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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.
ClinicalTrials.gov Identifier: NCT01272024
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: Symptom Education Behavioral: Intervention Phase 3

Study Design

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
Primary Completion Date : August 2013
Study Completion Date : August 2013
Arms and Interventions

Arm Intervention/treatment
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. HADS- Anxiety [ Time Frame: 1 month post baseline ]
    7 items are rated on a 4-point scale.

  2. HADS-Anxiety [ Time Frame: 3 months post baseline. ]
    7 items are rated on a 4-point scale.


Eligibility Criteria

Information from the National Library of Medicine

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

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:

Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Connecticut
Yale New Haven Hospital/Smilow Cancer Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Ruth McCorkle, RN, PhD Yale University
More Information

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