Non-small Cell Lung CancerNCT01038271
Integrated Versus Standard Palliative Care in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
A study testing Standard Palliative Care Group and Integrated Palliative Care Intervention in people with Non-small Cell Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Standard Palliative Care Group and Integrated Palliative Care Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed incurable NSCLC, stage IIIB with a pleural or pericardial effusion or stage IV
- Performance status 0-2
- Diagnosis of advanced NSCLC within the previous eight weeks
- Ability to read and respond to questions in English
- Permission of attending physician
Who cannot join
- Prior chemotherapy for metastatic disease
- Existence of other co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
The main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung cancer. Palliative care is care that tries to lessen the symptoms of a disease. Although many people with advanced lung cancer receive palliative care or hospice toward the end of their disease, the entire course of their disease is often complicated by physical and emotional difficulties. Palliative care may be useful when it is started soon after diagnosis.
Read the detailed description
- Participants with advanced small-cell lung cancer, will be asked to fill out some quality of life questionnaires that help to measure their quality of life (QOL), mood and understanding of their illness. They will also be asked to identify an important person in their life, either a relative or friend, who they count on for help and support. The research staff will contact that individual and ask them to if they want to participate in the caregiver part of this study.
- Lung cancer participants will then be randomized into one of the two study groups: integrated palliative care or standard palliative care.
- Participants assigned to the Standard palliative care group will be referred to the Palliative Care Team at their doctor's or their request at any time. At that time the Palliative Care Team (PCT) will follow and treat the participant as they would any other cancer patient. Research staff will request the participant to fill out QOL, mood \& illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
- Participants assigned to the Integrated Palliative Care group will have an appointment with the Palliative Care Team within 3 weeks of being randomized. The palliative care physician will formulate a care plan based on the participant's and caregiver's issues and needs. The PCT will meet with the participant on a regular basis, a minimum of every 6 weeks. These visits wil vary with the participant's needs and may include individual or group meetings with the physicians, nurse practitioners, social workers or chaplains. Research staff will ask you to fill out QOL, mood \& illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
- Participants will be in this research study for about 24 weeks or 6 months. After this 6 month period is over, care by the Palliative Care Team my continue but the participants will not be asked to fill out more questionnaires.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Standard Palliative Care Group, Integrated Palliative Care Intervention
- Keywords
- palliative care
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Palliative Care GroupOther
Participant is referred to the Palliative Care Team at any time.
Integrated Palliative Care InterventionOther
Participant meets with the Palliative Care Team within 3 weeks of being randomized
| Study group | Role | What they receive |
|---|---|---|
| Standard Palliative Care Group | Active comparator | Not described Receives: Other: Standard Palliative Care Group |
| Integrated Palliative Care Group | Active comparator | Not described Receives: Other: Integrated Palliative Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
Measured: 3 years
Secondary outcomes (7)
Assess the impact of early integration with palliative care on mood and illness understanding.
Measured: 3 years
Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death.
Measured: 3 years
Compare hospice referrals and length of stay on hospice between study arms.
Measured: 3 years
Compare outpatient code status documentation between study arms.
Measured: 3 years
Compare the percentage of patients on each arm who received chemotherapy within one month of death.
Measured: 3 years
Determine the amount of time palliative care devotes to illness understanding, symptom management, decision-making, and coping with an illness in the outpatient setting.
Measured: 3 years
Health Care Costs
We will utilize the hospital cost accounting/billing system to determine health care costs as per study arm
Measured: After death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startMay 2006
- Primary completionJul 2009
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Responsible party
- Principal investigator, Jennifer Temel, MD, Massachusetts General Hospital
- Investigators
- Jennifer Temel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038271
- Sponsor's protocol ID
- 06-030
- Status last verified
- Mar 2018
- First submitted
- 21 Dec 2009
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20818875Jacobsen J, Jackson V, Dahlin C, Greer J, Perez-Cruz P, Billings JA, Pirl W, Temel J. Components of early outpatient palliative care consultation in patients with metastatic nonsmall cell lung cancer. J Palliat Med. 2011 Apr;14(4):459-64. doi: 10.1089/jpm.2010.0382. Epub 2011 Mar 18.
PubMed 21417739Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.
PubMed 21555700Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
PubMed 22203758Pirl WF, Greer JA, Traeger L, Jackson V, Lennes IT, Gallagher ER, Perez-Cruz P, Heist RS, Temel JS. Depression and survival in metastatic non-small-cell lung cancer: effects of early palliative care. J Clin Oncol. 2012 Apr 20;30(12):1310-5. doi: 10.1200/JCO.2011.38.3166. Epub 2012 Mar 19.
PubMed 22430269Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.
PubMed 23358690
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Integrated vs. Standard Palliative Care in Patients With Advanced NSCLC
- ClinicalTrials.gov ID
- NCT01038271
- Acronym / sponsor ID
- 06-030
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Society of Clinical Oncology
- Study start
- May 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Dec 2009 (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 main purpose of this study is to compare two types of treatment-standard palliative care (which usually is given towards the end of life) and integrated palliative care (which is given soon after diagnosis) to see which is better for improving quality of life of participants with advanced non-small cell lung cancer. Palliative care is care that tries to lessen the symptoms of a disease. Although many people with advanced lung cancer receive palliative care or hospice toward the end of their disease, the entire course of their disease is often complicated by physical and emotional difficulties. Palliative care may be useful when it is started soon after diagnosis.
Detailed description
- Participants with advanced small-cell lung cancer, will be asked to fill out some quality of life questionnaires that help to measure their quality of life (QOL), mood and understanding of their illness. They will also be asked to identify an important person in their life, either a relative or friend, who they count on for help and support. The research staff will contact that individual and ask them to if they want to participate in the caregiver part of this study.
- Lung cancer participants will then be randomized into one of the two study groups: integrated palliative care or standard palliative care.
- Participants assigned to the Standard palliative care group will be referred to the Palliative Care Team at their doctor's or their request at any time. At that time the Palliative Care Team (PCT) will follow and treat the participant as they would any other cancer patient. Research staff will request the participant to fill out QOL, mood \& illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
- Participants assigned to the Integrated Palliative Care group will have an appointment with the Palliative Care Team within 3 weeks of being randomized. The palliative care physician will formulate a care plan based on the participant's and caregiver's issues and needs. The PCT will meet with the participant on a regular basis, a minimum of every 6 weeks. These visits wil vary with the participant's needs and may include individual or group meetings with the physicians, nurse practitioners, social workers or chaplains. Research staff will ask you to fill out QOL, mood \& illness understanding questionnaires about 12, 18 and 24 weeks after they sign the consent form. Their caregiver will be asked to fill out the FamCare form at 12, 18 and 24 weeks.
- Participants will be in this research study for about 24 weeks or 6 months. After this 6 month period is over, care by the Palliative Care Team my continue but the participants will not be asked to fill out more questionnaires.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Palliative Care Group | Active comparator | Other: Standard Palliative Care Group |
| Integrated Palliative Care Group | Active comparator | Other: Integrated Palliative Care Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed incurable NSCLC, stage IIIB with a pleural or pericardial effusion or stage IV
- Performance status 0-2
- Diagnosis of advanced NSCLC within the previous eight weeks
- Ability to read and respond to questions in English
- Permission of attending physician
Key exclusion criteria (2 listed)
- Prior chemotherapy for metastatic disease
- Existence of other co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol
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 |
|---|---|---|
| Standard Palliative Care GroupParticipant is referred to the Palliative Care Team at any time. | Other | Standard Palliative Care Group |
| Integrated Palliative Care InterventionParticipant meets with the Palliative Care Team within 3 weeks of being randomized | Other | Integrated Palliative Care Group |
Primary outcome
Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC.
Time frame: 3 years
7 secondary outcomes
Assess the impact of early integration with palliative care on mood and illness understanding.
Time frame: 3 years
Assess the impact of early integration with palliative care on family caregiver satisfaction, mood, and QOL both during care and after death.
Time frame: 3 years
Compare hospice referrals and length of stay on hospice between study arms.
Time frame: 3 years
Compare outpatient code status documentation between study arms.
Time frame: 3 years
Compare the percentage of patients on each arm who received chemotherapy within one month of death.
Time frame: 3 years
Determine the amount of time palliative care devotes to illness understanding, symptom management, decision-making, and coping with an illness in the outpatient setting.
Time frame: 3 years
Health Care Costs
Time frame: After death
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 21 Mar 2018.
- Results publication: 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.
- Results publication: PubMed 21417739Jacobsen J, Jackson V, Dahlin C, Greer J, Perez-Cruz P, Billings JA, Pirl W, Temel J. Components of early outpatient palliative care consultation in patients with metastatic nonsmall cell lung cancer. J Palliat Med. 2011 Apr;14(4):459-64. doi: 10.1089/jpm.2010.0382. Epub 2011 Mar 18.
- Results publication: PubMed 21555700Temel JS, Greer JA, Admane S, Gallagher ER, Jackson VA, Lynch TJ, Lennes IT, Dahlin CM, Pirl WF. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care. J Clin Oncol. 2011 Jun 10;29(17):2319-26. doi: 10.1200/JCO.2010.32.4459. Epub 2011 May 9.
- Results publication: PubMed 22203758Greer JA, Pirl WF, Jackson VA, Muzikansky A, Lennes IT, Heist RS, Gallagher ER, Temel JS. Effect of early palliative care on chemotherapy use and end-of-life care in patients with metastatic non-small-cell lung cancer. J Clin Oncol. 2012 Feb 1;30(4):394-400. doi: 10.1200/JCO.2011.35.7996. Epub 2011 Dec 27.
- Results publication: PubMed 22430269Pirl WF, Greer JA, Traeger L, Jackson V, Lennes IT, Gallagher ER, Perez-Cruz P, Heist RS, Temel JS. Depression and survival in metastatic non-small-cell lung cancer: effects of early palliative care. J Clin Oncol. 2012 Apr 20;30(12):1310-5. doi: 10.1200/JCO.2011.38.3166. Epub 2012 Mar 19.
- Results publication: PubMed 23358690Yoong J, Park ER, Greer JA, Jackson VA, Gallagher ER, Pirl WF, Back AL, Temel JS. Early palliative care in advanced lung cancer: a qualitative study. JAMA Intern Med. 2013 Feb 25;173(4):283-90. doi: 10.1001/jamainternmed.2013.1874.
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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.
Jennifer Temel, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Palliative Care Group and Integrated Palliative Care Intervention in people with Non-small Cell Lung Cancer, run by Massachusetts General Hospital 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?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 21 Mar 2018. 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?
Assess the impact of early integration with palliative care on QOL in patients with advanced NSCLC. (time frame: 3 years). 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 NCT01038271, which also lists 6 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 21 Mar 2018.