Lung CancerNCT00827333
Palliative Care Teaching Sessions for Family Caregivers of Patients With Non-Small Cell Lung Cancer
A study testing educational intervention, questionnaire administration and end-of-life treatment/management in people with Lung Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- educational intervention, questionnaire administration and end-of-life treatment/management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2014
- 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
- The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2
- Patients having been accrued to project 1 or project 2
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients
RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- Test the effects of a family caregiver palliative care intervention (FCPCI) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (FC) in a usual care situation.
II. Test the effects of a FCPCI for informal caregivers of patients with early and late stage lung cancer on FC in a usual care situation.
III. Describe early and late stage FC self care behavior, comparing the usual care and FCPCI groups.
IV. Describe resource use by early and late stage FC comparing the usual care and FCPCI groups. V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
- Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
OUTLINE: Family caregivers (FC) are assigned to 1 of 2 groups.
GROUP I: FC complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use.
GROUP II: FC undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of FC distress; social and spiritual needs of the patient and FC; the continuing role of the FC in caring for the patient; and development of a personalized wellness plan. FC then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. FC also complete questionnaires as in group I.
After completion of the educational intervention, a sample of FC undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.
- Conditions
- Lung Cancer
- Being tested
- educational intervention, questionnaire administration, end-of-life treatment/management, psychosocial assessment and care, quality-of-life assessment
- Keywords
- recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- 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.
educational interventionOther
Family Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment
questionnaire administrationOther
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
end-of-life treatment/managementProcedure or surgery
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
psychosocial assessment and careProcedure or surgery
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
quality-of-life assessmentProcedure or surgery
Occurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment
| Study group | Role | What they receive |
|---|---|---|
| Phase I-Usual Care | No intervention | Not described |
| Phase 2 - Intervention | Active comparator | Not described Receives: Other: educational intervention; Other: questionnaire administration; Procedure: end-of-life treatment/management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver burden
Measured: 24 weeks post study enrollment
Caregiver skills preparedness
Measured: 24 weeks post study enrollment
Caregiver quality of life
Measured: 24 weeks post study enrollment
Caregiver psychological distress
Measured: 24 weeks post study enrollment
Caregiver self-care behavior
Measured: 24 weeks post study enrollment
Resource use by caregiver
Measured: 24 weeks post study enrollment
Identification of a subgroup of caregivers who benefit most from the family caregiver palliative care intervention in relation to sociodemographic characteristics and clinical/functional factors
Measured: 24 weeks post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2014
- Study completionSep 2014
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 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
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Betty Ferrell, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827333
- Sponsor's protocol ID
- 08036
- Other IDs
- P01CA136396, P30CA033572, CHNMC-08036, CDR0000631261
- Status last verified
- Jul 2016
- First submitted
- 21 Jan 2009
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care for Quality of Life and Symptom Concerns in Family Caregivers of Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00827333
- Acronym / sponsor ID
- 08036
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Jan 2009 (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.
RATIONALE: Palliative care teaching sessions may be more effective than standard care in improving caregiver burden, caregiver skills preparedness, quality of life, and distress in family caregivers of patients with non-small cell lung cancer.
PURPOSE: This clinical trial is studying the effects of palliative care teaching sessions in family caregivers of patients with non-small cell lung cancer.
Detailed description
OBJECTIVES:
- Test the effects of a family caregiver palliative care intervention (FCPCI) for informal caregivers of patients with early and late stage lung cancer on caregiver burden and caregiver skills preparedness as compared to a group of family caregivers (FC) in a usual care situation.
II. Test the effects of a FCPCI for informal caregivers of patients with early and late stage lung cancer on FC in a usual care situation.
III. Describe early and late stage FC self care behavior, comparing the usual care and FCPCI groups.
IV. Describe resource use by early and late stage FC comparing the usual care and FCPCI groups. V. Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
- Identify subgroups of FC who benefit most from the FCPCI in relation to sociodemographic characteristics, clinical/functional factors.
OUTLINE: Family caregivers (FC) are assigned to 1 of 2 groups.
GROUP I: FC complete questionnaires at baseline and at 7, 12, 18, and 24 weeks to assess caregiver burden, caregiver skills preparedness, quality of life, distress, self care, and resource use.
GROUP II: FC undergo 4 individualized teaching sessions in weeks 7, 8, 10, and 12 that focus on caregiver burden; caregiver skills preparedness; management of patient psychological symptoms; management of FC distress; social and spiritual needs of the patient and FC; the continuing role of the FC in caring for the patient; and development of a personalized wellness plan. FC then receive 3 follow-up phone calls in weeks 16, 20, and 24 to review any questions regarding care; to assess symptom management, community resources, and support; and to review and support the wellness plan. FC also complete questionnaires as in group I.
After completion of the educational intervention, a sample of FC undergo 1-hour educational interviews exploring their perspective and insights on their experience as a caregiver.
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 | No intervention | – |
| Phase 2 - Intervention | Active comparator | Other: educational intervention, Other: questionnaire administration, Procedure: end-of-life treatment/management, Procedure: psychosocial assessment and care, Procedure: quality-of-life assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The primary family caregiver as identified by a patient with early or late stage non-small cell lung cancer (NSCLC) participating in Project 1 and 2
- Patients having been accrued to project 1 or project 2
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 |
|---|---|---|
| educational interventionFamily Caregiver Palliative Care Intervention at weeks 7, 8, 10, and 12 post study enrollment | Other | Phase 2 - Intervention |
| questionnaire administrationOccurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment | Other | Phase 2 - Intervention |
| end-of-life treatment/managementOccurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment | Procedure or surgery | Phase 2 - Intervention |
| psychosocial assessment and careOccurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment | Procedure or surgery | Phase 2 - Intervention |
| quality-of-life assessmentOccurs at baseline, 7 weeks, 12 weeks, 18 weeks and 24 weeks post enrollment | Procedure or surgery | Phase 2 - Intervention |
Primary outcome
Caregiver burden
Time frame: 24 weeks post study enrollment
Caregiver skills preparedness
Time frame: 24 weeks post study enrollment
Caregiver quality of life
Time frame: 24 weeks post study enrollment
Caregiver psychological distress
Time frame: 24 weeks post study enrollment
Caregiver self-care behavior
Time frame: 24 weeks post study enrollment
Resource use by caregiver
Time frame: 24 weeks post study enrollment
Identification of a subgroup of caregivers who benefit most from the family caregiver palliative care intervention in relation to sociodemographic characteristics and clinical/functional factors
Time frame: 24 weeks post study enrollment
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 Aug 2016.
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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, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention, questionnaire administration and end-of-life treatment/management in people with Lung Cancer, run by City of Hope Medical 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 2 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 Aug 2016. 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?
Caregiver burden (time frame: 24 weeks post study enrollment). The study lists 7 primary outcomes in all. 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 2 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.