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The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: Baseline findings, methodological challenges, and solutions

Published online by Cambridge University Press:  13 February 2009

Marie Bakitas ,
Kathleen Doyle Lyons ,
Mark T. Hegel ,
Stefan Balan ,
Kathleen N. Barnett ,
Frances C. Brokaw ,
Ira R. Byock ,
Jay G. Hull ,
Zhongze Li  and
Elizabeth Mckinstry
...Show all authors
Marie Bakitas*
Affiliation:
Department of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire School of Nursing, Yale University, New Haven, Connecticut
Kathleen Doyle Lyons
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Mark T. Hegel
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Stefan Balan
Affiliation:
White River Junction, Veterans Administration Medical Center, White River Junction, Vermont
Kathleen N. Barnett
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Frances C. Brokaw
Affiliation:
Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire Department of Medicine, Dartmouth Medical School, Hanover, New Hampshire, USA
Ira R. Byock
Affiliation:
Department of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
Jay G. Hull
Affiliation:
Dartmouth College, Hanover, New Hampshire
Zhongze Li
Affiliation:
Biostatistics Shared Resource, Norris Cotton Cancer Center, Dartmouth College, Hanover, New Hampshire
Elizabeth Mckinstry
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Janette L. Seville
Affiliation:
Department of Psychiatry, Dartmouth Medical School, Hanover, New Hampshire
Tim A. Ahles
Affiliation:
Department of Psychiatry, Memorial Sloan-Kettering Cancer Center, New York, New York
*
Address correspondence and reprint requests to: Marie Bakitas, Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756. E-mail: marie.bakitas@dartmouth.edu
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Abstract

Objective:

There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues.

Methods:

Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death.

Results:

Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and “usual care” control group contamination are described.

Significance of results:

It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.

Keywords

Palliative CareRandomized Controlled TrialAdvanced CancerMethodological IssuesIntervention StudyRural
Type
Original Articles
Information
Palliative & Supportive Care , Volume 7 , Issue 1 , March 2009 , pp. 75 - 86
Copyright
Copyright © Cambridge University Press 2009

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References

REFERENCES

Administration on Aging, U.S. Department of Health and Human Services. (2006). A Profile of Older Americans: 2006: Ages 65 +. Washington DC: Author. Available at http://www.aoa.dhhs.gov/prof/Statistics/profile/2006/2006profile.pdf.Google Scholar
American Cancer Society. (2007). Cancer Facts and Figures 2007. Atlanta, GA: American Cancer Society.Google Scholar
Bakitas, M., Ahles, T., Skalla, K., et al. (2008). Proxy perspectives on end-of-life care. Cancer, 112, 1854–1861.CrossRefGoogle ScholarPubMed
Bakitas, M., Lyons, K.D., Dixon, J., et al. (2006). Palliative Care Program Effectiveness Research: Developing rigor in sampling design, conduct and reporting. Journal of Pain and Symptom Management, 31, 270–284.CrossRefGoogle ScholarPubMed
Bakitas, M., Stevens, M., Ahles, T., et al. (2004). Project ENABLE: A palliative care demonstration project for advanced cancer patients in three settings. Journal of Palliative Medicine, 7, 363–372.CrossRefGoogle ScholarPubMed
Brady, M.J., Cella, D.F., Mo, F., et al. (1997). Reliability and validity of the functional assessment of cancer therapy—Breast Quality-of-Life instrument. Journal of Clinical Oncology, 15, 974–986.CrossRefGoogle ScholarPubMed
Bruera, E. (1996). Assessing quality of life in palliative care. Cancer Treatment and Research, 100, 3–12.Google Scholar
Bruera, E., Kuehn, N., Miller, M.J., et al. (1991). The Edmonton Symptom Assessment System (ESAS): A simple method for the assessment of palliative care patients. Journal of Palliative Care, 7, 6–9.CrossRefGoogle ScholarPubMed
Buccheri, G., Ferrigno, D., & Tamburini, M. (1996). Karnofsky and ECOG performance status scoring in lung cancer: A prospective, longitudinal study of 536 patients from a single institution. European Journal of Cancer, 32A, 1135–1141.CrossRefGoogle ScholarPubMed
Byock, I. (2000). Completing the continuum of cancer care: Integrating life-prolongation and palliation. CA: a Cancer Journal for Clinicians, 50, 123–132.Google ScholarPubMed
Byock, I., Twohig, J.S., Merriman, M., et al. (2006). Promoting excellence in end-of-life care: A report on innovative models of palliative care. Journal of Palliative Medicine, 9, 137–151.CrossRefGoogle ScholarPubMed
Cella, D.F., Tulsky, D.S., Gray, G., et al. (1993). The Functional Assessment of Cancer Therapy Scale: Development and validation of the general measure. Journal of Clinical Oncology, 11, 570–579.CrossRefGoogle ScholarPubMed
Chang, V.T., Hwang, S.S., & Feuerman, M. (2000). Validation of the Edmonton Symptom Assessment Scale. Cancer, 88, 2164–2171.3.0.CO;2-5>CrossRefGoogle ScholarPubMed
Conn, V.S., Cooper, P.S., Ruppar, T.M., et al. (2008). Searching for the intervention in intervention research reports. Journal of Nursing Scholarship, 40, 52–59.CrossRefGoogle ScholarPubMed
Cook, A.M., Finlay, I.G., & Butler-Keating, R.J. (2002). Recruiting into palliative care trials: Lessons learnt from a feasibility study. Palliative Medicine, 16, 163–165.CrossRefGoogle ScholarPubMed
Currow, D.C., Abernethy, A.P., Shelby-James, T.M., et al. (2006). The impact of conducting a regional palliative care clinical study. Palliative Medicine, 20, 735–743.CrossRefGoogle ScholarPubMed
Davies, B., Chekryn Reimer, J., Brown, P., et al. (1995). Challenges of conducting research in palliative care. Omega, 31, 263–273.CrossRefGoogle ScholarPubMed
Dean, R.A., & McClement, S.E. (2002). Palliative care research: Methodological and ethical challenges. International Journal of Palliative Nursing, 8, 376–380.CrossRefGoogle ScholarPubMed
Ewing, G., Rogers, M., Barclay, S., et al. (2004). Recruiting patients into a primary care based study of palliative care: Why is it so difficult? Palliative Medicine, 18, 452–459.CrossRefGoogle ScholarPubMed
Ferguson, R. (2003). Group Shared Medical Appointments (SMAs) for Project Enable II: Facilitator Training Manual. Lebanon, NH: Dartmouth-Hitchcock Medical Center.Google Scholar
Field, M.J., & Cassel, C.K. (1997). Approaching Death: Improving Care at the End of Life. Washington, DC: National Academy Press.Google Scholar
Foley, K.M., & Gelband, H. (2001). Improving Palliative Care for Cancer. Washington, DC: Institute of Medicine and National Research Council.Google Scholar
Given, B.A., Given, C.W., & Stommel, M. (2002). Depression and functional status as predictors of death among cancer patients. Cancer, 94, 2719–2727.Google Scholar
Grande, G. (2000). Why are trials in palliative care so difficult? Palliative Medicine, 14, 69–74.CrossRefGoogle ScholarPubMed
Hegel, M., Barrett, J., & Oxman, T. (2000). Training therapists in problem-solving treatment of depressive disorders in primary care: Lessons learned from the “treatment effectiveness project.” Family Systems & Health, 18, 359–407.CrossRefGoogle Scholar
Hinds, P.S., Burghen, E.A., & Pritchard, M. (2007). Conducting end-of-life studies in pediatric oncology. Western Journal of Nursing Research, 29, 448–465.CrossRefGoogle ScholarPubMed
Holzner, B., Kemmler, G., Cella, D., et al. (2004). Normative data for functional assessment of cancer therapy—general scale and its use for the interpretation of quality of life scores in cancer survivors. Acta Oncologica, 43, 153–160.CrossRefGoogle ScholarPubMed
Hopkinson, J.B., Wright, D.N., & Corner, J.L. (2005). Seeking new methodology for palliative care research: Challenging assumptions about studying people who are approaching the end of life. Palliative Medicine, 19, 532–537.CrossRefGoogle ScholarPubMed
Hudson, P., Aranda, S., & McMurray, N. (2001). Randomized controlled trials in palliative care: Overcoming the obstacles. International Journal of Palliative Nursing, 7, 427–434.CrossRefGoogle ScholarPubMed
Jordhoy, M.S., Kaasa, S., Fayers, P.M., et al. (1999). Challenges in palliative care research; recruitment, attrition and compliance: Experience from a randomized controlled trial. Palliative Medicine, 13, 299–310.CrossRefGoogle ScholarPubMed
Karim, K. (2000). Conducting research involving palliative patients. Nursing Standard, 15, 34–36.Google ScholarPubMed
Karnofsky, D. & Burchenal, J. (1949). The clinical evaluation of chemotherapeutic agents in cancer. In Evaluation of Chemotherapeutic Agents, MacLeod, C. (Ed.), pp. 199–205. New York: Columbia University Press.Google Scholar
Krouse, R.S., Rosenfeld, K.E., Grant, M., et al. (2004). Palliative care research: Issues and opportunities. Cancer Epidemiology, Biomarkers & Prevention, 13, 337–339.CrossRefGoogle ScholarPubMed
Lassauniere, J. & Vinant, P. (1992). Prognostic factors, survival, and advanced cancer. Journal of Palliative Care, 8, 52–54.CrossRefGoogle ScholarPubMed
Lynn, J. & Adamson, D. (2003). Living Well at the End of Life: Adapting Health Care to Serious Chronic Illness in Old Age. Santa Monica, CA: Rand Corp.Google Scholar
Lyons, K.D., Bakitas, M., Hegel, M.T., et al. (2009). Reliability and validity of the functional assessment of chronic illness therapy-palliative care (FACIT-Pal) Scale. Journal of Pain & Symptom Management, 37, 23–32.CrossRefGoogle ScholarPubMed
Mazzocato, C., Sweeney, C., & Bruera, E. (2001). Clinical research in palliative care: Patient populations, symptoms, interventions and endpoints. Palliative Medicine, 15, 163–168.CrossRefGoogle ScholarPubMed
McMillan, S.C., Small, B.J., Weitzsner, M.A., et al. (2005). Impact of coping skills intervention with family caregivers of hospitce patients with cancer: A randomized clinical trial. Cancer, 106, 214–222.CrossRefGoogle Scholar
McMillan, S.C. & Weitzsner, M.A. (2003). Methodologic issues in collecting data from debilitated patients with cancer near the end of life. Oncology Nursing Forum, 30, 123–129.CrossRefGoogle ScholarPubMed
McQuay, H. & Moore, A. (1994). Need for rigorous assessment of palliative care. British Medical Journal, 309, 1315–1316.CrossRefGoogle ScholarPubMed
McWhinney, I., Bass, M., & Donner, A. (1994). Evaluation of a palliative care service: Problems and pitfalls. British Medical Journal, 309, 1340–1342.CrossRefGoogle ScholarPubMed
Meyers, F. & Linder, J. (2003). Simultaneous care: Disease treatment and palliative care throughout illness. Journal of Clinical Oncology, 21, 1412–1415.CrossRefGoogle ScholarPubMed
Morgan, D.L. (1998). Practical strategies for combining qualitative and quantitative methods: Applications to health research. Qualitative Health Research, 8, 362–376.CrossRefGoogle ScholarPubMed
Mularski, R.A., Rosenfeld, K., Coons, S., et al. (2007). Measuring outcomes in randomized prospective trials in palliative care. Journal of Pain & Symptom Management, 34, S7–S19.CrossRefGoogle ScholarPubMed
National Comprehensive Cancer Network. (2006). Palliative Care V.I.2006, NCCN Clinical Practice Guidelines in Oncology. New York: National Comprehensive Cancer Network.Google Scholar
Noffsinger, E. (2000). Understanding today's group visit models. Group Practice Journal, 49, 46–58.Google Scholar
Northouse, L.L., Rosset, T., Phillips, L., et al. (2006). Research with families facing cancer: The challenges of accrual and retention. Research in Nursing and Health, 29, 199–211.CrossRefGoogle ScholarPubMed
Okun, A., Stein, R., Buman, L., et al. (1996). Content validity of the Psychiatric Symptom Index, CES-depression Scale, and State-Trait Anxiety Inventory from the perspective of DSM-IV. Psychological Reports, 79, 1059–1069.CrossRefGoogle ScholarPubMed
Oxenham, D. (1998). Accuracy of prediction of survival by different professional groups in a hospice. Palliative Medicine, 12, 117–118.CrossRefGoogle Scholar
Pickering, R.M. (2002). Statistical aspects of measurement in palliative care. Palliative Medicine, 16, 359–364.CrossRefGoogle ScholarPubMed
Pitorak, E., Armour, M., & Sivec, H. (2003). Project Safe Conduct integrates palliative goals into comprehensive cancer center. Journal of Palliative Medicine, 6, 645–655.CrossRefGoogle Scholar
Radloff, L. (1977). The CES-D Scale: A self report depression scale for research in the general population. Applied Psychological Measurement, 1, 385–401.CrossRefGoogle Scholar
Rinck, G., van den Bos, G., Kleijnen, J., et al. (1997). Methodologic issues in effectiveness research on palliative cancer care: A systematic review. Journal of Clinical Oncology, 15, 1697–1707.CrossRefGoogle ScholarPubMed
Roberts, R. & Vernon, S. (1983). The Center for Epidemiologic Studies Depression Scale: Its use in a community sample. American Journal of Psychiatry, 140, 41–46.Google Scholar
Roth, A.J., Kornblith, A.B., Batel-Copel, L., et al. (1998). Rapid screening for psychologic distress in men with prostate carcinoma. Cancer, 82, 1904–1908.3.0.CO;2-X>CrossRefGoogle ScholarPubMed
Sandelowski, M. (1996). Using qualitative methods in intervention studies. Research in Nursing and Health, 19, 359–364.3.0.CO;2-H>CrossRefGoogle ScholarPubMed
Schag, C.C., Heinrich, R.L., & Ganz, P.A. (1984). Karnofsky performance status revisited: Reliability, validity, and guidelines. Journal of Clinical Oncology, 2, 187–193.CrossRefGoogle ScholarPubMed
Sepulveda, C., Yoshida, A., & Ullrich, T. (2002). Palliative care: The World Health Organization's global perspective. Journal of Pain & Symptom Management, 24, 91–96.CrossRefGoogle ScholarPubMed
Shadish, W., Cook, T.D., & Campbell, D.T. (2002). Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Boston: Houghton Mifflin.Google Scholar
Singer, J. & Willett, J. (2003). Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press.CrossRefGoogle Scholar
Skalla, K., Bakitas, M., Furstenberg, C., et al. (2004). Patients' need for information about cancer therapy. Oncology Nursing Forum, 31, 313–320.CrossRefGoogle ScholarPubMed
Steinhauser, K.E., Clipp, E.C., Hays, J.C., et al. (2006). Identifying, recruiting, and retaining seriously ill patients and their caregivers in longitudinal research. Palliative Medicine, 20, 745–754.CrossRefGoogle ScholarPubMed
Temel, J., Jackson, V., Billings, A., et al. (2007). Phase II Study: Integrated palliative care in newly diagnosed advanced non-small cell lung cancer patients. Journal of Clinical Oncology, 25, 2377–2382.CrossRefGoogle ScholarPubMed
Teno, J.M. (2001). Quality of care and quality indicators for end-of-life cancer care: Hope for the best, yet prepare for the worst. In Improving Palliative Care for Cancer, Foley, K.M. & Gelband, H. (Eds.), pp. 96–131. Washington, DC: National Academy Press.Google Scholar
Washington State Department of Health (2006). Guidelines for using rural-urban classification systems for public health assessment. Retrieved May 16, 2007, from http://www.doh.wa.gov/Data/Guidelines/RuralUrban.htm.Google Scholar
Whedon, M. (2001). Revisiting the road not taken: Integrating palliative care into oncology nursing. Clinical Journal of Oncology Nursing, 6, 27–33.CrossRefGoogle Scholar
World Health Organization. (2003). Palliative care: What is it. Retrieved December, 2005, from www.who.org.Google Scholar
Zimmermann, C., Riechelmann, R., Krzyzanowska, M., et al. (2008). Effectiveness of specialized palliative care: A systematic review. JAMA, 299, 1698–1709.CrossRefGoogle ScholarPubMed