Phase 3
N=405
Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers
Liver Cancer · Anxiety Disorder · Depression · Small Cell Lung Cancer · Extrahepatic Bile Duct Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02349412 ↗Enrolled (actual)
405
Serious AEs
—
Results posted
Feb 2019
Primary outcome: Primary: Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) — 3.35; 0.12 units on a scale — p=0.104
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Early palliative care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G) |
3.35; 0.12 | 0.104 |
| SECONDARY Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G) |
3.80; 0.69 | 0.188 |
| SECONDARY Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression |
0.54; 0.46 | 0.884 |
| SECONDARY Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety |
-1.13; -0.32 | 0.033 sig |
| SECONDARY Prognostic Understanding at Week-12 as Measured by "Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying?" Question on the Prognosis and Treatment Perceptions Questionnaire |
30; 16; 69; 94 | 0.006 sig |
| SECONDARY Change in QOL on the SF-36 Over Time |
— | — |
| SECONDARY Rate of Referral, Enrollment and Length of Stay on Hospice |
— | — |
| SECONDARY Location of Death |
— | — |
| SECONDARY Number of Hospital and Intensive Care Unit (ICU) Admissions and Days |
— | — |
| SECONDARY Chemotherapy and Radiation Administration |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Concordance Between Patient and Family Caregiver Report of Prognosis/Curability |
— | — |
Summary
The study intervention consists of the early integration of palliative care services into standard oncology care in an outpatient setting for patients with advanced lung and non-colorectal gastrointestinal malignancies who are not being treated with curative intent. The palliative care services provided to patients randomized to the intervention will be provided by board-certified physicians and/or advanced practice nurses and will focus on the following areas: (1) developing and maintaining the therapeutic relationship with the patients and family caregivers; (2) assessing and treating patient symptoms; (3) providing support and reinforcement of coping with advanced cancer in patients and family caregivers; (4) assessing and enhancing prognostic awareness and illness understanding in patients and family caregivers; (5) assisting with treatment decision-making; and (6) end-of-life care planning.
Eligibility Criteria
Study Patient Participant Eligibility Requirements:
- Documentation of Disease: Confirmed advanced lung cancer (NSCLC, small cell lung cancer, or mesothelioma) or non-colorectal GI cancer (esophageal, gastric, hepatic, biliary, or pancreatic) not being treated with curative intent.
- Informed of diagnosis of incurable disease within the previous 8 weeks.
- Age ≥ 18 years
- ECOG Performance Status 0-2
- Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.
- Planning to receive all medical care for cancer at the enrolling institution.
- Participants must be under the care of an oncologist, but their current plan may or may not include chemotherapy or other forms of tumor-directed therapies.
Study Family Caregiver Participant Eligibility Requirements:
- Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits.
- Family caregiver must live with the patient or have in-person contact with him or her at least twice per week.
- Ability to read and respond to questions in English or able to complete questions with minimal assistance required from an interpreter or family member.
- Age ≥ 18 years
Note: An eligible patient may participate in this trial without an eligible family caregiver being registered.
Data sourced from ClinicalTrials.gov (NCT02349412). 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.