Lung CancerNCT02459002
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
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to learn about the quality of life (QOL) in participants with advanced lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- QOL Questionnaire and Caregiver Satisfaction Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2012to 13 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center Non-small cell lung cancer (NSCLC) patients
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
The goal of this study is to learn about the quality of life (QOL) in participants with advanced lung cancer.
Read the 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:
- 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
- Being tested
- QOL Questionnaire, Caregiver Satisfaction Questionnaire
- Keywords
- Advanced lung cancer, NSCLC, palliative care
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QOL QuestionnaireBehavioural
Also called survey
Participant outcomes assessed with survey
Caregiver Satisfaction QuestionnaireBehavioural
Also called survey
Caregiver satisfaction with quality of care assessed with surveys
| Study group | Role | What they receive |
|---|---|---|
| NSCLC - Current Palliative Care Referral Practices | Early palliative consultation impact assessment via questionnaires during a regularly scheduled clinic visit or during inpatient stay. Receives: 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. Receives: 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. Receives: Behavioral: QOL Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start18 Jul 2012
- Primary completion13 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siriam Yennu, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459002
- Sponsor's protocol ID
- 2012-0405
- Other IDs
- NCI-2019-02352
- Status last verified
- Mar 2023
- First submitted
- 28 May 2015
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02459002
- Acronym / sponsor ID
- 2012-0405
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- Advanced lung cancer, NSCLC, palliative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Jul 2012 (actual)
- Primary completion
- 13 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSCLC - Current Palliative Care Referral Practices | – | Behavioral: QOL QuestionnaireEarly palliative consultation impact assessment via questionnaires during a regularly scheduled clinic visit or during inpatient stay. |
| Primary Caregiver | – | Behavioral: Caregiver Satisfaction QuestionnaireCaregiver satisfaction with quality of care and early palliative consultation impact assessed via questionnaires during a regularly scheduled clinic visit or during inpatient stay. |
| NSCLC - After Early Palliative Care Consult System | – | Behavioral: QOL QuestionnairePalliative consultation impact assessment via questionnaires during a regularly scheduled clinic visit or during inpatient stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center Non-small cell lung cancer (NSCLC) patients
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QOL QuestionnaireAlso: surveyParticipant outcomes assessed with survey | Behavioural | NSCLC - After Early Palliative Care Consult System, NSCLC - Current Palliative Care Referral Practices |
| Caregiver Satisfaction QuestionnaireAlso: surveyCaregiver satisfaction with quality of care assessed with surveys | Behavioural | Primary Caregiver |
Primary outcome
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.
1 secondary outcome
Caregiver Outcomes: FAMCARE Scale
Time frame: Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siriam Yennu, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non-small Cell Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' QOL Assessments (time frame: Baseline till participant death or end of follow-up period, assessed every 4 weeks for approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.