Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401907
• Other study ID #: 10-434
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: December 2019

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The study will use questionnaires to measure patients' and caregivers' quality of life, mood, coping and understanding of their illness.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: December 2019
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Significant psychiatric or other co-morbid disease

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastric Cancer
• Liver Cancer
• Lung Neoplasms
• Mesothelioma
• Non-small Cell Lung Cancer
• Pancreatic Cancer
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Other:
• early palliative care
patient assigned to the intervention will receive early palliative care along with standard oncology care.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 weeks
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.	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.	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.	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.	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	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.	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	Up to week-24