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

NCT02459002 | Completed

• 2 other identifiers: 2012-0405NCI-2019-02352
• Study Type: observational
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer; Non-small Cell Lung Cancer

Keywords

Advanced lung cancer; NSCLC; palliative care

Outcome Measures

Primary Outcomes (1)

• Participants' QOL Assessments

  Impact of early palliative consultation (defined as palliative consultation within 8 weeks of initial advanced cancer diagnosis) on participant outcomes including improvement QOL \[FACT-L trial outcome index \[TOI\] score)\]. QOL assessed with FACT-L instrument, widely used to assess QOL of advanced NSCLC. FACT-L consists of 4 general \& 1 lung cancer symptom-specific subscale. General subscales include physical well-being (PWB; seven items), social/family well-being (seven items), emotional well-being (five items), and functional well-being (FWB; seven items). The seven-item lung cancer subscale (LCS) assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, loss of weight, tightness in chest). The 21-item TOI (Trial Outcome Index) is derived by adding PWB, FWB, and LCS scores. All FACT-L items are rated on five-point scales ranging from 0 for "not at all" to 4 for "very much." Higher scores are representative of better QOL or fewer symptoms.

  Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks

Secondary Outcomes (1)

• Caregiver Outcomes: FAMCARE Scale

  Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks

Study Arms (3)

NSCLC - Current Palliative Care Referral Practices

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

Behavioral: QOL Questionnaire

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.

Behavioral: Caregiver Satisfaction Questionnaire

NSCLC - After Early Palliative Care Consult System

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

Behavioral: QOL Questionnaire

Interventions

QOL Questionnaire BEHAVIORAL

Participant outcomes assessed with survey

Also known as: survey

NSCLC - After Early Palliative Care Consult System; NSCLC - Current Palliative Care Referral Practices

Caregiver Satisfaction Questionnaire BEHAVIORAL

Caregiver satisfaction with quality of care assessed with surveys

Also known as: survey

Primary Caregiver

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MD Anderson Cancer Center Non-small cell lung cancer (NSCLC) patients

You may qualify if:

• Have a diagnoses of advanced NSCLC (defined as locally advanced or metastatic)
• 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.
• Be at least 18 years of age.
• Be able to understand the description of the project and give written informed consent.
• Plan to receive their cancer treatment at MD Anderson Cancer Center.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens drawn (24 mL (8 mL x 3) at the following timepoints: baseline, every 4 weeks (+ 5 days) until end of follow-up.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Siriam Yennu, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: July 18, 2012
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

US (1)