CancerPhase 3TEAMSNCT01272024
An Intervention to Improve Outcomes in Patients With Advanced Cancer
A Phase 3 study testing Symptom Education and Intervention in people with Cancer, run by Yale University at 1 site in United States.
Trial summary
1.) To integrate discharge planning into an intervention provided by advanced practice nurses (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the intervention, and 3.) To explore the reach, adoption, and implementation of the intervention to facilitate the transition of patients from… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Symptom Education and Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2013
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of advanced lung, GI, Head \& Neck, and Lung cancers
- post-surgical/or post-biopsy with physician's order for cancer treatment
- age 21 years or older
- lives within 50 of Yale New Haven Hospital
- has 2 or more co-morbid conditions
- has an emotional distress thermometer score of greater than or equal to 4-
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital/Smilow Cancer Hospital
New Haven, Connecticut, 06510
About this study
1.) To integrate discharge planning into an intervention provided by advanced practice nurses (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the intervention, and 3.) To explore the reach, adoption, and implementation of the intervention to facilitate the transition of patients from surgery/biopsy/chemotherapy to medical oncology in a comprehensive cancer center.
- Conditions
- Cancer
- Being tested
- Symptom Education, Intervention
- Keywords
- clinical trial, symptom education, advanced cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom EducationBehavioural
Participants are given a Symptom Education Toolkit at baseline and at each visit thereafter (1 month and 3 month) are encouraged to use the Toolkit for symptoms they are experiencing. They are also encouraged to use resources available to them.
InterventionBehavioural
Participants are visited/contacted by an intervention nurse ten times over a 12-week period for the purpose of helping them to manage uncertainty and distress,to boost their problem-solving skills, and to transition to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Information/Education Group | Active comparator | Assistance in using Symptom Management Toolkit Receives: Behavioral: Symptom Education |
| Nurse Intervention | Experimental | Participants are given intensive nurse contacts to reduce uncertainty and maximize problem solving, and later, to transition to the treatment phase of their cancer. Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncertainty
The MUIS-C contains 23 Likert scale items with scores that range from 1= strongly disagree to 5= strongly agree.
Measured: 1 month post baseline
Uncertainty
The MUIS-C is a 23-item scale that asks the respondent to rate items on a scale of 1=strongly disagree to 5= strongly agree.
Measured: 3 months post-baseline
Secondary outcomes (2)
HADS- Anxiety
7 items are rated on a 4-point scale.
Measured: 1 month post baseline
HADS-Anxiety
7 items are rated on a 4-point scale.
Measured: 3 months post baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completionAug 2013
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 Yale UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Ruth McCorkle, RN, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272024
- Sponsor's protocol ID
- 0909005722
- Other IDs
- R01NR011872
- Acronym
- TEAMS
- Status last verified
- Jun 2016
- First submitted
- 5 Jan 2011
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Improve Outcomes in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01272024
- Acronym / sponsor ID
- TEAMS / 0909005722
- Conditions
- Cancer
- Keywords
- clinical trial, symptom education, advanced cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 7 Jan 2011 (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.
1.) To integrate discharge planning into an intervention provided by advanced practice nurses (APRNs)for patients with advanced cancer, 2.) To evaluate the effects of the intervention, and 3.) To explore the reach, adoption, and implementation of the intervention to facilitate the transition of patients from surgery/biopsy/chemotherapy to medical oncology in a comprehensive cancer center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information/Education Group | Active comparator | Behavioral: Symptom EducationAssistance in using Symptom Management Toolkit |
| Nurse Intervention | Experimental | Behavioral: InterventionParticipants are given intensive nurse contacts to reduce uncertainty and maximize problem solving, and later, to transition to the treatment phase of their cancer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- primary diagnosis of advanced lung, GI, Head \& Neck, and Lung cancers
- post-surgical/or post-biopsy with physician's order for cancer treatment
- age 21 years or older
- lives within 50 of Yale New Haven Hospital
- has 2 or more co-morbid conditions
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 |
|---|---|---|
| Symptom EducationParticipants are given a Symptom Education Toolkit at baseline and at each visit thereafter (1 month and 3 month) are encouraged to use the Toolkit for symptoms they are experiencing. They are also encouraged to use resources available to them. | Behavioural | Information/Education Group |
| InterventionParticipants are visited/contacted by an intervention nurse ten times over a 12-week period for the purpose of helping them to manage uncertainty and distress,to boost their problem-solving skills, and to transition to treatment. | Behavioural | Nurse Intervention |
Primary outcome
Uncertainty
Time frame: 1 month post baseline
The MUIS-C contains 23 Likert scale items with scores that range from 1= strongly disagree to 5= strongly agree.
Uncertainty
Time frame: 3 months post-baseline
The MUIS-C is a 23-item scale that asks the respondent to rate items on a scale of 1=strongly disagree to 5= strongly agree.
2 secondary outcomes
HADS- Anxiety
Time frame: 1 month post baseline
HADS-Anxiety
Time frame: 3 months post baseline.
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 Jun 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.
Ruth McCorkle, RN, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Symptom Education and Intervention in people with Cancer, run by Yale University 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 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 15 Jun 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Uncertainty (time frame: 1 month post baseline). The study lists 2 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 15 Jun 2016.