1. The Influence of Comorbidities on Use of Symptom Management Strategies in a Cancer Patient Intervention Gerontological Society of America November 19, 2011 Sandra L. Spoelstra, PhD, RN

2. Acknowledgements The data for the secondary analysis came from: NCI Family Home Care for Cancer: A Community-Based Model PI B. Given (RO-1 CA79280) NCI Automated Telephone Monitoring for Symptom Management PI C. Given (RO-1 CA-30724) This research was also supported by:  The State of Michigan Nurse Corp Fellowship  The Mary Margaret Walther Behavioral Oncology Group Fellowship Mentors: Drs. Barbara and Charles W. Given 2

3. Background & Significance 75% of those with cancer also have another chronic condition. Patients’ undergoing chemotherapy are often managing multiple chronic conditions, and the cancer treatment often adds the burden of new or intensified symptoms. Koroukian SM, Murray P, Madigan E. Comorbidity, disability, and geriatric syndromes in elderly cancer patients receiving home health care. Journal of Clinical Oncology. 2006; 24(15): 2304-10. Ogle KS, Swanson GM, Woods N, et al. Cancer and comorbidity. Cancer. 2000; 8: 653-63. Smith AW, Reeve BB, Bellizzi KM, Harlan LC, Klabunde CN, Amsellem M, et al. Cancer, comorbidities, and health-related quality of life of older adults. Health Care Financing Review. 2008; 29(4): 41-56. 3

4. Purpose To examine the impact of comorbidities on symptoms and use of symptom strategies in cancer patients undergoing chemotherapy. 4

5. Research Questions 1.Is there difference in number of comorbid conditions by age? 2.How do the number of comorbid conditions relate to number of symptoms above threshold? (age adjusted) 3.How do the number of comorbid conditions relate to the proportion of symptom responses? (change from severe to moderate/mild or moderate to mild by total number of symptoms above threshold [adjusted by age]) 4. How do different levels of comorbid condition relate to baseline symptom severity and responses to strategies to improve symptoms in pain, fatigue, weakness, & insomnia? 5

6. The Intervention Patient were enrolled and provided a Symptom Management Toolkit which included tips on how to manage the 15 most common cancer symptoms. Patients were followed for 10 weeks, a baseline interview, 8 weekly assessments, and an exit interview. An Automated Voice Response system was used to assess symptom severity and to direct patients to a symptom toolkit for high symptoms. When needed, an Advanced Practice Nurse provided additional coaching. 6

7. Methodology A secondary data analysis on 463 patients 2 trials that tested the effect of a cognitive behavioral intervention on symptom management –Those undergoing chemotherapy –A solid tumor or non-Hodgkin lymphoma –Age >21 –Cognitively intact –Able to speak and hear English –Access to a touchtone telephone 7

8. Results Mean age 57.3 years 70% Female and 30% Male 85% Caucasian, 9% African American, 6% other 198 breast, 107 lung, 64 colon, 183 other 84% late stage & 6% early stage 24% with a recurrent cancer 8

9. 9 Number of Comorbid Conditions (none to 3 or more)

10. Research Question 1 Is there difference in number of comorbid conditions by age? 10 Number of Comorbid Conditions NMean Age (Standard Deviation) p-value 010749.7 (11.0)Referent 112354.3 (10.9)0.002 212658.0 (10.5)<0.001 3+20762.5 (10.8)<0.001 The number of comorbid conditions increased the older the person: significant difference between 1 versus 2 comorbid conditions (p- value=0.008); 1 versus 3+ (p-value <0.001); 2 versus 3+ (p-value <0.001.)

11. Symptom Thresholds Thresholds are based on cut-points for symptom scores 0—10 labeled as mild, moderate, or severe. Thresholds vary by symptom: Pain & fatigue 0—1 mild, 2—4 moderate, 5—1 severe. Weakness& insomnia 0—2 mild, 3—4 moderate, 5—10 severe. Moderate and severe are ‘above threshold’. Sikorskii et al. “Response analysis for multiple symptoms revealed differences between arms of a symptom management trial. Journal of Clinical Epidemiology 62 (2009) pages 716-724. 11

12. Research Question 2 How do the number of comorbid conditions relate to number of symptoms above threshold? (adjusted by age) 12 Number of Comorbid Conditions Least Squares Mean of Symptoms Above Threshold Standard ErrorP-value 05.520.30Referent 16.090.280.15 26.440.270.02 3+7.530.22<0.0001 More symptoms above threshold were found in those with more comorbid conditions (age adjusted): significant differences between: 1 versus 3+ (p- value <0.0001); and 2 versus 3+ (p-value=0.0012).

13. We did not find that increasing number of comorbid conditions (0—3+) had any impact on patients trying symptom management strategies during the 2 trials. 13

14. Research Question 3 How do the do the number of comorbid conditions relate to the proportion of symptom responses? 14 Number of Comorbid Conditions Least Squares Mean of Symptoms Above Threshold Standard ErrorP-value 076.72.6Referent 177.52.40.81 276.52.40.95 3+68.61.90.14 Those with the 3+ comorbid conditions had the least improvement in symptoms found between: 1 versus 3+ (p=0.004); and 2 versus 3+ (p=0.007).

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16. Results To understand this further we examined how do different levels of comorbid condition related to baseline symptom severity and responses to strategies to improve symptoms in the 4 most commonly occurring symptom. –Fatigue 93% N=512 –Weakness 60% N=329 –Pain 54% N=296 –Insomnia 49% N=273 16

17. Research Question 4: Fatigue 17 Number of Comorbid Conditions (N) Baseline Symptom Severity N (%) Symptom ResponseLast Contact Symptom Severity Total N (%)Onset N (%)Moderate N (%) Severe N (%) 0 (N=96) Severe: 50 (52%)61 (64%)38 (76%)24 (63%)14 (37%) Moderate: 46 (48%)23 (50%)-23 (100%) 1 (N=101)Severe: 62 (61%)69 (68%)49 (79%)34 (69%)15 (31%) Moderate: 39 (39%)20 (51%)-20 (100%) 2 (N=119)Severe: 63 (53%)73 (61%)45 (71%)32 (71%)13 (28%) Moderate: 56 (47%)28 (50%)-28 (100%) 3+ (N=196)Severe: 130 (66%)94 (48%)70 (54%)24 (34%)46 (66%) Moderate: 66 (34%)24 (60%)-24 (100%)

18. Research Question 4: Weakness 18 Number of Comorbid Conditions (N) Baseline Symptom Severity N (%) Symptom ResponseLast Contact Symptom Severity Total N (%)Onset N (%)Moderate N (%) Severe N (%) 0 (N=54) Severe: 28 (52%)46 (85%)25 (89%)5 (20%)20 (80%) Moderate: 26 (48%)21 (80%)-21 (100%) 1 (N=59)Severe: 30 (51%)40 (68%)20 (67%)6 (30%)14 (70%) Moderate: 29 (49%)20 (69%)-20 (100%) 2 (N=78)Severe: 44 (56%)60 (77%)34 (77%)6 (18%)28 (82%) Moderate: 34 (44%)26 (76%)-28 (100%) 3+ (N=136)Severe: 84 (62%)85 (63%)51 (61%)21 (41%)30 (59%) Moderate: 52 (38%)34 (66%)-34 (100%)

19. Research Question 4: Pain 19 Number of Comorbid Conditions (N) Baseline Symptom Severity N (%) Symptom ResponseLast Contact Symptom Severity Total N (%)Onset N (%)Moderate N (%) Severe N (%) 0 (N=53) Severe: 16 (30%)41 (77%)11 (69%)6 (55%)5 (45%) Moderate: 37 (70%)30 (81%)-30 (100%) 1 (N=54)Severe: 25 (46%)40 (74%)19 (76%)6 (32%)13 (68%) Moderate: 29 (54%)21 (72%)-21 (100%) 2 (N=67)Severe: 30 (45%)48 (72%)20 (67%)9 (45%)11 (55%) Moderate: 37 (55%)28 (76%)-28 (100%) 3+ (N=122)Severe: 64 (52%)78 (64%)43 (67%)24 (31%)19 (24%) Moderate: 58 (43%)35 (60%)-35 (100%)

20. Research Question 4: Insomnia 20 Number of Comorbid Conditions (N) Baseline Symptom Severity N (%) Symptom ResponseLast Contact Symptom Severity Total N (%)Onset N (%)Moderate N (%) Severe N (%) 0 (N=57) Severe: 10 (18%)49 (86%)10 (100%)4 (40%)6 (60%) Moderate: 47 (82%)39 (83%)-39 (100%) 1 (N=47)Severe: 16 (34%)37 (79%)13 (81%)2 (15%)11 (85%) Moderate: 31 (66%)24 (77%)-24 (100%) 2 (N=63)Severe: 21 (33%)47 (75%)19 (90%)2 (4%)17 (36%) Moderate: 42 (67%)28 (67%)-28 (100%) 3+ (N=106)Severe: 43 (41%)74 (72%)33 (77%)13 (39%)19 (61%) Moderate: 61 (59%)41 (67%)41 (100%)

21. Research Question 4: Results Those with 3+ comorbidities had 8% more severe symptoms at onset. At the last intervention contact patients with 3+ comorbidities had: –the highest % of severe symptoms that were lowered to a moderate level of severity; and –the smallest % that moved from severe to mild. 21

22. Summary of Research Findings I.Comorbid conditions increased with age. II.Symptom severity at baseline and over the course of treatment increased in those with comorbid conditions. III.Those with comorbid conditions had more difficulty lowering symptom severity using our intervention during cancer treatment. 22

23. Limitations Generalizabilty is limited as:  We did not know the severity of the comorbid conditions.  Minorities were under-represented. 23

24. Implications for Practice Clinicians need to take comorbid conditions into account during chemotherapy. Symptom severity threshold levels need to be monitored more closed in those with comorbid conditions. Strategies to manage symptoms severity associated cancer treatment needs to be intensified for those with comorbid conditions. 24

25. Implications for Future Research Future trials on symptom management and survivorship need to take into account pre- existing comorbid conditions and their self-care management burden patients bring to their treatment. 25

26. Conclusions Comorbid conditions place extra symptom burden on cancer patients and are associated with lower rates of response to strategies to improve symptoms. 26

27. Thank you.