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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459002
• Other study ID #: 2012-0405
• Secondary ID: NCI-2019-02352
• Status: Completed
• Start date: July 18, 2012
• Est. completion date: March 13, 2023

Study information

• Verified date: March 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: March 13, 2023
• Est. primary completion date: March 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Behavioral:
• QOL Questionnaire
Participant outcomes assessed with survey
• Caregiver Satisfaction Questionnaire
Caregiver satisfaction with quality of care assessed with surveys

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Caregiver Outcomes: FAMCARE Scale	Caregiver satisfaction with quality of care assessed with FAMCARE validated 12-item survey, which measures the degree of satisfaction with health care in terms of information provided, availability of care, physical individual with advanced cancer care, and psychological care.	Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks

External Links

•   University of Texas MD Anderson Cancer Center Official Website