi: 10.1007/s00520-006-0085-y
    Sloan, J. A., Vargas-Chanes, D., Kamath, C. C., Sargent, D. J., Novotny, P., Atherton, P., … Loprinzi, C. L. (2003). Detecting worms, ducks, and elephants: A simple approach for defining clinically relevant effects in quality-of-life measures. Journal of Cancer Integrative Medicine, 1, 41-47.
    Tseng, T. H., Cleeland, C. S., Wang, X. S., & Lin, C. C. (2008). Assessing cancer symptoms in adolescents with cancer using the Taiwanese version of the M. D. Anderson Symptom Inventory [Online exclusive]. Cancer Nursing, 31, E9-E16.
    Wang, S. Y., Tsai, C. M., Chen, B. C., Lin, C. H., & Lin, C. C. (2008). Symptom clusters and relationships to symptom interference with daily life in Taiwanese lung cancer patients. Journal of Pain and Symptom Management, 35, 258-266. doi: S0885-3924(07)00676-8
    Wang, X. S., Laudico, A. V., Guo, H., Mendoza, T. R., Matsuda, M. L., Yosuico, V. D., … Cleeland, C. S. (2006). Filipino version of the M. D. Anderson Symptom Inventory: Validation and multisymptom measurement in cancer patients. Journal of Pain and Symptom Management, 31, 542-552. doi: 10.1016/j.jpainsymman.2005.11.011
    Wang, X. S., Tang, J. Y., Zhao, M., Guo, H., Mendoza, T., & Cleeland, C. S. (2003). Pediatric cancer pain management practices and attitudes in China. Journal of Pain and Symptom Management, 26, 748-759.
    Winningham, M. (1998). The effects of aerobic exercise on patient reports of nausea. Oncology Nursing Forum, 15, 447-450.
    Young-McCaughan, S., & Sexton, D. (1991). A retrospective investigation of the relationship between aerobic exercise and quality of life in women with breast cancer. Oncology Nursing Forum, 18, 751-757.