Lung CancerNCT01883986
Supportive Care for Patients Newly Diagnosed With Lung Cancer
A study testing Palliative Care in people with Lung Cancer, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The aims of this project are to assess the feasibility of recruiting patients and delivering a nurse-led telephone based palliative care intervention for patients with newly diagnosed lung cancer and to assess if among patients with newly diagnosed lung cancer, the investigators can estimate the effect of a nurse-led… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Palliative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed at the Puget Sound Health Care System with a primary diagnosis of lung cancer,
- any cell type or stage,
- diagnosed within 8 weeks of study enrollment.
- Must have telephone access,
- ability of understand English and
- provide informed consent.
Who cannot join
- Patients not eligible to participate in the study include those who are inpatients prior to randomization,
- those who are under the care of palliative care or hospice at the time of randomization,
- those who have severe mental health disorders,
- those who are unable to speak directly with the nurse over the telephone,
- or those that have the inability to provide informed consent. Investigators will recruit individuals (n=40) with lung cancer over a 12 month period.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Palliative Care Interventions for Outpatients With Newly Diagnosed Lung Cancer
The aims of this project are to assess the feasibility of recruiting patients and delivering a nurse-led telephone based palliative care intervention for patients with newly diagnosed lung cancer and to assess if among patients with newly diagnosed lung cancer, the investigators can estimate the effect of a nurse-led telephone based palliative care intervention on quality-of-life, symptom burden and patient satisfaction.
Read the detailed description
Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcomes measures will be collected at baseline, and 3 months.
The study will be performed at the VA Puget Sound Health Care System. The investigators will recruit individuals (n=40) with lung cancer over 1 year. The primary objective is to test the feasibility and acceptability of the intervention, and recruitment of subjects. The investigators will estimate the effect of a nurse-led telephone based palliative care intervention to improve quality-of-life, symptom burden and patient satisfaction. In addition, using validated instruments, the investigators will assess the potential effect size of the intervention on quality of provider communication and on clinician knowledge of patient preferences for life sustaining therapies. The results of this pilot study will inform a future randomized clinical trial to test the efficacy of the intervention on a larger scale.
- Conditions
- Lung Cancer
- Being tested
- Palliative Care
- Keywords
- palliative care
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareBehavioural
Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer. Receives: Behavioral: Palliative Care |
| Usual Care | No intervention | Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months
Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.
Measured: Baseline and 3 months
Secondary outcomes (3)
Change From Baseline in Patient Satisfaction of Care at 3 Months
Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total scores are reported (no subscales). The total scores range from 13-65 with scores of 52 > indicating satisfaction with care. The higher the score the better the outcome (better satisfaction with care). In full randomized clinical trials, the estimated minimal important difference is 5 points from baseline to 12 weeks.
Measured: Baseline and 3 months
Change in Baseline Quality of Clinician Communication at 3 Months
The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).The QOC consists of 13 items divided into two subscales, six general communication items and seven end-of-life topics. We analyzed the six-item "general communication skills" scale, which scores range from 0-10. The higher the score the better the provider's communication is. We asked patients to answer the questions in reference to the provider who was primarily responsible for managing their lung cancer.
Measured: Baseline and 3 months
Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months
Clinician knowledge of patient preferences for life sustaining treatments will be assessed at baseline and at the study end point by asking 2 validated questions to both the clinician and the patient and determining the level of agreement between the responses.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lynn F. Reinke, PhD ARNP, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883986
- Sponsor's protocol ID
- NRI 12-141
- Status last verified
- Dec 2016
- First submitted
- 18 Jun 2013
- Last updated
- 31 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Interventions for Outpatients With Newly Diagnosed Lung Cancer
- ClinicalTrials.gov ID
- NCT01883986
- Acronym / sponsor ID
- NRI 12-141
- Conditions
- Lung Cancer
- Keywords
- palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 31 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this project are to assess the feasibility of recruiting patients and delivering a nurse-led telephone based palliative care intervention for patients with newly diagnosed lung cancer and to assess if among patients with newly diagnosed lung cancer, the investigators can estimate the effect of a nurse-led telephone based palliative care intervention on quality-of-life, symptom burden and patient satisfaction.
Detailed description
Patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care or the usual care arm. Patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. Outcomes measures will be collected at baseline, and 3 months.
The study will be performed at the VA Puget Sound Health Care System. The investigators will recruit individuals (n=40) with lung cancer over 1 year. The primary objective is to test the feasibility and acceptability of the intervention, and recruitment of subjects. The investigators will estimate the effect of a nurse-led telephone based palliative care intervention to improve quality-of-life, symptom burden and patient satisfaction. In addition, using validated instruments, the investigators will assess the potential effect size of the intervention on quality of provider communication and on clinician knowledge of patient preferences for life sustaining therapies. The results of this pilot study will inform a future randomized clinical trial to test the efficacy of the intervention on a larger scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Palliative CareThis is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer. |
| Usual Care | No intervention | –Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed at the Puget Sound Health Care System with a primary diagnosis of lung cancer,
- any cell type or stage,
- diagnosed within 8 weeks of study enrollment.
- Must have telephone access,
- ability of understand English and
Key exclusion criteria (5 listed)
- Patients not eligible to participate in the study include those who are inpatients prior to randomization,
- those who are under the care of palliative care or hospice at the time of randomization,
- those who have severe mental health disorders,
- those who are unable to speak directly with the nurse over the telephone,
- or those that have the inability to provide informed consent. Investigators will recruit individuals (n=40) with lung cancer over a 12 month period.
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 CareCare delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient. | Behavioural | Intervention |
Primary outcome
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months
Time frame: Baseline and 3 months
Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.
3 secondary outcomes
Change From Baseline in Patient Satisfaction of Care at 3 Months
Time frame: Baseline and 3 months
Change in Baseline Quality of Clinician Communication at 3 Months
Time frame: Baseline and 3 months
Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lynn F. Reinke, PhD ARNP principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care in people with Lung Cancer, run by VA Office of Research and Development 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 5 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 31 Jan 2017. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months (time frame: Baseline and 3 months). 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 31 Jan 2017.