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Originally published as JCO Early Release 10.1200/JCO.2008.21.4403 on March 2 2009 © 2009 American Society of Clinical Oncology.
In ReplySchool of Social Work, University of Southern California, Los Angeles, CA We thank Patel and Dwamena1 for their interest in our recent clinical trial of depression2 and for the questions they raised, which we are happy to address. On the basis of our prior studies3,4 of underserved populations in safety-net care systems and those of others,5,6 we anticipated relatively high attrition in this trial, including cancer-related deaths. Therefore, we specifically designed the study (ie, projected sample size, recruitment, and attrition reduction and intervention protocols) to facilitate intervention participation and reduce outcome follow-up attrition. Some of these design topics were described in our recent article2 and the study design article.7 We also called attention to the 12-month period in which outcomes in this study2 were reported. There is consistent evidence that trial or treatment attrition can be associated with the length of time for which patients are asked to participate, and this issue can be more formidable among low-income and minority populations.5,6,8,9
Consistent with standard attrition analyses aimed at assessing potential negative effects on randomization,10 we conducted analyses of study data to assess the potential effects of attrition on randomization with respect to similarities and differences in key factors between study groups. We reported analyses comparing baseline demographic and cancer status (acute v follow-up) between patients who remained in the trial and patients lost to follow-up. In the attrition group, there were significantly more non-Hispanics, males, patients older than age 50 years, and patients receiving acute treatment and reporting poorer physical and functional well-being. However, there were no significant differences in rates of mortality and loss to follow-up between intervention (INT) and enhanced usual care (EUC) groups. There were also no significant differences in baseline depression or emotional and social functioning quality-of-life indices between patients lost to follow-up and those who remained in the trial. In conducting the baseline depression comparison, we examined baseline severity of Patient Health Questionnaire–9 (PHQ-9) scores (PHQ-9 score
We appreciate the suggestion of addressing the finding that INT patients were more likely than EUC patients to be foreign born. We conducted an additional analysis controlling for foreign-born status. Results for 50% reduction in PHQ-9 score (odds ratio [OR], 1.91; 95% CI, 1.12 to 3.28; P = .02) and 5-point reduction in PHQ-9 score (OR, 1.96; 95% CI, 1.11 to 3.44; P = .02) were consistent with the findings reported in the original article.2 Among foreign-born patients, the proportion of patients lost to follow-up was 30.1% in the INT group versus 32% in the EUC group at 6 months ( We note that all reported depression and quality-of-life outcome analyses were controlled for covariates, including patient demographics, as reported in the article.2 The 50% reduction in PHQ-9 score at 12-month follow-up occurred in 63% of patients in the INT group and in 50% of patients in the EUC group, with a significant OR of 1.98 (95% CI, 1.16 to 3.38; P = .01), and there was a positive finding of a 5-point decrease in PHQ-9 score. In addition, we reported the results of linear mixed-effect models on continuous PHQ-9 scores and the adjusted mean score difference between INT and EUC groups; we found a positive improvement trend, with an adjusted average PHQ-9 score of 6.4 in the INT group and 7.14 in the EUC group at 12 months (group difference, –0.74; 95% CI, –1.74 to –0.27; P = .15). In view of the strong evidence indicating that the PHQ-9 is a valid diagnostic measure—and because a 50% reduction in PHQ-9 score or 5-point reduction in PHQ-9 score has been found to indicate a diagnostically and clinically meaningful improvement in depression11–18—we concluded that the sociocultural adaptation of the collaborative care model in our study is feasible in this underserved population and results in a clinically significant reduction in depressive symptoms in low-income minority patients with cancer receiving care in a public sector safety-net care system. Our findings are similar to a more recent randomized clinical trial19 conducted in Scotland using a similar collaborative care model, including problem solving therapy for patients with cancer receiving care in the national health service.
With respect to potential effects of cancer status on both depression and quality-of-life outcomes, baseline cancer stage and cancer type were controlled in both logistic regression and linear mixed-effect models evaluating depression and quality-of-life outcomes.2 We conducted an additional analysis to examine cancer status over time; 312 patient records (168 from the INT group and 144 from the EUC group) were obtained and reviewed, excluding those of 68 patients known to have died. At the end of 12 months, 12 patients (four from the INT group and eight from the EUC group) had experienced worsening of cancer status (ie, new cancer, advancing cancer stage, metastasis, or transfer to palliative care). There were no significant differences in cancer status at 12 months between patients of the INT and EUC groups. The rates of patients receiving acute chemotherapy or radiation therapy, maintenance chemotherapy or radiation treatment, and routine follow-up care were evenly distributed between study groups (–3.6%, 1.8%, and 94.6% in the INT group, and 2.1%, 3.5%, and 94.4% in the EUC group, respectively [ Although we experienced significant trial attrition, attrition data analyses support our conclusion about the effectiveness of the tested intervention model in an underserved population likely to encounter significant cultural and socioeconomic barriers in care for both cancer and depression. It has been well established that low-income racial/ethnic minority patients experience disparities in depression care.20 There is now a compelling need to test socioculturally adapted models aimed at reducing these disparities in community-based care systems. We will report our 24-month outcomes as this analysis is completed. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. Acknowledgment Supported by Grant No. R01CA105269 (K.E.) from the National Cancer Institute, Office of Cancer Survivorship, Bethesda, MD. REFERENCES
1. Patel KJ, Dwamena F: Impact of collaborative care management of depression among patients with cancer. J Clin Oncol 27:1730; 2009. 2. Ell K, Xie B, Quon B, et al: Randomized controlled trial of collaborative care management of depression among low-income patients with cancer. J Clin Oncol 26:4488–4496, 2008. 3. Dwight-Johnson M, Ell K, Lee PJ: Can collaborative care address the needs of low-income Latinas with comorbid depression and cancer? Results from a randomized pilot study. Psychosomatics 46:224–232, 2005.[CrossRef][Medline] 4. Ell K, Vourlekis B, Lee PJ, et al: Patient navigation and case management following an abnormal cancer screen: A randomized clinical trial. Prev Med 44:26–33, 2007.[CrossRef][Medline] 5. Miranda J, Chung JY, Green BL, et al: Treating depression in predominantly low-income young minority women: A randomized controlled trial. JAMA 290:57–65, 2003. 6. Miranda J, Green BL, Krupnick JL, et al: One-year outcomes of a randomized clinical trial treating depression in low-income minority women. J Consult Clin Psych 274:99–111, 2006. 7. Ell K, Quon B, Quinn DI, et al: Improving treatment of depression among low-income patients with cancer: The design of the ADAPt-C study. Gen Hosp Psychiatry 29:223–231, 2007.[CrossRef][Medline] 8. Siddiqi AE, Sikorskii A, Given CW, et al: Early participant attrition from clinical trials: Role of trial design and logistics. Clin Trials 5:328–335, 2008. 9. Warden D, Trivedi MH, Wisniewski SR, et al: Predictors of attrition during initial (citalopram) treatment for depression: A STAR*D report. Am J Psychiatry 164:1189–1197, 2007. 10. Evidence-Based Outcome Research: A Practical Guide to Conducting Randomized Controlled Trials for Psychosocial Interventions. Nezu AM, and Nezu CM, Oxford, United Kingdom: Oxford Press, 2008. 11. Löwe B, Kroenke K, Herzog W, et al: Measuring depression outcome with a brief self-report instrument: Sensitivity to change of the Patient Health Questionnaire (PHQ-9). J Affect Disord 81:61–66, 2004.[CrossRef][Medline] 12. Löwe B, Gräfe K, Zipfel S, et al: Diagnosing ICD-10 depressive episodes: Superior criterion validity of the Patient Health Questionnaire. Psychother Psychosom 73:386–390, 2004.[CrossRef][Medline] 13. Löwe B, Unützer J, Callahan CM, et al: Monitoring depression treatment outcomes with the PHQ-9. Med Care 42:1194–1201, 2004.[CrossRef][Medline] 14. Wittkampf KA, Naeije L, Schene AH, et al: Diagnostic accuracy of the mood module of the Patient Health Questionnaire: A systematic review. Gen Hosp Psychiatry 29:388–395, 2007.[CrossRef][Medline] 15. Lee PW, Schulberg HC, Raue PJ, et al: Concordance between the PHQ-9 and the HSCL-20 in depressed primary care patients. J Affect Disord 99:139–145, 2007.[CrossRef][Medline] 16. Löwe B, Schenkel I, Carney-Doebbeling C, et al: Responsiveness of the PHQ-9 to psychopharmacological depression treatment. Psychosomatics 47:62–67, 2006.[CrossRef][Medline] 17. Simon GE, Ludman EJ, Tutty S, et al: Telephone psychotherapy and telephone care management for primary care patients starting antidepressant treatment: A randomized controlled trial. JAMA 292:935–942, 2004. 18. Cameron IM, Crawford JR, Lawton K, et al: Psychometric comparison of PHQ-9 and HADS for measuring depression severity in primary care. Br J Gen Pract 58:32–36, 2008.[CrossRef][Medline] 19. Strong V, Waters R, Hibberd C, et al: Management of depression for people with cancer (SMaRT oncology 1): A randomised trial. Lancet 372:40–48, 2008.[CrossRef][Medline] 20. Alegria M, Chatterji P, Wells K, et al: Disparity in depression treatment among racial and ethnic minority populations in the United States. Psychiatric Serv 59:1264–1272, 2008.
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Copyright © 2009 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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15 v PHQ-9 score < 15) and baseline raw PHQ-9 scores (which were not significant) of patients lost to follow-up and those who remained in the trial. In addition, consistent findings were observed in results of analyses with five imputed data sets. Taken together, the reported results support the validity of our findings. 
2 = 0.16; P = .69), and 38.8% in the INT group versus 46.9% in the EUC group at 12 months (
