CancerNCT00579215
Lung Cancer Informational Study (LCIS)
A study testing Enhance Care in people with Cancer and Enhanced Care, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate a new program to help the patient and the caregiver make decisions about treatment for lung cancer. We need to know if a new information program is helpful to patients. The way that we will do this is by comparing it with the usual information program that we now provide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Enhanced Care, Decision-Making
- What is being tested?
- Enhance Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2006to Mar 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathologically or cytologically determined non-small cell lung cancer
- Stage IIIA, IIIB or IV extent
- No prior chemotherapy unless used in adjuvant therapy, completed more than two years ago, and no sign of any other malignancy active at this time
- Lung cancer-directed treatment with a standard or investigative chemotherapy regimen at entry
- Patients with brain metastasis are acceptable provided they are at least 3 weeks from completion of radiation therapy for brain metastasis, have stable and acceptable neurological status, and meet all other eligibility criteria. For patients undergoing gamma knife procedure, cognitive ability is the judgment call of the oncologist and study nurse as to whether comprehension is not a problem.
Who cannot join
- Performance status of KPS 60-100% or ECOG 0-2;
- No age limit
- Life expectancy greater than three months
- A caregiver (any family member or concerned other who consistently provides emotional and/or physical support) available to also participate
- Patient and caregiver are able to understand English (ability to repeat back in their own words)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia- School of Nursing
Charlottesville, Virginia, 22908
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to evaluate a new program to help the patient and the caregiver make decisions about treatment for lung cancer. We need to know if a new information program is helpful to patients. The way that we will do this is by comparing it with the usual information program that we now provide.
Patient are asked to make difficult decisions about their treatments. These decisions may include when to change treatments or when to stop treatment altogether. Most patients ask a family member or close friend to help them with these difficult decisions. A "caregiver" is someone they can count on to give support (either emotional or physical) over a period of time. The doctors and nurses will also help patients and their caregiver to make these decisions.
They will tell them the risks with each treatment, the success with each treatment, and how much time there is for making each decision.
Read the detailed description
Many patients with advanced lung cancer and their caregivers struggle with treatment decisions, such as when to say "enough." Patient preparation for facing termination of cancer-directed therapy for the number one cause of cancer mortality for both men and women in the U.S. is not well handled in most clinical practices. Sparse literature validates that this concern is often denied by investigators. Failure to engage in a systematic, informed decision-making process, even in the initial stage of treatment, may often result in patients looking back and saying, "Knowing what I know now, I wouldn't make the same choice" The long-term goal of this program of research is to enhance patient care for lung cancer by oncology health professionals and to promote patient empowerment to make informed choices, defined as the ability to actively understand and influence one's health status. For this study, shared decision making is defined as a tailored, interactive process (emphasizing beliefs/personal values) in which the patient is informed enough to ask pertinent questions and to participate in the final decision at his/her own preference and comfort levels. The intent is to test a decision aid for patients with advanced lung cancer to help facilitate informed decisions about treatments that affect quality of life, including termination of cancer-directed treatment.
- Conditions
- Cancer, Enhanced Care, Decision-Making, Advance Lung Cancer, Stage III Lung Cancer, Stage IV Lung Cancer
- Being tested
- Enhance Care, Usual Care
- Keywords
- Cancer, Enhanced Care, Decision-Making, Advance Lung Cancer, Questionaires, Stage III Lung Cancer, Stage IV Lung Cancer
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhance CareBehavioural
Also called EC
EC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits
Usual CareBehavioural
As an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making. Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Enhance Care (EC) will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits. Receives: Behavioral: Enhance Care |
| 2 | Other | As an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making. Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of implementing a short, clinic-based, decision-making aid (cognitive-behavioral skills intervention) for patients with advanced lung cancer (and their caregivers) facing cancer-directed treatment.
Measured: 2 years
Secondary outcomes (1)
To gather data for testing the hypothesis that patients with advanced lung cancer who receive a decision aid will report increased quality decision making, and decreased decisional conflict at the end of Decision 3 compared to the usual care group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startNov 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Virginia, National Institute of Nursing Research (NINR)
- Investigators
- Leslie B Tyson, NO, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579215
- Sponsor's protocol ID
- 06-141
- Status last verified
- Mar 2009
- First submitted
- 20 Dec 2007
- Last updated
- 18 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Informational Study (LCIS)
- ClinicalTrials.gov ID
- NCT00579215
- Acronym / sponsor ID
- 06-141
- Conditions
- Cancer, Enhanced Care, Decision-Making, Advance Lung Cancer, Stage III Lung Cancer, Stage IV Lung Cancer
- Keywords
- Cancer, Enhanced Care, Decision-Making, Advance Lung Cancer, Questionaires, Stage III Lung Cancer, Stage IV Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Virginia, National Institute of Nursing Research (NINR)
- Study start
- Nov 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Dec 2007 (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 purpose of this study is to evaluate a new program to help the patient and the caregiver make decisions about treatment for lung cancer. We need to know if a new information program is helpful to patients. The way that we will do this is by comparing it with the usual information program that we now provide.
Patient are asked to make difficult decisions about their treatments. These decisions may include when to change treatments or when to stop treatment altogether. Most patients ask a family member or close friend to help them with these difficult decisions. A "caregiver" is someone they can count on to give support (either emotional or physical) over a period of time. The doctors and nurses will also help patients and their caregiver to make these decisions.
They will tell them the risks with each treatment, the success with each treatment, and how much time there is for making each decision.
Detailed description
Many patients with advanced lung cancer and their caregivers struggle with treatment decisions, such as when to say "enough." Patient preparation for facing termination of cancer-directed therapy for the number one cause of cancer mortality for both men and women in the U.S. is not well handled in most clinical practices. Sparse literature validates that this concern is often denied by investigators. Failure to engage in a systematic, informed decision-making process, even in the initial stage of treatment, may often result in patients looking back and saying, "Knowing what I know now, I wouldn't make the same choice" The long-term goal of this program of research is to enhance patient care for lung cancer by oncology health professionals and to promote patient empowerment to make informed choices, defined as the ability to actively understand and influence one's health status. For this study, shared decision making is defined as a tailored, interactive process (emphasizing beliefs/personal values) in which the patient is informed enough to ask pertinent questions and to participate in the final decision at his/her own preference and comfort levels. The intent is to test a decision aid for patients with advanced lung cancer to help facilitate informed decisions about treatments that affect quality of life, including termination of cancer-directed treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Enhance CareEnhance Care (EC) will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits. |
| 2 | Other | Behavioral: Usual CareAs an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making. Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically or cytologically determined non-small cell lung cancer
- Stage IIIA, IIIB or IV extent
- No prior chemotherapy unless used in adjuvant therapy, completed more than two years ago, and no sign of any other malignancy active at this time
- Lung cancer-directed treatment with a standard or investigative chemotherapy regimen at entry
- Patients with brain metastasis are acceptable provided they are at least 3 weeks from completion of radiation therapy for brain metastasis, have stable and acceptable neurological status, and meet all other eligibility criteria. For patients undergoing gamma knife procedure, cognitive ability is the judgment call of the oncologist and study nurse as to whether comprehension is not a problem.
Key exclusion criteria (5 listed)
- Performance status of KPS 60-100% or ECOG 0-2;
- No age limit
- Life expectancy greater than three months
- A caregiver (any family member or concerned other who consistently provides emotional and/or physical support) available to also participate
- Patient and caregiver are able to understand English (ability to repeat back in their own words)
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 |
|---|---|---|
| Enhance CareAlso: ECEC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits | Behavioural | 1 |
| Usual CareAs an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making. Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic. | Behavioural | 2 |
Primary outcome
To determine the feasibility of implementing a short, clinic-based, decision-making aid (cognitive-behavioral skills intervention) for patients with advanced lung cancer (and their caregivers) facing cancer-directed treatment.
Time frame: 2 years
1 secondary outcome
To gather data for testing the hypothesis that patients with advanced lung cancer who receive a decision aid will report increased quality decision making, and decreased decisional conflict at the end of Decision 3 compared to the usual care group.
Time frame: 2 years
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 18 Mar 2009.
- Memorial Sloan-Kettering web siteLink 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.
Leslie B Tyson, NO principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhance Care in people with Cancer and Enhanced Care, run by Memorial Sloan Kettering Cancer Center at 2 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 5 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 18 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
To determine the feasibility of implementing a short, clinic-based, decision-making aid (cognitive-behavioral skills intervention) for patients with advanced lung cancer (and their caregivers) facing cancer-directed treatment. (time frame: 2 years). 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 18 Mar 2009.