Lung CancerNCT03220100
Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL
A study testing Stepped Palliative Care in people with Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is evaluating a new way to provide palliative care to patients who have recently been diagnosed with lung cancer. . Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Stepped Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2017to 29 Jan 2018
- 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
- Diagnosed with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed <50% of the day)
- The ability to read and respond to questions in English or with minimal help from a family member or medical interpreter.
- Primary cancer care at the MGH Cancer Center
- Age > 18 years
Who cannot join
- They are already receiving PC or hospice services
- They have cognitive or psychiatric conditions as determined by the treating oncologist that prohibits study consent or participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: Pilot Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL
This research study is evaluating a new way to provide palliative care to patients who have recently been diagnosed with lung cancer. . Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
Read the detailed description
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. Both patients and their families often feel worried and/or sad about this diagnosis. Research has shown that early involvement of a team of clinicians that specialize in lessening (or palliating) many of these distressing physical and emotional symptoms, and in helping patients and their families' cope with serious illnesses, improves patients' quality of life and mood, and can help their loved ones' feel less depressed or sad. This team is called "palliative care," and consists of physicians and advanced practice nurses who work closely and collaboratively with the oncology team to care for the patient and their loved ones.
While the investigators know having palliative care clinicians care for patients along with their oncology team is helpful for the participant and their loved ones, the investigators do not know the optimal timing of the visits with palliative care.
The purpose of this study is to see if the investigators can closely monitor participants' health condition and quality of life and use these metrics as indications of when the participant should see the palliative care team.
This study will monitor participants' health condition and schedule the participant to see the palliative care team if the participants' cancer grows or after the participant have been admitted to the hospital. The investigators will also monitor participants' quality of life every six weeks and schedule the participant to see the palliative care monthly if the participant quality of life decreases during the study.
This study will also monitor participants' mood, coping, and understanding of the participant illness and prognosis. The investigators will ask the participant to fill out questionnaires asking about these topics every 12 weeks. The participant will be able to complete these questionnaires in clinic, via email, using a mailed paper copy, or over the phone with a member of the research team.
- Conditions
- Lung Cancer
- Being tested
- Stepped Palliative Care
- Keywords
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped Palliative CareOther
Palliative care clinicians will develop a therapeutic relationship with participants and address their symptoms, coping, prognostic awareness and illness understanding, treatment decision-making, and end of life care needs and preferences.
| Study group | Role | What they receive |
|---|---|---|
| Stepped Palliative Care | Experimental | All participants will receive palliative care Participants will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) every six weeks FACT-L scores will be used to determine which patients need to step up to every 6 week palliative care visits Patients on step 1 of the intervention will have a palliative care visit every 9 weeks Patients on step 2 of the intervention will have a palliative care visit every 6 weeks Receives: Other: Stepped Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who complete the study protocol
The investigators will determine that the study protocol is feasible if at least 75% of participants on step 2 of the intervention complete at least 70% of the scheduled palliative care visits.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start18 Jul 2017
- Primary completion22 Jan 2018
- Study completion29 Jan 2018
Why it stopped: Received funding for larger randomized study so terminated pilot study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT03220100
- Sponsor's protocol ID
- 17-284
- Status last verified
- Mar 2019
- First submitted
- 10 Jul 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Stepped Palliative Care in Patients With Advanced Lung Cancer DF/HCC SOCIAL-BEHAVIORAL RESERACH PROTOCOL
- ClinicalTrials.gov ID
- NCT03220100
- Acronym / sponsor ID
- 17-284
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Received funding for larger randomized study so terminated pilot study
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 18 Jul 2017 (actual)
- 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.
This research study is evaluating a new way to provide palliative care to patients who have recently been diagnosed with lung cancer. . Palliative care is a medical specialty focused on lessening (or "palliating") patients' symptoms and helping patients and their families cope with a serious illness.
Detailed description
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. Both patients and their families often feel worried and/or sad about this diagnosis. Research has shown that early involvement of a team of clinicians that specialize in lessening (or palliating) many of these distressing physical and emotional symptoms, and in helping patients and their families' cope with serious illnesses, improves patients' quality of life and mood, and can help their loved ones' feel less depressed or sad. This team is called "palliative care," and consists of physicians and advanced practice nurses who work closely and collaboratively with the oncology team to care for the patient and their loved ones.
While the investigators know having palliative care clinicians care for patients along with their oncology team is helpful for the participant and their loved ones, the investigators do not know the optimal timing of the visits with palliative care.
The purpose of this study is to see if the investigators can closely monitor participants' health condition and quality of life and use these metrics as indications of when the participant should see the palliative care team.
This study will monitor participants' health condition and schedule the participant to see the palliative care team if the participants' cancer grows or after the participant have been admitted to the hospital. The investigators will also monitor participants' quality of life every six weeks and schedule the participant to see the palliative care monthly if the participant quality of life decreases during the study.
This study will also monitor participants' mood, coping, and understanding of the participant illness and prognosis. The investigators will ask the participant to fill out questionnaires asking about these topics every 12 weeks. The participant will be able to complete these questionnaires in clinic, via email, using a mailed paper copy, or over the phone with a member of the research team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stepped Palliative Care | Experimental | Other: Stepped Palliative CareAll participants will receive palliative care Participants will complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) every six weeks FACT-L scores will be used to determine which patients need to step up to every 6 week palliative care visits Patients on step 1 of the intervention will have a palliative care visit every 9 weeks Patients on step 2 of the intervention will have a palliative care visit every 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma, being treated with non-curative intent, and informed of advanced disease within the prior eight weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 2 (symptomatic and in bed <50% of the day)
- The ability to read and respond to questions in English or with minimal help from a family member or medical interpreter.
- Primary cancer care at the MGH Cancer Center
- Age > 18 years
Key exclusion criteria (2 listed)
- They are already receiving PC or hospice services
- They have cognitive or psychiatric conditions as determined by the treating oncologist that prohibits study consent or participation
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 |
|---|---|---|
| Stepped Palliative CarePalliative care clinicians will develop a therapeutic relationship with participants and address their symptoms, coping, prognostic awareness and illness understanding, treatment decision-making, and end of life care needs and preferences. | Other | Stepped Palliative Care |
Primary outcome
Proportion of participants who complete the study protocol
Time frame: 2 years
The investigators will determine that the study protocol is feasible if at least 75% of participants on step 2 of the intervention complete at least 70% of the scheduled palliative care visits.
Results and safety
The study was stopped early (reason given: Received funding for larger randomized study so terminated pilot study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Individual participant dataSharing planned: No
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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 Stepped Palliative Care in people with 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: stopped early, as of the sponsor's last update on 8 Mar 2019. 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 was stopped early (reason given: Received funding for larger randomized study so terminated pilot study). Results are not available in the source record.
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?
Proportion of participants who complete the study protocol (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2019.