A Primary Palliative Care Intervention for Patients With Advanced Cancer

NCT02712229 | Completed

• 2 other identifiers: PRO151201545R01CA197103-02
• Study Type: interventional
• Target: 1,290
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to test whether a nurse-led intervention to improve provision of primary palliative care within oncology practices (CONNECT) can decrease morbidity for patients with advanced cancer and their caregivers. 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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Quality of Life - patient

  The investigators will compare change in the 3-month FACIT-Pal scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.

  Change from baseline to 3 months

Secondary Outcomes (6)

• Symptom burden - patient

  Change from baseline to 3 months

• Depression and anxiety symptoms - patient

  Change from baseline to 3 months

• Depression and anxiety symptoms - caregiver

  Change from baseline to 3 months

• Caregiver burden - caregiver

  Change from baseline to 3 months

• Healthcare Utilization

  1 year

Other Outcomes (8)

• Patient-Oncologist Therapeutic Relationship

  Change from baseline to 3 months

• Hope - patients and caregivers

  Change from baseline to 3 months

• Self-efficacy - patients and caregivers

  3 months

Study Arms (2)

CONNECT Intervention

EXPERIMENTAL

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.

Behavioral: CONNECT

Usual Care Control

NO INTERVENTION

At clinics randomized to Usual Care, enrolled patients and caregivers will continue to receive supportive oncology care according to usual practice.

Interventions

CONNECT BEHAVIORAL

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.

CONNECT Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Clinician eligibility criteria. Oncology staff nurses who undergo training to deploy CONNECT, oncologists, and practice managers at participating sites will be eligible to participate.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (24)

• 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.

  PMID: 25517219 BACKGROUND

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• 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.

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• 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.

  PMID: 23107181 BACKGROUND

• 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.

  PMID: 10986063 BACKGROUND

• 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.

  PMID: 11255393 BACKGROUND

• 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.

  PMID: 18089870 BACKGROUND

• 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.

  PMID: 19894078 BACKGROUND

• 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.

  PMID: 20818875 BACKGROUND

• 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.

  PMID: 19690306 BACKGROUND

• 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.

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• 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.

  PMID: 20233823 BACKGROUND

• 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.

  PMID: 23942596 BACKGROUND

• 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.

  PMID: 24673544 BACKGROUND

• 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.

  PMID: 24301842 BACKGROUND

• 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.

  PMID: 40782786 DERIVED

• 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.

  PMID: 38574330 DERIVED

• 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.

  PMID: 36472545 DERIVED

• 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.

  PMID: 34767474 DERIVED

• 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.

  PMID: 34515737 DERIVED

• 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.

  PMID: 33547717 DERIVED

Study Officials

• Yael Schenker, MD, MAS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MAS

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 18, 2016
• Study Start: July 27, 2016
• Primary Completion: January 27, 2020
• Study Completion: October 15, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)