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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA215188 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer
Patients with serious cancers, like advanced lung cancer, often experience physical symptoms, such as pain or shortness of breath. In addition, both patients and their loved ones (family and friends) often feel worried or sad about their cancer 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer. This team is called "palliative care," and consists of physicians and advanced practice nurses (or "nurse practitioners") who work closely and collaboratively with your oncology team to care for the participant and the participant's loved ones. Research shows that when the palliative care team works closely with the oncology team to care for patients with advanced cancer, they may have better symptom control, quality of life, and mood and their loved ones feel less distressed.
This study will compare two different strategies for scheduling participant's visits with the palliative care clinician. The first strategy is to schedule the participant to meet with the palliative care clinician regularly each month. The investigators call this strategy "early integrated palliative care".
The second strategy is to schedule the participant to meet with the palliative care clinician after the participant is admitted to the hospital or if the participant's oncology team needs to change the participant cancer treatment, as these are times when the participant is likely to have health issues that the palliative care clinician can help with. The investigators will also monitor the participant's quality of life regularly. If the study team determines that the participant quality of life worsens, the investigators will increase the frequency of the participant's visits with the palliative care clinician to monthly appointments. The investigators call this strategy "stepped palliative care" because the investigators step up the frequency of the participant palliative care visits if the participant's quality of life worsens during the participant cancer treatment.
No matter which strategy the participant is taking part in, the participant will still be able to request additional palliative care visits outside of the study schedule if the participant feel they need them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped PC | Experimental |
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| Early Integrated PC | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped PC | Other | Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Quality of Life | Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians | Compare the proportion of patients who report that they discussed their end-of-life care preferences with their clinicians based on a single item from the perceptions of prognosis and treatment questionnaire (PTPQ). The PTPQ includes an item that measures patient report of communication about their wishes if they were dying (yes vs. no). |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL | up to 5 years |
| Patients' Prognostic Understanding |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Temel, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38824442 | Derived | Temel JS, Jackson VA, El-Jawahri A, Rinaldi SP, Petrillo LA, Kumar P, McGrath KA, LeBlanc TW, Kamal AH, Jones CA, Rabideau DJ, Horick N, Pintro K, Gallagher Medeiros ER, Post KE, Greer JA. Stepped Palliative Care for Patients With Advanced Lung Cancer: A Randomized Clinical Trial. JAMA. 2024 Aug 13;332(6):471-481. doi: 10.1001/jama.2024.10398. | |
| 35588200 | Derived | Petrillo LA, El-Jawahri A, Heuer LB, Post K, Gallagher ER, Trotter C, Elyze M, Vyas C, Plotke R, Turk YR, Han J, Temel JS, Greer JA. Health-Related Quality of Life and Depression Symptoms in a Cross Section of Patients with Advanced Lung Cancer before and during the COVID-19 Pandemic. J Palliat Med. 2022 Nov;25(11):1639-1645. doi: 10.1089/jpm.2022.0049. Epub 2022 May 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stepped PC |
Stepped PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
| FG001 | Early Integrated PC |
Early Integrated PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stepped PC |
Stepped PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient-reported Quality of Life | Quality of life as measured by the Functional Assessment of Cancer Therapy-Lung Range 0-136 with higher scores indicating better quality of life | Posted | Mean | 95% Confidence Interval | score on a scale | 24 Weeks |
|
Up to 12 months post enrollment
No serious or other (non-serious) adverse events were collected or monitored in this supportive care trial. As a result, the total number of participants at risk for adverse events is zero since this was not monitored in this supportive care trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stepped PC |
Stepped PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Temel | Massachusetts General Hospital/Harvard Medical School | 617-724-4000 | jtemel@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2023 | Jun 13, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2024 | Jun 13, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| Early Integrated PC | Other | Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
|
| 48 weeks (or last assessment prior to death if before 48 weeks) |
| Length of Stay in Hospice | Length of stay in hospice as collected per medical record review | From hospice enrollment until death during study period (i.e. 12-month follow up) |
| Palliative Care Resource Utilization | Mean number of palliative care visits | week 24 |
Perception of Treatment and Prognosis Questionnaire (PTPQ)
| last assessment collected during study or prior to death |
| Health Care Utilization | Healthcare utilization as measured the means and proportion of patients who experience emergency department visits, hospital admission, and chemotherapy administration at the end of life between the two groups. | prior to death or end of study period |
| Durham |
| North Carolina |
| 27710 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| 35144954 | Derived | Post KE, Heuer LB, Kamal AH, Kumar P, Elyze M, Griffith S, Han J, Friedman F, Jackson A, Trotter C, Plotke R, Vyas C, Jackson V, Rabideau DJ, Greer JA, Temel JS. Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer. BMJ Open. 2022 Feb 10;12(2):e057591. doi: 10.1136/bmjopen-2021-057591. |
| BG001 | Early Integrated PC |
Early Integrated PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Functional Assessment of Cancer Therapy - Lung | Range 0-136 with higher scores indicating better quality of life | Mean | Standard Deviation | units on a scale |
|
| OG001 | Early Integrated PC |
Early Integrated PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer |
|
|
|
| Secondary | Proportion of Patients Who Self-report Discussing Their End of Life Care Preferences With Their Clinicians | Compare the proportion of patients who report that they discussed their end-of-life care preferences with their clinicians based on a single item from the perceptions of prognosis and treatment questionnaire (PTPQ). The PTPQ includes an item that measures patient report of communication about their wishes if they were dying (yes vs. no). | Posted | Count of Participants | Participants | 48 weeks (or last assessment prior to death if before 48 weeks) |
|
|
|
|
| Secondary | Length of Stay in Hospice | Length of stay in hospice as collected per medical record review | Posted | Mean | Standard Deviation | days | From hospice enrollment until death during study period (i.e. 12-month follow up) |
|
|
|
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| Secondary | Palliative Care Resource Utilization | Mean number of palliative care visits | Posted | Mean | Standard Deviation | days | week 24 |
|
|
|
|
| Other Pre-specified | Cost-effectiveness | Cost effectiveness as assessed by data collection from the medical record, hospital cost accounting systems, and patient report as per the EuroQOL | Not Posted | Dec 2025 | up to 5 years | Participants |
| Other Pre-specified | Patients' Prognostic Understanding | Perception of Treatment and Prognosis Questionnaire (PTPQ) | Not Posted | last assessment collected during study or prior to death | Participants |
| Other Pre-specified | Health Care Utilization | Healthcare utilization as measured the means and proportion of patients who experience emergency department visits, hospital admission, and chemotherapy administration at the end of life between the two groups. | Not Posted | Dec 2026 | prior to death or end of study period | Participants |
| 161 |
| 250 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Early Integrated PC |
Early Integrated PC: Palliative Care is 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 family cope with a serious illness improves patients' and their loved ones' experience with their cancer | 164 | 257 | 0 | 0 | 0 | 0 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Pre-specified margin of -10%.