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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01272024
First received: January 5, 2011
Last updated: June 13, 2016
Last verified: June 2016

January 5, 2011
June 13, 2016
September 2009
August 2013   (final data collection date for primary outcome measure)
  • Uncertainty [ Time Frame: 1 month post baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ClinicalTrials.gov Archive Site
  • HADS- Anxiety [ Time Frame: 1 month post baseline ] [ Designated as safety issue: No ]
    7 items are rated on a 4-point scale.
  • HADS-Anxiety [ Time Frame: 3 months post baseline. ] [ Designated as safety issue: No ]
    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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cancer
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
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:

Both
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01272024
0909005722, R01NR011872
No
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