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NCT Number: 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

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

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

QOL Questionnaire

Behavioral

Participant outcomes assessed with survey

Other names: survey

Caregiver Satisfaction Questionnaire

Behavioral

Caregiver satisfaction with quality of care assessed with surveys

Other names: survey

Primary outcomes

  1. Participants' QOL Assessments

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

    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.

Secondary outcomes

  1. Caregiver Outcomes: FAMCARE Scale

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

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Prospective Study to Determine Impact of Early Palliative Care Consult on Quality of Life (QOL), Cancer Related Symptoms In Advanced Lung Cancer Patients

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2015
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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