Pancreatic Cancer Research

Clinical trialNACompleted

Early Palliative Care in Advanced Lung and Gastrointestinal Malignancies

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

NCT01401907↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome
Outcome unknown
Phase
NA
Status
Completed
Study type
Interventional
Start
May 2011
Expected end
December 2019
Enrollment
351 participants
Sites
1
Primary outcomes
Functional Assessment of Cancer Therapy (Quality of Life Measure)
Sponsor
Other
Results posted
2017-07-13
Last update
19 October 2023

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Functional Assessment of Cancer Therapy (Quality of Life Measure) [12 weeks]. Mean, units on a scale (95% Confidence Interval). Early Palliative Care (n=148): 81.10 (78.11 to 82.08); Standard of Care (n=153): 77.70 (75.77 to 79.63).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Functional Assessment of Cancer Therapy (Quality of Life Measure) [24 weeks]. Mean, units on a scale (95% Confidence Interval). Early Palliative Care (n=118): 81.26 (78.89 to 83.63); Standard of Care (n=124): 75.90 (73.59 to 78.21).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale [Week-12 and Week-24]. Count Of Participants, Participants. Week-12: Early Palliative Care (n=138): 29; Standard Oncology Care (n=141): 32. Week-24: Early Palliative Care (n=138): 24; Standard Oncology Care (n=141): 32.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer [Week12 and Week 24]. Count Of Participants, Participants. Goal Cure Week-12: Early Palliative Care (n=143): 41; Standard Oncology Care (n=145): 50. Goal Cure Week-24: Early Palliative Care (n=143): 37; Standard Oncology Care (n=145): 32.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Family Caregiver Quality of Life as Measured by the SF-36 [Week-12 and Week-24]. Mean, units on a scale (95% Confidence Interval). SF36 PCS Week-12: Early Palliative Care (n=110): 52.94 (51.30 to 54.59); Standard Oncology Care (n=119): 51.40 (49.83 to 52.98). SF36 MCS Week-12: Early Palliative Care (n=110): 47.00 (45.26 to 48.74); Standard Oncology Care (n=119): 45.92 (44.25 to 47.59). SF36 PCS Week-24: Early Palliative Care (n=110): 52.71 (51.02 to 54.40); Standard Oncology Care (n=119): 53.22 (51.58 to 54.86). SF36 MCS Week-24: Early Palliative Care (n=110): 46.21 (44.09 to 48.33); Standard Oncology Care (n=119): 45.59 (44.09 to 48.33).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale) [Week 12 and Week 24]. Mean, units on a scale (95% Confidence Interval). HADS-Total Week-12: Early Palliative Care (n=110): 9.02 (8.09 to 9.96); Standard Oncology Care (n=119): 10.48 (9.58 to 11.38). HADS-Total Week-24: Early Palliative Care (n=110): 9.82 (8.65 to 10.99); Standard Oncology Care (n=119): 10.72 (8.65 to 10.99).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer [12 and 24 weeks]. Count Of Participants, Participants. Goal Cure Week-12: Early Palliative Care (n=106): 34; Standard Oncology Care (n=113): 40. Goal Cure Week-24: Early Palliative Care (n=106): 19; Standard Oncology Care (n=113): 29.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Coping (Brief Cope) [Up to week-24]. Mean, units on a scale (95% Confidence Interval). Early Palliative Care (n=118): 0.21 (-0.39 to 0.81); Standard Oncology Care (n=124): -0.88 (-1.50 to -0.27).

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