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

March 14, 2023 updated by: M.D. Anderson Cancer Center

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Participant outcomes assessed with survey
Other Names:
  • 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.
Behavioral: Caregiver Satisfaction Questionnaire
Caregiver satisfaction with quality of care assessed with surveys
Other Names:
  • survey
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
Participant outcomes assessed with survey
Other Names:
  • survey

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Siriam Yennu, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-0405
  • NCI-2019-02352 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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