A Primary Palliative Care Intervention for Patients With Advanced Cancer
NCT ID: NCT02712229
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1290 participants
INTERVENTIONAL
2016-07-27
2020-10-15
Brief Summary
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The specific aims are to:
Aim 1. Assess the effects of CONNECT on patient quality of life (primary outcome), symptom burden, and mood at 3-month follow-up.
Aim 2. Assess the effects of CONNECT on caregiver burden and mood at 3-month follow-up.
Aim 3. Assess the effects of CONNECT on healthcare resource use over 1 year of follow-up.
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Detailed Description
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The study will enroll 672 patients with advanced cancer and their caregivers. The study will assess the intervention's impact on patient and caregiver quality-of-life and psychological outcomes at three months and on healthcare utilization through one year of follow up. Investigators will follow a rigorous plan to establish and maintain intervention fidelity. Detailed process information will be collected at all sites and the study will evaluate how CONNECT impacts mortality and costs.
Following best practices for complex system-level interventions, the study will use a cluster randomized trial design. The unit of randomization is the oncology practice, defined as a unique location and provider group for outpatient oncology care. The unit of analysis is the individual patient and caregiver.
Designated staff at each clinic will review oncologists' schedules on a weekly basis to identify and track potentially eligible patients with an upcoming appointment. Research staff will review tracking systems weekly to maintain recruitment fidelity. Identified patients will receive a 1-page study information sheet at their next clinic visit, followed by a detailed in-person explanation of the study from a trained staff member. This staff member will obtain informed consent from all participants. To minimize potential selection bias, participants will be told in advance of both groups and not randomized if they decline to be exposed to one of them.
To enhance retention, blinded research assistants will conduct monthly follow-up calls to assess healthcare utilization for participants in both groups. The data collection strategy is designed to minimize participant burden by using parsimonious measures previously pilot-tested with this population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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CONNECT Intervention
At clinics randomized to the CONNECT intervention, oncology nurses will be selected by a nurse advisory panel to receive standardized primary palliative care training. A multi-step deployment strategy will be employed to orient oncologists and implement CONNECT processes. CONNECT nurses will administer CONNECT to enrolled patients and caregivers. An intervention fidelity monitoring and maintenance plan will be implemented to ensure high quality and consistent delivery of the intervention.
CONNECT
Primary palliative care, care management intervention led by existing oncology nurses. Deployed through a series of nurse-led encounters before or after regularly scheduled oncology visits. Based on best practices in palliative oncology care, the first visit focuses on establishing rapport, addressing symptom needs and choosing a surrogate decision maker. Subsequent visits include additional focus on treatment preferences and future goals.
Visits are guided by patient-reported outcomes. During all encounters, the nurse works with patients/caregivers to complete/update individualized Shared Care Plans. After all visits, the nurse discusses patients' symptoms, preferences and goals with their oncologists via a mandatory check-in session and a follow-up call with the patient and/or caregiver.
Usual Care Control
At clinics randomized to Usual Care, enrolled patients and caregivers will continue to receive supportive oncology care according to usual practice.
No interventions assigned to this group
Interventions
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CONNECT
Primary palliative care, care management intervention led by existing oncology nurses. Deployed through a series of nurse-led encounters before or after regularly scheduled oncology visits. Based on best practices in palliative oncology care, the first visit focuses on establishing rapport, addressing symptom needs and choosing a surrogate decision maker. Subsequent visits include additional focus on treatment preferences and future goals.
Visits are guided by patient-reported outcomes. During all encounters, the nurse works with patients/caregivers to complete/update individualized Shared Care Plans. After all visits, the nurse discusses patients' symptoms, preferences and goals with their oncologists via a mandatory check-in session and a follow-up call with the patient and/or caregiver.
Eligibility Criteria
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Inclusion Criteria
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Yael Schenker, MD, MAS
MD, MAS
Principal Investigators
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Yael Schenker, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
Countries
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References
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Schenker Y, White D, Rosenzweig M, Chu E, Moore C, Ellis P, Nikolajski P, Ford C, Tiver G, McCarthy L, Arnold R. Care management by oncology nurses to address palliative care needs: a pilot trial to assess feasibility, acceptability, and perceived effectiveness of the CONNECT intervention. J Palliat Med. 2015 Mar;18(3):232-40. doi: 10.1089/jpm.2014.0325. Epub 2014 Dec 17.
Downey L, Engelberg RA. Quality-of-life trajectories at the end of life: assessments over time by patients with and without cancer. J Am Geriatr Soc. 2010 Mar;58(3):472-9. doi: 10.1111/j.1532-5415.2010.02734.x.
Giesinger JM, Wintner LM, Oberguggenberger AS, Gamper EM, Fiegl M, Denz H, Kemmler G, Zabernigg A, Holzner B. Quality of life trajectory in patients with advanced cancer during the last year of life. J Palliat Med. 2011 Aug;14(8):904-12. doi: 10.1089/jpm.2011.0086. Epub 2011 Jun 28.
Zhang B, Wright AA, Huskamp HA, Nilsson ME, Maciejewski ML, Earle CC, Block SD, Maciejewski PK, Prigerson HG. Health care costs in the last week of life: associations with end-of-life conversations. Arch Intern Med. 2009 Mar 9;169(5):480-8. doi: 10.1001/archinternmed.2008.587.
Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.
Barnato AE, Herndon MB, Anthony DL, Gallagher PM, Skinner JS, Bynum JP, Fisher ES. Are regional variations in end-of-life care intensity explained by patient preferences?: A Study of the US Medicare Population. Med Care. 2007 May;45(5):386-93. doi: 10.1097/01.mlr.0000255248.79308.41.
Northouse LL, Katapodi MC, Schafenacker AM, Weiss D. The impact of caregiving on the psychological well-being of family caregivers and cancer patients. Semin Oncol Nurs. 2012 Nov;28(4):236-45. doi: 10.1016/j.soncn.2012.09.006.
Detmar SB, Aaronson NK, Wever LD, Muller M, Schornagel JH. How are you feeling? Who wants to know? Patients' and oncologists' preferences for discussing health-related quality-of-life issues. J Clin Oncol. 2000 Sep 15;18(18):3295-301. doi: 10.1200/JCO.2000.18.18.3295.
Detmar SB, Muller MJ, Wever LD, Schornagel JH, Aaronson NK. The patient-physician relationship. Patient-physician communication during outpatient palliative treatment visits: an observational study. JAMA. 2001 Mar 14;285(10):1351-7. doi: 10.1001/jama.285.10.1351.
Pollak KI, Arnold RM, Jeffreys AS, Alexander SC, Olsen MK, Abernethy AP, Sugg Skinner C, Rodriguez KL, Tulsky JA. Oncologist communication about emotion during visits with patients with advanced cancer. J Clin Oncol. 2007 Dec 20;25(36):5748-52. doi: 10.1200/JCO.2007.12.4180.
Temel JS, Greer JA, Admane S, Solis J, Cashavelly BJ, Doherty S, Heist R, Pirl WF. Code status documentation in the outpatient electronic medical records of patients with metastatic cancer. J Gen Intern Med. 2010 Feb;25(2):150-3. doi: 10.1007/s11606-009-1161-z. Epub 2009 Nov 6.
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.
Hui D, Elsayem A, De la Cruz M, Berger A, Zhukovsky DS, Palla S, Evans A, Fadul N, Palmer JL, Bruera E. Availability and integration of palliative care at US cancer centers. JAMA. 2010 Mar 17;303(11):1054-61. doi: 10.1001/jama.2010.258.
Maciasz RM, Arnold RM, Chu E, Park SY, White DB, Vater LB, Schenker Y. Does it matter what you call it? A randomized trial of language used to describe palliative care services. Support Care Cancer. 2013 Dec;21(12):3411-9. doi: 10.1007/s00520-013-1919-z. Epub 2013 Aug 14.
Schenker Y, Park SY, Maciasz R, Arnold RM. Do patients with advanced cancer and unmet palliative care needs have an interest in receiving palliative care services? J Palliat Med. 2014 Jun;17(6):667-72. doi: 10.1089/jpm.2013.0537. Epub 2014 Mar 27.
Schenker Y, Crowley-Matoka M, Dohan D, Rabow MW, Smith CB, White DB, Chu E, Tiver GA, Einhorn S, Arnold RM. Oncologist factors that influence referrals to subspecialty palliative care clinics. J Oncol Pract. 2014 Mar;10(2):e37-44. doi: 10.1200/JOP.2013.001130. Epub 2013 Dec 3.
Booth G, Rahman M, Rosenzweig M, Thomas TH, Schenker Y. What's on your mind? A qualitative analysis of concerns and self-management strategies among older adults with advanced cancer. J Geriatr Oncol. 2025 Sep;16(7):102328. doi: 10.1016/j.jgo.2025.102328. Epub 2025 Aug 8.
Bell SG, Althouse AD, Belin SC, Arnold RM, Smith KJ, White DB, Chu E, Schenker Y, Thomas TH. Associations of Health Care Utilization and Therapeutic Alliance in Patients with Advanced Cancer. J Palliat Med. 2024 Apr;27(4):515-520. doi: 10.1089/jpm.2023.0559.
Mitchell CJ, Althouse A, Feldman R, Arnold RM, Rosenzweig M, Smith K, Chu E, White D, Smith T, Schenker Y. Symptom Burden and Shared Care Planning in an Oncology Nurse-Led Primary Palliative Care Intervention (CONNECT) for Patients with Advanced Cancer. J Palliat Med. 2023 May;26(5):667-673. doi: 10.1089/jpm.2022.0277. Epub 2022 Dec 5.
Sigler LE, Althouse AD, Thomas TH, Arnold RM, White D, Smith TJ, Chu E, Rosenzweig M, Smith KJ, Schenker Y. Effects of an Oncology Nurse-Led, Primary Palliative Care Intervention (CONNECT) on Illness Expectations Among Patients With Advanced Cancer. JCO Oncol Pract. 2022 Apr;18(4):e504-e515. doi: 10.1200/OP.21.00573. Epub 2021 Nov 12.
Schenker Y, Althouse AD, Rosenzweig M, White DB, Chu E, Smith KJ, Resick JM, Belin S, Park SY, Smith TJ, Bakitas MA, Arnold RM. Effect of an Oncology Nurse-Led Primary Palliative Care Intervention on Patients With Advanced Cancer: The CONNECT Cluster Randomized Clinical Trial. JAMA Intern Med. 2021 Nov 1;181(11):1451-1460. doi: 10.1001/jamainternmed.2021.5185.
Thomas T, Althouse A, Sigler L, Arnold R, Chu E, White DB, Rosenzweig M, Smith K, Smith TJ, Schenker Y. Stronger therapeutic alliance is associated with better quality of life among patients with advanced cancer. Psychooncology. 2021 Jul;30(7):1086-1094. doi: 10.1002/pon.5648. Epub 2021 Mar 8.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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PRO15120154
Identifier Type: -
Identifier Source: org_study_id
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