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

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: 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.


Enrollment:	146
Study Start Date:	September 2009
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	January 5, 2011
Last Updated:	June 13, 2016
Health Authority:	United States: Federal Government

Keywords provided by Yale University:


clinical trial symptom education advanced cancer

ClinicalTrials.gov processed this record on September 30, 2016

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