Skip to main content
    • Aa
    • Aa

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)...

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.


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.


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.

Corresponding author
Address correspondence and reprint requests to: Marie Bakitas, Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756. E-mail:
Hide All
M. Bakitas , T. Ahles , K. Skalla , (2008). Proxy perspectives on end-of-life care. Cancer, 112, 18541861.

M. Bakitas , K.D. Lyons , J. Dixon , (2006). Palliative Care Program Effectiveness Research: Developing rigor in sampling design, conduct and reporting. Journal of Pain and Symptom Management, 31, 270284.

M. Bakitas , M. Stevens , T. Ahles , (2004). Project ENABLE: A palliative care demonstration project for advanced cancer patients in three settings. Journal of Palliative Medicine, 7, 363372.

I. Byock , J.S. Twohig , M. Merriman , (2006). Promoting excellence in end-of-life care: A report on innovative models of palliative care. Journal of Palliative Medicine, 9, 137151.

V.T. Chang , S.S. Hwang , & M Feuerman . (2000). Validation of the Edmonton Symptom Assessment Scale. Cancer, 88, 21642171.

V.S. Conn , P.S. Cooper , T.M. Ruppar , (2008). Searching for the intervention in intervention research reports. Journal of Nursing Scholarship, 40, 5259.

A.M. Cook , I.G. Finlay , & R.J Butler-Keating . (2002). Recruiting into palliative care trials: Lessons learnt from a feasibility study. Palliative Medicine, 16, 163165.

D.C. Currow , A.P. Abernethy , T.M. Shelby-James , (2006). The impact of conducting a regional palliative care clinical study. Palliative Medicine, 20, 735743.

R.A. Dean , & S.E McClement . (2002). Palliative care research: Methodological and ethical challenges. International Journal of Palliative Nursing, 8, 376380.

G. Ewing , M. Rogers , S. Barclay , (2004). Recruiting patients into a primary care based study of palliative care: Why is it so difficult? Palliative Medicine, 18, 452459.

G Grande . (2000). Why are trials in palliative care so difficult? Palliative Medicine, 14, 6974.

M. Hegel , J. Barrett , & T Oxman . (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.

P.S. Hinds , E.A. Burghen , & M Pritchard . (2007). Conducting end-of-life studies in pediatric oncology. Western Journal of Nursing Research, 29, 448465.

B. Holzner , G. Kemmler , D. Cella , (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.

J.B. Hopkinson , D.N. Wright , & J.L Corner . (2005). Seeking new methodology for palliative care research: Challenging assumptions about studying people who are approaching the end of life. Palliative Medicine, 19, 532537.

P. Hudson , S. Aranda , & N McMurray . (2001). Randomized controlled trials in palliative care: Overcoming the obstacles. International Journal of Palliative Nursing, 7, 427434.

M.S. Jordhoy , S. Kaasa , P.M. Fayers , (1999). Challenges in palliative care research; recruitment, attrition and compliance: Experience from a randomized controlled trial. Palliative Medicine, 13, 299310.

K.D. Lyons , M. Bakitas , M.T. Hegel , (2009). Reliability and validity of the functional assessment of chronic illness therapy-palliative care (FACIT-Pal) Scale. Journal of Pain & Symptom Management, 37, 2332.

C. Mazzocato , C. Sweeney , & E Bruera . (2001). Clinical research in palliative care: Patient populations, symptoms, interventions and endpoints. Palliative Medicine, 15, 163168.

S.C. McMillan , B.J. Small , M.A. Weitzsner , (2005). Impact of coping skills intervention with family caregivers of hospitce patients with cancer: A randomized clinical trial. Cancer, 106, 214222.

S.C. McMillan & M.A Weitzsner . (2003). Methodologic issues in collecting data from debilitated patients with cancer near the end of life. Oncology Nursing Forum, 30, 123129.

H. McQuay & A Moore . (1994). Need for rigorous assessment of palliative care. British Medical Journal, 309, 13151316.

I. McWhinney , M. Bass , & A Donner . (1994). Evaluation of a palliative care service: Problems and pitfalls. British Medical Journal, 309, 13401342.

F. Meyers & J Linder . (2003). Simultaneous care: Disease treatment and palliative care throughout illness. Journal of Clinical Oncology, 21, 14121415.

D.L Morgan . (1998). Practical strategies for combining qualitative and quantitative methods: Applications to health research. Qualitative Health Research, 8, 362376.

R.A. Mularski , K. Rosenfeld , S. Coons , (2007). Measuring outcomes in randomized prospective trials in palliative care. Journal of Pain & Symptom Management, 34, S7S19.

L.L. Northouse , T. Rosset , L. Phillips , (2006). Research with families facing cancer: The challenges of accrual and retention. Research in Nursing and Health, 29, 199211.

A. Okun , R. Stein , L. Buman , (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.

D Oxenham . (1998). Accuracy of prediction of survival by different professional groups in a hospice. Palliative Medicine, 12, 117118.

R.M Pickering . (2002). Statistical aspects of measurement in palliative care. Palliative Medicine, 16, 359364.

E. Pitorak , M. Armour , & H Sivec . (2003). Project Safe Conduct integrates palliative goals into comprehensive cancer center. Journal of Palliative Medicine, 6, 645655.

L Radloff . (1977). The CES-D Scale: A self report depression scale for research in the general population. Applied Psychological Measurement, 1, 385401.

A.J. Roth , A.B. Kornblith , L. Batel-Copel , (1998). Rapid screening for psychologic distress in men with prostate carcinoma. Cancer, 82, 19041908.

M Sandelowski . (1996). Using qualitative methods in intervention studies. Research in Nursing and Health, 19, 359364.

C. Sepulveda , A. Yoshida , & T Ullrich . (2002). Palliative care: The World Health Organization's global perspective. Journal of Pain & Symptom Management, 24, 9196.

J. Singer & J Willett . (2003). Applied Longitudinal Data Analysis: Modeling Change and Event Occurrence. New York: Oxford University Press.

K. Skalla , M. Bakitas , C. Furstenberg , (2004). Patients' need for information about cancer therapy. Oncology Nursing Forum, 31, 313320.

K.E. Steinhauser , E.C. Clipp , J.C. Hays , (2006). Identifying, recruiting, and retaining seriously ill patients and their caregivers in longitudinal research. Palliative Medicine, 20, 745754.

J. Temel , V. Jackson , A. Billings , (2007). Phase II Study: Integrated palliative care in newly diagnosed advanced non-small cell lung cancer patients. Journal of Clinical Oncology, 25, 23772382.

M Whedon . (2001). Revisiting the road not taken: Integrating palliative care into oncology nursing. Clinical Journal of Oncology Nursing, 6, 2733.

C. Zimmermann , R. Riechelmann , M. Krzyzanowska , (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? *



Altmetric attention score

Full text views

Total number of HTML views: 10
Total number of PDF views: 90 *
Loading metrics...

Abstract views

Total abstract views: 546 *
Loading metrics...

* Views captured on Cambridge Core between September 2016 - 17th October 2017. This data will be updated every 24 hours.