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
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Behavioral: Symptom Education Behavioral: Intervention||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|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|
Active Comparator: Information/Education Group
Assistance in using Symptom Management Toolkit
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.
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.
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.
- 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.
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|