Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Palliative Care | Experimental | Subjects receive standard of care with early palliative care. |
|
| Standard of Care | No Intervention | Subjects receives standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early palliative care | Other | patient assigned to the intervention will receive early palliative care along with standard oncology care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29474102 | Derived | 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. | |
| 29140772 |
Not provided
Not provided
will share deidentified data with proper IRB approval
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Early Palliative Care | Subjects receive standard of care with early palliative care. early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care. |
| FG001 | Standard of Care | Subjects receives standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Early Palliative Care | Subjects receive standard of care with early palliative care. early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care. |
| BG001 | Standard of Care |
| 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 | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
6 months
no AE from this non-medication/treatment study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Early Palliative Care | Subjects receive standard of care with early palliative care. early palliative care: patient assigned to the intervention will receive early palliative care along with standard oncology care. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Temel MD | MGH | 617-724-4000 | jtemel@partners.org |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D008654 | Mesothelioma |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
early palliative care
Not provided
Not provided
Not provided
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. |
| 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. | 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. | 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 | 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. | 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 | Up to week-24 |
| Greer 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. |
Subjects receives standard of care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm) | Posted | Mean | 95% Confidence Interval | units on a scale | 24 weeks |
|
|
|
| Secondary | 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. | The two rows examine outcomes at two different time points week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart. | Posted | Count of Participants | Participants | Week-12 and Week-24 |
|
|
|
| Secondary | 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. | The different rows reflect analyses at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the Perception of Treatment and Prognosis Questionnaire at these time points (study completers), which explains the discrepancy with the flow chart. | Posted | Count of Participants | Participants | Week12 and Week 24 |
|
|
|
| Secondary | 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. | Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart. | Posted | Mean | 95% Confidence Interval | units on a scale | Week-12 and Week-24 |
|
|
|
| Secondary | 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 | Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart. | Posted | Mean | 95% Confidence Interval | units on a scale | Week 12 and Week 24 |
|
|
|
| Secondary | 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. | Proportion of caregiver goal is cure at week-12 and week-24. Please note the number of participants reflect those who completed the Perception of Treatment and Prognosis Questionnaire at week-12 and week-24, which explains the discrepancy with the participants flow. | Posted | Count of Participants | Participants | 12 and 24 weeks |
|
|
|
| Secondary | 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 | Posted | Mean | 95% Confidence Interval | units on a scale | Up to week-24 |
|
|
|
| 27 |
| 175 |
| 0 |
| 175 |
| 0 |
| 175 |
| EG001 | Standard of Care | Subjects receives standard of care | 32 | 175 | 0 | 175 | 0 | 175 |
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| Week-24 |
|
|
| Goal Cure Week-24 |
|
|
| SF36 MCS Week-12 |
|
|
| SF36 PCS Week-24 |
|
|
| SF36 MCS Week-24 |
|
|
| HADS-Total Week-24 |
|
|
| Goal Cure Week-24 |
|
|