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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01272024
First received: January 5, 2011
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention Phase
Cancer
 Behavioral: Symptom Education
Behavioral: Intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Intervention to Improve Outcomes in Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 140
Study Start Date: September 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272024

Contacts
Contact: Elizabeth Ercolano, RN, DNSc 203-737-2193 elizabeth.ercolano@yale.edu

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

No publications provided

Responsible Party: Dr. Ruth Mc Corkle, PI, Yale University School of Nursing
ClinicalTrials.gov Identifier: NCT01272024     History of Changes
Other Study ID Numbers: 0909005722, R01NR011872
Study First Received: January 5, 2011
Last Updated: January 6, 2011
Health Authority: United States: Federal Government

Keywords provided by Yale University:
clinical trial
symptom education
advanced cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013