Advanced CancerCONNECTNCT02712229
A Primary Palliative Care Intervention for Patients With Advanced Cancer
A study testing CONNECT in people with Advanced Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- CONNECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,290 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2016to 15 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Trial of a Primary Palliative Care Intervention (CONNECT) for Patients With Advanced Cancer
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.
Read the detailed description
Study investigators will conduct a cluster randomized controlled trial comparing the CONNECT intervention to usual care in 16 oncology clinics. CONNECT (Care Management by Oncology Nurses to address supportive care needs) is a care management intervention using existing oncology nurses to improve provision of primary palliative care within outpatient oncology practices.
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
- Advanced Cancer
- Being tested
- CONNECT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNECTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 3 months
Secondary outcomes (6)
Symptom burden - patient
The investigators will compare change in the 3-month Edmonton Symptom Assessment Scale (ESAS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Measured: Change from baseline to 3 months
Depression and anxiety symptoms - patient
The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Measured: Change from baseline to 3 months
Depression and anxiety symptoms - caregiver
The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.
Measured: Change from baseline to 3 months
Caregiver burden - caregiver
The investigators will compare change in the 3-month Zarit Burden Interview-Short scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.
Measured: Change from baseline to 3 months
Healthcare Utilization
To inform future dissemination efforts and aid in understanding optimal financing models, the investigators will calculate implementation costs of the intervention and determine the effects of CONNECT on healthcare utilization, including hospitalizations, chemotherapy use, and hospice use.
Measured: 1 year
Survival - patients
The investigators will calculate survival time from date of enrollment using the Kaplan-Meier method. We will use frailty models to assess for any effect of CONNECT on survival, controlling for the effects of clustering.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start27 Jul 2016
- Primary completion27 Jan 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Yael Schenker, MD, MAS, University of Pittsburgh
- Investigators
- Yael Schenker, MD, MAS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712229
- Sponsor's protocol ID
- PRO15120154
- Other IDs
- 5R01CA197103-02
- Acronym
- CONNECT
- Status last verified
- Apr 2021
- First submitted
- 7 Mar 2016
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25517219Downey 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.
PubMed 20398115Giesinger 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.
PubMed 21711125Zhang 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.
PubMed 19273778Wright 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.
PubMed 18840840Barnato 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.
PubMed 17446824Northouse 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.
PubMed 23107181Detmar 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.
PubMed 10986063Detmar 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.
PubMed 11255393Pollak 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.
PubMed 18089870Temel 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.
PubMed 19894078Temel 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.
PubMed 20818875Bakitas 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.
PubMed 19690306Zimmermann 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.
PubMed 24559581Hui 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.
PubMed 20233823
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Trial of a Primary Palliative Care Intervention (CONNECT) for Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT02712229
- Acronym / sponsor ID
- CONNECT / PRO15120154
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Jul 2016 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study investigators will conduct a cluster randomized controlled trial comparing the CONNECT intervention to usual care in 16 oncology clinics. CONNECT (Care Management by Oncology Nurses to address supportive care needs) is a care management intervention using existing oncology nurses to improve provision of primary palliative care within outpatient oncology practices.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONNECT Intervention | Experimental | Behavioral: CONNECTAt 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONNECTPrimary 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. | Behavioural | CONNECT Intervention |
Primary outcome
Quality of Life - patient
Time frame: Change from baseline to 3 months
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.
6 secondary outcomes
Symptom burden - patient
Time frame: Change from baseline to 3 months
Depression and anxiety symptoms - patient
Time frame: Change from baseline to 3 months
Depression and anxiety symptoms - caregiver
Time frame: Change from baseline to 3 months
Caregiver burden - caregiver
Time frame: Change from baseline to 3 months
Healthcare Utilization
Time frame: 1 year
Survival - patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 25517219Schenker 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.
- Background: PubMed 20398115Downey 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.
- Background: PubMed 21711125Giesinger 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.
- Background: PubMed 19273778Zhang 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.
- Background: PubMed 18840840Wright 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.
- Background: PubMed 17446824Barnato 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.
- Background: PubMed 23107181Northouse 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.
- Background: PubMed 10986063Detmar 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.
- Background: PubMed 11255393Detmar 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.
- Background: PubMed 18089870Pollak 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.
- Background: PubMed 19894078Temel 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.
- Background: PubMed 20818875Temel 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.
- Individual participant dataSharing planned: No
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Schenker, MD, MAS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONNECT in people with Advanced Cancer, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life - patient (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712229, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.