Skip to main content
×
Home

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

  • Marie Bakitas (a1) (a2) (a3), Kathleen Doyle Lyons (a4), Mark T. Hegel (a4), Stefan Balan (a5), Kathleen N. Barnett (a4), Frances C. Brokaw (a2) (a6), Ira R. Byock (a1) (a2), Jay G. Hull (a7), Zhongze Li (a8), Elizabeth Mckinstry (a4), Janette L. Seville (a4) and Tim A. Ahles (a9)...
Abstract
ABSTRACTObjective:

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.

Copyright
Corresponding author
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
References
Hide All
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.
American Cancer Society. (2007). Cancer Facts and Figures 2007. Atlanta, GA: American Cancer Society.
Bakitas M., Ahles T., Skalla K., et al. (2008). Proxy perspectives on end-of-life care. Cancer, 112, 18541861.
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, 270284.
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, 363372.
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, 974986.
Bruera E. (1996). Assessing quality of life in palliative care. Cancer Treatment and Research, 100, 312.
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, 69.
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, 11351141.
Byock I. (2000). Completing the continuum of cancer care: Integrating life-prolongation and palliation. CA: a Cancer Journal for Clinicians, 50, 123132.
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, 137151.
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, 570579.
Chang V.T., Hwang S.S., & Feuerman M. (2000). Validation of the Edmonton Symptom Assessment Scale. Cancer, 88, 21642171.
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, 5259.
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, 163165.
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, 735743.
Davies B., Chekryn Reimer J., Brown P., et al. (1995). Challenges of conducting research in palliative care. Omega, 31, 263273.
Dean R.A., & McClement S.E. (2002). Palliative care research: Methodological and ethical challenges. International Journal of Palliative Nursing, 8, 376380.
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, 452459.
Ferguson R. (2003). Group Shared Medical Appointments (SMAs) for Project Enable II: Facilitator Training Manual. Lebanon, NH: Dartmouth-Hitchcock Medical Center.
Field M.J., & Cassel C.K. (1997). Approaching Death: Improving Care at the End of Life. Washington, DC: National Academy Press.
Foley K.M., & Gelband H. (2001). Improving Palliative Care for Cancer. Washington, DC: Institute of Medicine and National Research Council.
Given B.A., Given C.W., & Stommel M. (2002). Depression and functional status as predictors of death among cancer patients. Cancer, 94, 27192727.
Grande G. (2000). Why are trials in palliative care so difficult? Palliative Medicine, 14, 6974.
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, 359407.
Hinds P.S., Burghen E.A., & Pritchard M. (2007). Conducting end-of-life studies in pediatric oncology. Western Journal of Nursing Research, 29, 448465.
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, 153160.
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, 532537.
Hudson P., Aranda S., & McMurray N. (2001). Randomized controlled trials in palliative care: Overcoming the obstacles. International Journal of Palliative Nursing, 7, 427434.
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, 299310.
Karim K. (2000). Conducting research involving palliative patients. Nursing Standard, 15, 3436.
Karnofsky D. & Burchenal J. (1949). The clinical evaluation of chemotherapeutic agents in cancer. In Evaluation of Chemotherapeutic Agents, MacLeod C. (Ed.), pp. 199205. New York: Columbia University Press.
Krouse R.S., Rosenfeld K.E., Grant M., et al. (2004). Palliative care research: Issues and opportunities. Cancer Epidemiology, Biomarkers & Prevention, 13, 337339.
Lassauniere J. & Vinant P. (1992). Prognostic factors, survival, and advanced cancer. Journal of Palliative Care, 8, 5254.
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.
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, 2332.
Mazzocato C., Sweeney C., & Bruera E. (2001). Clinical research in palliative care: Patient populations, symptoms, interventions and endpoints. Palliative Medicine, 15, 163168.
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, 214222.
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, 123129.
McQuay H. & Moore A. (1994). Need for rigorous assessment of palliative care. British Medical Journal, 309, 13151316.
McWhinney I., Bass M., & Donner A. (1994). Evaluation of a palliative care service: Problems and pitfalls. British Medical Journal, 309, 13401342.
Meyers F. & Linder J. (2003). Simultaneous care: Disease treatment and palliative care throughout illness. Journal of Clinical Oncology, 21, 14121415.
Morgan D.L. (1998). Practical strategies for combining qualitative and quantitative methods: Applications to health research. Qualitative Health Research, 8, 362376.
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, S7S19.
National Comprehensive Cancer Network. (2006). Palliative Care V.I.2006, NCCN Clinical Practice Guidelines in Oncology. New York: National Comprehensive Cancer Network.
Noffsinger E. (2000). Understanding today's group visit models. Group Practice Journal, 49, 4658.
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, 199211.
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, 10591069.
Oxenham D. (1998). Accuracy of prediction of survival by different professional groups in a hospice. Palliative Medicine, 12, 117118.
Pickering R.M. (2002). Statistical aspects of measurement in palliative care. Palliative Medicine, 16, 359364.
Pitorak E., Armour M., & Sivec H. (2003). Project Safe Conduct integrates palliative goals into comprehensive cancer center. Journal of Palliative Medicine, 6, 645655.
Radloff L. (1977). The CES-D Scale: A self report depression scale for research in the general population. Applied Psychological Measurement, 1, 385401.
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, 16971707.
Roberts R. & Vernon S. (1983). The Center for Epidemiologic Studies Depression Scale: Its use in a community sample. American Journal of Psychiatry, 140, 4146.
Roth A.J., Kornblith A.B., Batel-Copel L., et al. (1998). Rapid screening for psychologic distress in men with prostate carcinoma. Cancer, 82, 19041908.
Sandelowski M. (1996). Using qualitative methods in intervention studies. Research in Nursing and Health, 19, 359364.
Schag C.C., Heinrich R.L., & Ganz P.A. (1984). Karnofsky performance status revisited: Reliability, validity, and guidelines. Journal of Clinical Oncology, 2, 187193.
Sepulveda C., Yoshida A., & Ullrich T. (2002). Palliative care: The World Health Organization's global perspective. Journal of Pain & Symptom Management, 24, 9196.
Shadish W., Cook T.D., & Campbell D.T. (2002). Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Boston: Houghton Mifflin.
Singer J. & Willett J. (2003). Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press.
Skalla K., Bakitas M., Furstenberg C., et al. (2004). Patients' need for information about cancer therapy. Oncology Nursing Forum, 31, 313320.
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, 745754.
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, 23772382.
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. 96131. Washington, DC: National Academy Press.
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.
Whedon M. (2001). Revisiting the road not taken: Integrating palliative care into oncology nursing. Clinical Journal of Oncology Nursing, 6, 2733.
World Health Organization. (2003). Palliative care: What is it. Retrieved December, 2005, from www.who.org.
Zimmermann C., Riechelmann R., Krzyzanowska M., et al. (2008). Effectiveness of specialized palliative care: A systematic review. JAMA, 299, 16981709.
Recommend this journal

Email your librarian or administrator to recommend adding this journal to your organisation's collection.

Palliative & Supportive Care
  • ISSN: 1478-9515
  • EISSN: 1478-9523
  • URL: /core/journals/palliative-and-supportive-care
Please enter your name
Please enter a valid email address
Who would you like to send this to? *
×

Keywords:

Metrics

Altmetric attention score

Full text views

Total number of HTML views: 10
Total number of PDF views: 101 *
Loading metrics...

Abstract views

Total abstract views: 611 *
Loading metrics...

* Views captured on Cambridge Core between September 2016 - 19th November 2017. This data will be updated every 24 hours.