Clinical trial · Interventional
A Primary Palliative Care Intervention for Patients With Advanced Cancer
A Cluster Randomized Trial of a Primary Palliative Care Intervention (CONNECT) for Patients With Advanced Cancer
NCT02712229CI-TRIAL-00051118CONNECTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CONNECT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CONNECT Intervention
- description
- 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.
- interventionNames
- Behavioral: CONNECT
- type
- NO_INTERVENTION
- label
- Usual Care Control
- description
- At clinics randomized to Usual Care, enrolled patients and caregivers will continue to receive supportive oncology care according to usual practice.
Primary outcomes (1)
- measure
- Quality of Life - patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Participants will be (1) patients with advanced cancer receiving care at a participating clinic; (2) their caregivers; (3) their oncology staff nurses, oncologists, and practice managers. Patient eligibility criteria. Inclusion criteria: (1) adults (≥ 21 years old); (2) the oncologist "would not be surprised if the patient died in the next year"; (3) Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤ 2; (4) planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly. Exclusion criteria: (1) Unable to read and respond to questions in English; (2) cognitive impairment or inability to consent to treatment, as determined by the patient's oncologist; (3) unable to complete baseline interview; (4) ECOG PS of 3 (capable of limited self-care; confined to bed or chair \> 50% of waking hours) or 4 (cannot carry on any self-care; totally confined to bed or chair); (5) hematologic malignancy. Caregiver eligibility criteria. Inclusion criteria: (1) adults (≥ 21 years old); (2) family member or friend of an eligible patient. Exclusion criteria: (1) unable to read and respond to questions in English; (2) unable to complete the baseline interview. Patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it. Clinician eligibility criteria. Oncology staff nurses who undergo training to deploy CONNECT, oncologists, and practice managers at participating sites will be eligible to participate.
References
Publications (24)
- BACKGROUNDSchenker 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
- BACKGROUNDDowney 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. PMID 20398115
- BACKGROUNDGiesinger 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. PMID 21711125
- BACKGROUNDZhang 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. PMID 19273778
- BACKGROUNDWright 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. PMID 18840840
- BACKGROUNDBarnato 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. PMID 17446824