An Intervention to Improve Outcomes in Patients With Advanced Cancer (TEAMS)
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ClinicalTrials.gov Identifier: NCT01272024 |
Recruitment Status
:
Completed
First Posted
: January 7, 2011
Last Update Posted
: June 15, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Behavioral: Symptom Education Behavioral: Intervention | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 146 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | An Intervention to Improve Outcomes in Patients With Advanced Cancer |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Information/Education Group
Assistance in using Symptom Management Toolkit
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Behavioral: Symptom Education
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.
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Experimental: Nurse Intervention
Participants are given intensive nurse contacts to reduce uncertainty and maximize problem solving, and later, to transition to the treatment phase of their cancer.
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Behavioral: Intervention
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.
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- 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.
- HADS- Anxiety [ Time Frame: 1 month post baseline ]7 items are rated on a 4-point scale.
- HADS-Anxiety [ Time Frame: 3 months post baseline. ]7 items are rated on a 4-point scale.

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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-
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272024
United States, Connecticut | |
Yale New Haven Hospital/Smilow Cancer Hospital | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Ruth McCorkle, RN, PhD | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01272024 History of Changes |
Other Study ID Numbers: |
0909005722 R01NR011872 ( U.S. NIH Grant/Contract ) |
First Posted: | January 7, 2011 Key Record Dates |
Last Update Posted: | June 15, 2016 |
Last Verified: | June 2016 |
Keywords provided by Yale University:
clinical trial symptom education advanced cancer |