CaregiverNCT02243748
Palliative Care Intervention in Improving Symptom Control and Quality of Life in Patients With Stage II-IV Non-small Cell Lung Cancer and Their Family Caregivers
A study testing Palliative Therapy, quality-of-life assessment and questionnaire administration in people with Caregiver and Psychological Impact of Cancer and Its Treatment, run by City of Hope Medical Center at 5 sites in United States.
Trial summary
This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver, Psychological Impact of Cancer and Its Treatment, Recurrent Non-small Cell Lung Cancer
- What is being tested?
- Palliative Therapy, quality-of-life assessment and questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Feb 2015to 22 Apr 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patient eligibility criteria for entry into the project include:
- Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
- Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
- In Phase 2, subjects are also required on accrual to be referred to Palliative Care
- FCG eligibility criteria include:
- Designated by the patient as a person closely involved in their care
- Age 18 years and older
- All subjects must have the ability to understand and the willingness to sign a written informed consent
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
City of Hope Medical Center
Duarte, California, 91010
Southern California Permanente Medical Group
Irvine, California, 92618
Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
Ontario, California, 91761
Kaiser Permanente Department of Research and Evaluation
Pasadena, California, 91101
Kaiser Permanente Medical Center
Riverside, California, 92505
About this study
Official title: Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice
This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion.
Read the detailed description
PRIMARY OBJECTIVES:
- Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI) funded Program Project (P01) for dissemination to other oncology settings.
II. Determine the impact of the PCI on patient outcomes including symptom control, quality of life (QOL), and distress as compared to the usual care group.
III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver burden, caregiver distress, skills preparation and QOL as compared to the usual care group.
IV. Test the effects of the PCI on patient resource utilization as compared to the usual care group.
OUTLINE: Participants are enrolled sequentially to 1 of 2 phases.
PHASE I: Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II.
PHASE II: Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences.
In both groups, participants are followed up for 3 months.
- Conditions
- Caregiver, Psychological Impact of Cancer and Its Treatment, Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
- Being tested
- Palliative Therapy, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative TherapyOther
Also called Comfort Care, Palliative Care, Palliative Treatment, Symptom Management
Receive individualized palliative care
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Phase I (usual care) | Active comparator | Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II. Receives: Other: quality-of-life assessment; Other: questionnaire administration |
| Phase II (individualized palliative care) | Experimental | Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences. Receives: Other: Palliative Therapy; Other: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the PCI on symptom control as compared to the usual care group
The demographic and clinical characteristics as well as baseline symptom control scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Measured: Up to 3 months
Impact of the PCI on patient QOL as compared to the usual care group
The demographic and clinical characteristics as well as baseline QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Measured: Up to 3 months
Impact of the PCI on psychological distress as compared to the usual care group
The demographic and clinical characteristics as well as baseline psychological distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Measured: Up to 3 months
Impact of the PCI on caregiver burden as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver burden scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Measured: Up to 3 months
Impact of the PCI on caregiver distress as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Measured: Up to 3 months
Impact of the PCI on caregiver skills preparation as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver skills preparation scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Measured: Up to 3 months
Impact of the PCI on caregiver QOL as compared to the usual care group
The demographic and clinical characteristics as well as baseline caregiver QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Measured: Up to 3 months
Effects of the PCI on resource utilization as compared to the usual care group
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study start5 Feb 2015
- Primary completion1 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Betty Ferrell, Principal investigator, City of Hope Medical CenterHuong Nguyen, MD, Principal investigator, Kaiser Permanente Department of Research and Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243748
- Sponsor's protocol ID
- 14206
- Other IDs
- NCI-2014-01926, 14206, 1R01NR015341-01
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2014
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nguyen HQ, Cuyegkeng T, Phung TO, Jahn K, Borneman T, Macias M, Ruel N, Ferrell BR. Integration of a Palliative Care Intervention into Community Practice for Lung Cancer: A Study Protocol and Lessons Learned with Implementation. J Palliat Med. 2017 Dec;20(12):1327-1337. doi: 10.1089/jpm.2017.0143. Epub 2017 Jun 9.
PubMed 28598227
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of a Lung Cancer Palliative Care Intervention for Clinical Practice
- ClinicalTrials.gov ID
- NCT02243748
- Acronym / sponsor ID
- 14206
- Conditions
- Caregiver, Psychological Impact of Cancer and Its Treatment, Recurrent Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 18 Sep 2014 (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.
This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion.
Detailed description
PRIMARY OBJECTIVES:
- Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI) funded Program Project (P01) for dissemination to other oncology settings.
II. Determine the impact of the PCI on patient outcomes including symptom control, quality of life (QOL), and distress as compared to the usual care group.
III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver burden, caregiver distress, skills preparation and QOL as compared to the usual care group.
IV. Test the effects of the PCI on patient resource utilization as compared to the usual care group.
OUTLINE: Participants are enrolled sequentially to 1 of 2 phases.
PHASE I: Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II.
PHASE II: Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences.
In both groups, participants are followed up for 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I (usual care) | Active comparator | Other: quality-of-life assessment, Other: questionnaire administrationParticipants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II. |
| Phase II (individualized palliative care) | Experimental | Other: Palliative Therapy, Other: quality-of-life assessment, Other: questionnaire administrationParticipants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
- Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
- In Phase 2, subjects are also required on accrual to be referred to Palliative Care
- Designated by the patient as a person closely involved in their care
- Age 18 years and older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Palliative TherapyAlso: Comfort Care, Palliative Care, Palliative Treatment, Symptom ManagementReceive individualized palliative care | Other | Phase II (individualized palliative care) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Phase I (usual care), Phase II (individualized palliative care) |
| questionnaire administrationAncillary studies | Other | Phase I (usual care), Phase II (individualized palliative care) |
Primary outcome
Impact of the PCI on symptom control as compared to the usual care group
Time frame: Up to 3 months
The demographic and clinical characteristics as well as baseline symptom control scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Impact of the PCI on patient QOL as compared to the usual care group
Time frame: Up to 3 months
The demographic and clinical characteristics as well as baseline QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Impact of the PCI on psychological distress as compared to the usual care group
Time frame: Up to 3 months
The demographic and clinical characteristics as well as baseline psychological distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Impact of the PCI on caregiver burden as compared to the usual care group
Time frame: Up to 3 months
The demographic and clinical characteristics as well as baseline caregiver burden scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Impact of the PCI on caregiver distress as compared to the usual care group
Time frame: Up to 3 months
The demographic and clinical characteristics as well as baseline caregiver distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Impact of the PCI on caregiver skills preparation as compared to the usual care group
Time frame: Up to 3 months
The demographic and clinical characteristics as well as baseline caregiver skills preparation scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Impact of the PCI on caregiver QOL as compared to the usual care group
Time frame: Up to 3 months
The demographic and clinical characteristics as well as baseline caregiver QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Effects of the PCI on resource utilization as compared to the usual care group
Time frame: Up to 3 months
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 2 Oct 2026.
- Derived from this study: PubMed 28598227Nguyen HQ, Cuyegkeng T, Phung TO, Jahn K, Borneman T, Macias M, Ruel N, Ferrell BR. Integration of a Palliative Care Intervention into Community Practice for Lung Cancer: A Study Protocol and Lessons Learned with Implementation. J Palliat Med. 2017 Dec;20(12):1327-1337. doi: 10.1089/jpm.2017.0143. Epub 2017 Jun 9.
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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.
Betty Ferrell principal investigator
City of Hope Medical Center
Huong Nguyen, MD principal investigator
Kaiser Permanente Department of Research and Evaluation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Therapy, quality-of-life assessment and questionnaire administration in people with Caregiver and Psychological Impact of Cancer and Its Treatment, run by City of Hope Medical Center at 5 sites 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 8 inclusion and 0 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Impact of the PCI on symptom control as compared to the usual care group (time frame: Up to 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02243748, which also lists 1 linked publication.
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 2 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.