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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01272024
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : June 15, 2016
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Yale University

January 5, 2011
January 7, 2011
June 15, 2016
September 2009
August 2013   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01272024 on Archive Site
  • 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.
Same as current
Not Provided
Not Provided
An Intervention to Improve Outcomes in Patients With Advanced Cancer
An Intervention to Improve Outcomes in Patients With Advanced Cancer
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • 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.
  • 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.
  • Active Comparator: Information/Education Group
    Assistance in using Symptom Management Toolkit
    Intervention: Behavioral: Symptom Education
  • 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.
    Intervention: Behavioral: Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2013
August 2013   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01NR011872 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Yale University
Yale University
National Institute of Nursing Research (NINR)
Principal Investigator: Ruth McCorkle, RN, PhD Yale University
Yale University
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP