Non-small Cell Lung CancerNCT01401907
Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
A study testing early palliative care in people with Non-small Cell Lung Cancer and Small Cell Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Small Cell Lung Cancer, Mesothelioma
- What is being tested?
- early palliative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed metastatic lung cancer (NSCLC, small cell lung cancer, and mesothelioma)or non-colorectal GI cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent
- Informed of metastatic disease within the previous 8 weeks
- No prior therapy for metastatic disease
- Able to read questions in English or willing to complete questionnaires with the assistance of an interpreter
- Relative or friend of patient who will likely accompany the patient to clinic visits
Who cannot join
- Significant psychiatric or other co-morbid disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Advanced Lung and Non-colorectal Gastrointestinal Malignancies
The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.
Read the detailed description
Subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group.
Subjects who are randomized to Standard Oncology Care will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist. They will complete questionnaires at 12 weeks and 24 weeks after enrollment.
Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaires at 12 and 24 weeks after enrollment.
- Conditions
- Non-small Cell Lung Cancer, Small Cell Lung Cancer, Mesothelioma, Esophageal Cancer, Gastric Cancer, Liver Cancer
- Being tested
- early palliative care
- Keywords
- Palliative care, Lung, Gastric, Liver, Pancreatic, Esophageal, Caregiver
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Mesothelioma, Esophageal Neoplasms, Stomach Neoplasms, Liver Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early palliative careOther
patient assigned to the intervention will receive early palliative care along with standard oncology care.
| Study group | Role | What they receive |
|---|---|---|
| Early Palliative Care | Experimental | Subjects receive standard of care with early palliative care. Receives: Other: early palliative care |
| Standard of Care | No intervention | Subjects receives standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy (Quality of Life Measure)
The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
Measured: 12 weeks
Secondary outcomes (7)
Functional Assessment of Cancer Therapy (Quality of Life Measure)
The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.
Measured: 24 weeks
Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.
Measured: Week-12 and Week-24
Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.
Measured: Week12 and Week 24
Family Caregiver Quality of Life as Measured by the SF-36
The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.
Measured: Week-12 and Week-24
Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms
Measured: Week 12 and Week 24
Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer
We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.
Measured: 12 and 24 weeks
Coping (Brief Cope)
compare mean change in approach oriented coping from baseline to week-24. Approach oriented coping scale is composed of active coping, positive reframing, and acceptance subscales. Scores range from 0-8 with higher scores indicate higher approach-oriented coping
Measured: Up to week-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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
- Model description
- early palliative care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT01401907
- Sponsor's protocol ID
- 10-434
- Status last verified
- Oct 2023
- First submitted
- 20 Jul 2011
- Last updated
- 19 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: will share deidentified data with proper IRB approval
Publications
Hoerger M, Greer JA, Jackson VA, Park ER, Pirl WF, El-Jawahri A, Gallagher ER, Hagan T, Jacobsen J, Perry LM, Temel JS. Defining the Elements of Early Palliative Care That Are Associated With Patient-Reported Outcomes and the Delivery of End-of-Life Care. J Clin Oncol. 2018 Apr 10;36(11):1096-1102. doi: 10.1200/JCO.2017.75.6676. Epub 2018 Feb 23.
PubMed 29474102Greer JA, Jacobs JM, El-Jawahri A, Nipp RD, Gallagher ER, Pirl WF, Park ER, Muzikansky A, Jacobsen JC, Jackson VA, Temel JS. Role of Patient Coping Strategies in Understanding the Effects of Early Palliative Care on Quality of Life and Mood. J Clin Oncol. 2018 Jan 1;36(1):53-60. doi: 10.1200/JCO.2017.73.7221. Epub 2017 Nov 15.
PubMed 29140772
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone in Patients With Advanced Lung and Non-colorectal Gastrointestinal Malignancies
- ClinicalTrials.gov ID
- NCT01401907
- Acronym / sponsor ID
- 10-434
- Conditions
- Non-small Cell Lung Cancer, Small Cell Lung Cancer, Mesothelioma, Esophageal Cancer, Gastric Cancer, Liver Cancer
- Keywords
- Palliative care, Lung, Gastric, Liver, Pancreatic, Esophageal, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 13 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two types of care - standard oncology care and standard oncology care with early palliative care (started soon after diagnosis) to see which is better for improving the experience of patients and families with advanced lung and non-colorectal GI cancer. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.
Detailed description
Subjects and their caregiver will complete a baseline questionnaire and then be randomized to a study group.
Subjects who are randomized to Standard Oncology Care will follow up with their treating oncologist. They will consult with the palliative care team at their request or at the request of the treating oncologist. They will complete questionnaires at 12 weeks and 24 weeks after enrollment.
Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with a palliative care clinician at their next medical oncology visit or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaires at 12 and 24 weeks after enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- early palliative care
| Arm | Type | Receives |
|---|---|---|
| Early Palliative Care | Experimental | Other: early palliative careSubjects receive standard of care with early palliative care. |
| Standard of Care | No intervention | –Subjects receives standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed metastatic lung cancer (NSCLC, small cell lung cancer, and mesothelioma)or non-colorectal GI cancer (esophageal, gastric and hepatobiliary) not being treated with curative intent
- Informed of metastatic disease within the previous 8 weeks
- No prior therapy for metastatic disease
- Able to read questions in English or willing to complete questionnaires with the assistance of an interpreter
- Relative or friend of patient who will likely accompany the patient to clinic visits
Key exclusion criteria (1 listed)
- Significant psychiatric or other co-morbid disease
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 |
|---|---|---|
| early palliative carepatient assigned to the intervention will receive early palliative care along with standard oncology care. | Other | Early Palliative Care |
Primary outcome
Functional Assessment of Cancer Therapy (Quality of Life Measure)
Time frame: 12 weeks
The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study
7 secondary outcomes
Functional Assessment of Cancer Therapy (Quality of Life Measure)
Time frame: 24 weeks
Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale
Time frame: Week-12 and Week-24
Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer
Time frame: Week12 and Week 24
Family Caregiver Quality of Life as Measured by the SF-36
Time frame: Week-12 and Week-24
Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)
Time frame: Week 12 and Week 24
Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer
Time frame: 12 and 24 weeks
Coping (Brief Cope)
Time frame: Up to week-24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29474102Hoerger M, Greer JA, Jackson VA, Park ER, Pirl WF, El-Jawahri A, Gallagher ER, Hagan T, Jacobsen J, Perry LM, Temel JS. Defining the Elements of Early Palliative Care That Are Associated With Patient-Reported Outcomes and the Delivery of End-of-Life Care. J Clin Oncol. 2018 Apr 10;36(11):1096-1102. doi: 10.1200/JCO.2017.75.6676. Epub 2018 Feb 23.
- Derived from this study: PubMed 29140772Greer JA, Jacobs JM, El-Jawahri A, Nipp RD, Gallagher ER, Pirl WF, Park ER, Muzikansky A, Jacobsen JC, Jackson VA, Temel JS. Role of Patient Coping Strategies in Understanding the Effects of Early Palliative Care on Quality of Life and Mood. J Clin Oncol. 2018 Jan 1;36(1):53-60. doi: 10.1200/JCO.2017.73.7221. Epub 2017 Nov 15.
- Individual participant dataSharing planned: Yes. will share deidentified data with proper IRB approval
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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 early palliative care in people with Non-small Cell Lung Cancer and 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 1 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 19 Oct 2023. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Assessment of Cancer Therapy (Quality of Life Measure) (time frame: 12 weeks). 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 NCT01401907, which also lists 2 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 19 Oct 2023.