Clinical trial NCT02459002: Prospective Study to Determine Impact of Early Palliative Care Consult on Quality of Life (QOL), Cancer Related Symptoms In Advanced Lung Cancer Patients: Thoracic Pilot Project
Official title: Prospective Study to Determine Impact of Early Palliative Care Consult on Quality of Life (QOL), Cancer Related Symptoms In Advanced Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Keywords: Advanced lung cancer
NSCLC
palliative care
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center Non-small cell lung cancer (NSCLC) patients

Brief summary: The goal of this study is to learn about the quality of life (QOL) in participants with advanced lung cancer.

Detailed description: Advanced lung cancer (ALC) will be assessed for participant outcomes in a sample which is prior initiation of palliative consultation and in a sample after the initiation of early palliative consultation.

Study goals are:

I. To determine the differences in participant outcomes including quality of life (QOL); symptom distress \[Edmonton symptom assessment scale (ESAS)\] and caregiver outcomes \[Zarit Burden Interview {ZBI}, Hospital Anxiety and Depression scale(HADS) and FAMCARE\] at week 12 in advanced lung cancer (ALC) patients receiving early palliative care consultation versus those who don't.

II. Identify the cellular, molecular, and immune basis for the development of symptoms in patients with ALC.

Eligibility criteria: Inclusion Criteria:

1. Have a diagnoses of advanced NSCLC (defined as locally advanced or metastatic)
2. Have no clinical evidence of cognitive failure, as evidenced by a Memorial Delirium Assessment Score of less than or equal to 7 of 30 ⁭at the time of consent.
3. Be at least 18 years of age.
4. Be able to understand the description of the project and give written informed consent.
5. Plan to receive their cancer treatment at MD Anderson Cancer Center.
6. Individuals with advanced cancer who are able to identify a primary caregiver who also agrees to participate (in person or by telephone) in the study. A caregiver will be defined as a spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living.

Exclusion Criteria:

1. Patients to be excluded from the study will be those unable to complete the baseline assessment forms or to understand the recommendations for participation in this project.
2. Patients seen at the Thoracic center at UT MD Anderson Cancer Center after 8 weeks of the initial diagnosis (first cohort only - patients using the current Palliative Care referral practices prior to the implementation of the early palliative care program).

Primary outcomes:
measure: Participants' QOL Assessments
timeFrame: Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks
Secondary outcomes:
measure: Caregiver Outcomes: FAMCARE Scale
timeFrame: Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Siriam Yennu, MD
role: STUDY_CHAIR
References: