N/A
N=350
Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies
Non-small Cell Lung Cancer · Small Cell Lung Cancer · Mesothelioma · Esophageal Cancer · Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01401907 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Functional Assessment of Cancer Therapy (Quality of Life Measure) — 81.10; 77.70 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- early palliative care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Assessment of Cancer Therapy (Quality of Life Measure) |
81.26; 75.90 | — |
| SECONDARY Functional Assessment of Cancer Therapy (Quality of Life Measure) |
81.26; 75.90 | — |
| SECONDARY Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale |
29; 32; 24; 32 | — |
| SECONDARY Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer |
41; 50; 37; 32 | — |
| SECONDARY Family Caregiver Quality of Life as Measured by the SF-36 |
52.94; 51.40; 47.00; 45.92; 52.71; 53.22 | — |
| SECONDARY Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) |
9.02; 10.48; 9.82; 10.72 | — |
| SECONDARY Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer |
34; 40; 19; 29 | — |
| SECONDARY Coping (Brief Cope) |
0.21; -0.88 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01401907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.