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

NCT ID: NCT02459002

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 209 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-18
• Study Completion Date: 2023-03-13

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.

Conditions

Lung Cancer; Non-small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NSCLC - Current Palliative Care Referral Practices

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

QOL Questionnaire

Intervention Type: BEHAVIORAL

Participant outcomes assessed with survey

Primary Caregiver

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

Caregiver Satisfaction Questionnaire

Intervention Type: BEHAVIORAL

Caregiver satisfaction with quality of care assessed with surveys

NSCLC - After Early Palliative Care Consult System

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

QOL Questionnaire

Intervention Type: BEHAVIORAL

Participant outcomes assessed with survey

Interventions

QOL Questionnaire

Participant outcomes assessed with survey

Intervention Type: BEHAVIORAL

Caregiver Satisfaction Questionnaire

Caregiver satisfaction with quality of care assessed with surveys

Intervention Type: BEHAVIORAL

Other Intervention Names

survey; survey

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siriam Yennu, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Official Website

Other Identifiers

NCI-2019-02352

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-0405

Identifier Type: -

Identifier Source: org_study_id