An Intervention to Improve Outcomes in Patients With Advanced Cancer (TEAMS)
|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.
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|