The Development and Validation of a Measure of Health-Related Quality of Life for Non-Hodgkin’s Lymphoma: The Functional Assessment of Cancer Therapy—Lymphoma (FACT-Lym)
Background. The individual concerns of non-Hodgkin’s lymphoma (NHL) patients require identification and assessment during clinical research proposing to measure patients’ outcomes. The FACT-Lym was developed as part of the FACIT measurement system to address health-related quality-of-life (HRQL) issues for NHL patients. Patients and Methods. Items for the FACT lymphoma subscale (LymS) were generated from healthcare provider interviews, published literature, and content validity patient interviews. The FACT-Lym was validated on a sample of 84 NHL patients, with additional measures at baseline (T1), 3–7 days (T2), and 8–12 weeks (T3). Results. Item correlations, expert relevance ratings, and patient input on content shortened the initial 22-item LymS to 15 items. The validation sample included 56% female, 76.2% white, 60% indolent disease, and 85% receiving treatment. Internal consistency coefficients for the 15-item LymS (.79, .85, and .84 T1–T3) and test-retest stability (.84) indicated good reliability. Correlations between LymS and SF-36 physical ( ) and mental ( ) summary scores reflect concurrent validity. Responsiveness to ECOG performance status and treatment status exceeded established FACT subscale scores. The FACT-LymS differentiated patients’ retrospective ratings of change in each of the three groups (better; unchanged; worse), . Conclusions. These results support the validity of the FACT-Lym and suggest it will be a useful targeted endpoint in NHL clinical research. 1. Introduction Non-Hodgkin’s Lymphoma (NHL) affects approximately 66,000 Americans every year and is the sixth most common cancer among Americans. Five-year survival is better than 60% and 10-year relative survival is over 50% [1]. Significant advances in the clinical management of indolent and aggressive NHL-utilizing cancer therapeutics have improved both response and survival rates for patients thus making it a chronic disease [2, 3]. Autologous and allogeneic stem cell transplantation have shown to improve patient’s outcomes including long-term survival [4–8]. Several treatment options promote disease remission or stability and can minimize side effects such as anemia, mucositis, and myelosuppression [9–12]. Psychological morbidity can also be reduced or managed [13–17]. However, despite improvement in survival and patient management, patients must still endure treatment toxicities with uncertain benefit to any individual treated. The demands of comorbid conditions, psychological distress, and general disease burden must be endured and balanced against treatment efficacy [8,
References
[1]
R. Siegel, E. Ward, O. Brawley, and A. Jemal, “Cancer statistics, 2011,” A Cancer Journal for Clinicians, vol. 61, no. 4, pp. 212–236, 2011.
[2]
B. A. Bilodeau and K. L. Fessele, “Non-Hodgkin's lymphoma,” Seminars in Oncology Nursing, vol. 14, no. 4, pp. 273–283, 1998.
[3]
National Cancer Institute, Non-Hodgkins lymphoma, 2011, http://www.cancer.gov/cancertopics/types/non-hodgkin.
[4]
G. A. Hale and G. L. Phillips, “Allogeneic stem cell transplantation for the non-Hodgkin's lymphomas and Hodgkin's disease,” Cancer Treatment Reviews, vol. 26, no. 6, pp. 411–427, 2000.
[5]
A. Olivieri, D. Capelli, M. Montanari et al., “Very low toxicity and good quality of life in 48 elderly patients autotransplanted for hematological malignancies: a single center experience,” Bone Marrow Transplantation, vol. 27, no. 11, pp. 1189–1195, 2001.
[6]
E. Vellenga, M. van Agthoven, A. J. Croockewit et al., “Autologous peripheral blood stem cell transplantation in patients with relapsed lymphoma results in accelerated haematopoietic reconstitution, improved quality of life and cost reduction compared with bone marrow transplantation: the Hovon 22 study,” British Journal of Haematology, vol. 114, no. 2, pp. 319–326, 2001.
[7]
M. E. McFadden, “Malignant lymphomas,” in Cancer Nursing Principles and Practice, S. L. Groenwald, M. H. Frogge, M. Goodman, and C. H. Yarbro, Eds., pp. 1200–1229, Jones and Bartlett Publishers, Boston, Mass, USA, 3rd edition, 1993.
[8]
M. van Agthoven, E. Vellenga, W. E. Fibbe, T. Kingma, and C. A. Uyl-de Groot, “Cost analysis and quality of life assessment comparing patients undergoing autologous peripheral blood stem cell transplantation or autologous bone marrow transplantation for refractory or relapsed non-Hodgkin's lymphoma or Hodgkin's disease: a prospective randomised trial,” European Journal of Cancer, vol. 37, no. 14, pp. 1781–1789, 2001.
[9]
S. M. Hubbard and D. L. Longo, “Treatment-related morbidity in patients with lymphoma,” Current Opinion in Oncology, vol. 3, no. 5, pp. 852–862, 1991.
[10]
M. S. Kaminski, T. L. Kauf, A. D. Zelenetz, et al., “Treatment of transformed and refractory low-grade lymphoma with Bexxar therapy is associated with improvements in quality of life,” in Proceedings of the Annual Conference of the American Society of Hematology (ASH '01), 2001, abstract no 1790.
[11]
M. Duvic, T. M. Kuzel, E. A. Olsen et al., “Quality-of-life improvements in cutaneous T-cell lymphoma patients treated with Denileukin Diftitox (ONTAK),” Clinical Lymphoma, vol. 2, no. 4, pp. 222–228, 2002.
[12]
A. ？sterborg, Y. Brandberg, V. Molostova et al., “Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin beta, in hematologic malignancies,” Journal of Clinical Oncology, vol. 20, no. 10, pp. 2486–2494, 2002.
[13]
D. Razavi, N. Delvaux, A. Brédart et al., “Professional rehabilitation of lymphoma patients: a study of psychosocial factors associated with return to work,” Supportive Care in Cancer, vol. 1, no. 5, pp. 276–278, 1993.
[14]
F. R. Loberiza Jr., J. D. Rizzo, et al., “Depressive syndrome and early deaths following stem cell transplantation for hematologic disease,” in Proceedings of the Annual Conference of the American Society of Hematology (ASH '01), 2001, abstract no 3091.
[15]
R. Pettengell, C. Donatti, P. Hoskin et al., “The impact of follicular lymphoma on health-related quality of life,” Annals of Oncology, vol. 19, no. 3, pp. 570–576, 2008.
[16]
K. Webster and D. Cella, “Quality of life in patients with low-grade non-Hodgkin's lymphoma,” Oncology, vol. 12, no. 5, pp. 697–714, 1998.
[17]
P. Allart, P. Soubeyran, and F. Cousson-Gélie, “Are psychosocial factors associated with quality of life in patients with haematological cancer? A critical review of the literature,” Psycho-Oncology, 2012.
[18]
J. Fernsler and J. S. Fanuele, “Lymphomas: long-term sequelae and survivorship issues,” Seminars in Oncology Nursing, vol. 14, no. 4, pp. 321–328, 1998.
[19]
L. Lesko, “Hematopoietic dyscrasias,” in Psycho-Oncology, H. C. Holland, Ed., pp. 406–416, Oxford university Press, New York, NY, USA, 1998.
[20]
S. K. Smith, S. Zimmerman, C. S. Williams, et al., “Post-traumatic stress symptoms in long-term non-Hodgkin's lymphoma survivors: does time heal?” Journal of Clinical Oncology, vol. 29, no. 34, pp. 4526–4533, 2011.
[21]
D. Voliotis and V. Diehl, “Challenges in treating hematologic malignancies,” Seminars in Oncology, vol. 29, no. 3, pp. 30–39, 2002.
[22]
T. Foster, J. D. Miller, M. E. Boye, and M. W. Russell, “Economic burden of follicular non-Hodgkin's lymphoma,” Pharmacoeconomics, vol. 27, no. 8, pp. 657–679, 2009.
[23]
S. Orelemans, F. Mols, M. R. Nijziel, et al., “The impact of treatment, socio-demographic and clinical characteristics on health-related quality of life among Hodgkins's and non-Hodgkin's lymphoma survivors, a systemic review,” Annals of Hematology, vol. 90, no. 9, pp. 993–1004, 2011.
[24]
A. Leak, D. K. Mayer, and S. Smith, “Quality of life domains among non-Hodgkin lymphoma survivors: an integrative literature review,” Leukemia & Lymphoma, vol. 52, no. 6, pp. 972–985, 2011.
[25]
E. Deconinck, H. Miadi-Fargier, C. Pen, and P. Brice, “Cost effectiveness of rituximab maintenance therapy in follicular lymphoma: long-term economic evaluation,” Pharmacoeconomics, vol. 28, no. 1, pp. 35–46, 2010.
[26]
F. Kasteng, M. Erlanson, H. Hagberg, E. Kimby, T. Relander, and J. Lundkvist, “Cost-effectiveness of maintenance rituximab treatment after second line therapy in patients with follicular lymphoma in Sweden,” Acta Oncologica, vol. 47, no. 6, pp. 1029–1036, 2008.
[27]
E. J. O. Soini, J. A. Martikainen, and T. Nousiainen, “Treatment of follicular non-Hodgkin's lymphoma with or without rituximab: cost-effectiveness and value of information based on a 5-year follow-up,” Annals of Oncology, vol. 22, no. 5, pp. 1189–1197, 2011.
[28]
N. Martis, C. Gisselbrecht, and N. Mounier, “Quality of life following treatment for B-cell lymphoma,” Expert Review of Pharmacoeconomics & Outcomes Research, vol. 11, no. 5, pp. 523–532, 2011.
[29]
N. A. Barber and F. R. Loberiza Jr., “Quality of life after chemotherapy or hematopoietic cell transplant in follicular lymphoma: what's next?” Leukemia & Lymphoma, vol. 53, no. 3, pp. 352–353, 2012.
[30]
D. Tholstrup, P. D. N. Brown, J. Jurlander, P. Bekker Jeppesen, and M. Groenvold, “Quality of life in patients with diffuse large B-cell lymphoma treated with dose-dense chemotherapy is only affected temporarily,” Leukemia & Lymphoma, vol. 52, no. 3, pp. 400–408, 2011.
[31]
S. K. Smith, C. S. Williams, C. R. Zimmer, and S. Zimmerman, “An exploratory model of the relationships between cancer-related trauma outcomes on quality of life in non-Hodgkin lymphoma survivors,” Journal of Psychosocial Oncology, vol. 29, no. 1, pp. 19–34, 2011.
[32]
K. Yano, T. Kanie, S. Okamoto, et al., “Quality of life in adult patients after stem cell transplantation,” International Journal of Hematology, vol. 71, no. 3, pp. 283–289, 2000.
[33]
A. S. Hamilton, “Quality of life research: adding an important dimension to the evaluation of therapeutic outcomes,” Leukemia & Lymphoma, vol. 52, no. 3, pp. 353–354, 2011.
[34]
K. Webster, J. Cashy, D. Cella, et al., “Measuring quality of life (QOL) in patients with non-Hodgkin's lymphoma (NHL): the functional assessment of cancer therapy-lymphoma (FACT-Lym),” Quality of Life Research, vol. 14, p. 1650, 2005.
[35]
D. Cella, K. Webster, K. Cashy, et al., “Development of a measure of health-related quality of life for non-Hodgkin's lymphoma clinical research: the functional assessment of cancer therapy—lymphoma (FACT-Lym),” Blood, vol. 106, ASH Annual Meeting Abstracts, no. 11, part 1, 750 pages, 2005.
[36]
D. Cella, Ed., Manual of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, Center on Outcomes, Research and Education, Evanston, Ill, USA, 2004.
[37]
D. F. Cella, D. S. Tulsky, G. Gray et al., “The functional assessment of cancer therapy scale: development and validation of the general measure,” Journal of Clinical Oncology, vol. 11, no. 3, pp. 570–579, 1993.
[38]
K. Webster, L. Odom, A. Peterman, et al., “The functional assessment of chronic illness therapy (FACIT) measurement system: validation of version 4 of the core questionnaire,” Quality of Life Research, vol. 8, no. 7, p. 604, 1999.
[39]
D. Cella and C. J. Nowinski, “Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system,” Archives of Physical Medicine and Rehabilitation, vol. 83, no. 12, supplement 2, pp. S10–S17, 2002.
[40]
K. Webster, D. Cella, and K. Yost, “The functional assessment of chronic illness therapy (FACIT) measurement system: properties, applications, and interpretation,” Health and Quality of Life Outcomes, vol. 1, article 79, 2003.
[41]
K. Webster, K. Chivington, C. Shonk, et al., “Measuring quality of life (QOL) among patients with leukemia: the functional assessment of cancer-therapy-leukemia (FACT-Leu),” Quality of Life Research, vol. 11, no. 7, p. 678, 2002.
[42]
C. G. Zubrod, M. Schneiderman, E. Frei et al., “Appraisal of methods for the study of chemotherapy of cancer in man: comparative therapeutic trial of nitrogen mustard and triethylene thiophosphoramide,” Journal of Chronic Diseases, vol. 11, no. 1, pp. 7–33, 1960.
[43]
D. F. Cella, P. B. Jacobsen, and E. J. Orav, “A brief POMS measure of distress for cancer patients,” Journal of Chronic Diseases, vol. 40, no. 10, pp. 939–942, 1987.
[44]
D. P. Crowne and D. Marlowe, “A new scale of social desirability independent of psychopathology,” Journal of Consulting Psychology, vol. 24, no. 4, pp. 349–354, 1960.
[45]
J. E. Ware, K. K. Snow, and M. Kosinski, SF-36 Health Survey: Manual and Interpretation Guide, QualityMetric, Lincoln, Mass, USA, 2000.
[46]
R. Jaeschke, J. Singer, and G. H. Guyatt, “Measurement of health status: ascertaining the minimal clinically important difference,” Controlled Clinical Trials, vol. 10, no. 4, pp. 407–415, 1989.
[47]
L. J. Cronbach, “Coefficient alpha and the internal structure of tests,” Psychometrika, vol. 16, no. 3, pp. 297–334, 1951.
[48]
J. C. Nunnally and I. H. Bernstein, Psychometric Theory, McGraw-Hill, New York, NY, USA, 1994.
[49]
S. Eremenco, K. Webster, L. Kutikova, L. Bowman, and D. Cella, “Development and multilingual validation of the FACT-lymphoma instrument,” Quality of Life Research, vol. 13, no. 9, p. 1501, 2004.
