Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Mar:54:98-104.
doi: 10.1016/j.cct.2017.01.005. Epub 2017 Jan 16.

A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer: Protocol and key design considerations

Claire L Becker  1 , Robert M Arnold  2 , Seo Young Park  2 , Margaret Rosenzweig  3 , Thomas J Smith  4 , Douglas B White  5 , Kenneth J Smith  2 , Yael Schenker  6
Affiliations
Randomized Controlled Trial

A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer: Protocol and key design considerations

Claire L Becker et al. Contemp Clin Trials. 2017 Mar.

Abstract

Background: The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care-meaning basic palliative care services provided by clinicians who are not palliative care specialists-is an alternative approach that has not been rigorously evaluated.

Methods: A cluster randomized, controlled trial of the CONNECT (Care management by Oncology Nurses to address supportive care needs) intervention, an oncology nurse-led care management approach to providing primary palliative care for patients with advanced cancer and their family caregivers, is currently underway at 16 oncology practices in Western Pennsylvania. Existing oncology nurses are trained to provide symptom management and emotional support, engage patients and families in advance care planning, and coordinate appropriate care using evidence-based care management strategies. The trial will assess the impact of CONNECT versus standard oncology care on patient quality of life (primary outcome), symptom burden, and mood; caregiver burden and mood; and healthcare resource use.

Discussion: This trial addresses the need for more accessible models of palliative care by evaluating an intervention led by oncology nurses that can be widely disseminated in community oncology settings. The design confronts potential biases in palliative care research by randomizing at the practice level to avoid contamination, enrolling patients prior to informing them of group allocation, and conducting blinded outcome assessments. By collecting patient, caregiver, and healthcare utilization outcomes, the trial will enable understanding of the full range of a primary palliative care intervention's impact.

Keywords: Behavioral intervention; Caregiver; Cluster randomization; Oncology nursing; Primary palliative care; Quality of life.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Key components of CONNECT intervention visits and communication pearls.
Figure 2
Figure 2
The shared care plan is completed at every visit.
See this image and copyright information in PMC

References

    1. Downey L, Engelberg RA. Quality-of-Life Trajectories at the End of Life: Assessments over Time by Patients with and without Cancer. Journal of the American Geriatrics Society. 2010;58(3):472–479. - PMC - PubMed
    1. Teunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. Journal of pain and symptom management. 2007;34(1):94–104. - PubMed
    1. Breitbart W, Bruera E, Chochinov H, Lynch M. Neuropsychiatric syndromes and psychological symptoms in patients with advanced cancer. Journal of Pain and Symptom Management. 1995;10(2):131–141. - PubMed
    1. Hotopf M, Chidgey J, Addington-Hall J, Ly KL. Depression in advanced disease: a systematic review Part 1. Prevalence and case finding. Palliative medicine. 2002;16(2):81–97. - PubMed
    1. Northouse LL, Katapodi MC, Schafenacker AM, Weiss D. The impact of caregiving on the psychological well-being of family caregivers and cancer patients. Seminars in oncology nursing. 2012;28(4):236–245. - PubMed

Publication types