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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Non-small Cell Lung Cancer; Lung Cancer

Treatments: Behavioral: QOL Questionnaire; Behavioral: Caregiver Satisfaction Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT02459002

2012-0405

NCI-2019-02352 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

209 participants in 3 patient groups

NSCLC - Current Palliative Care Referral Practices

Description:

Early palliative consultation impact assessment via questionnaires during a regularly scheduled clinic visit or during inpatient stay.

Treatment:

Behavioral: QOL Questionnaire

Primary Caregiver

Description:

Caregiver satisfaction with quality of care and early palliative consultation impact assessed via questionnaires during a regularly scheduled clinic visit or during inpatient stay.

Treatment:

Behavioral: Caregiver Satisfaction Questionnaire

NSCLC - After Early Palliative Care Consult System

Description:

Palliative consultation impact assessment via questionnaires during a regularly scheduled clinic visit or during inpatient stay.

Treatment:

Behavioral: QOL Questionnaire