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

Tracking Information

First Received Date ^ICMJE

January 5, 2011

Last Updated Date

January 6, 2011

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01272024 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Intervention to Improve Outcomes in Patients With Advanced Cancer

Official Title ^ICMJE

An Intervention to Improve Outcomes in Patients With Advanced Cancer

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Cancer

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

140

Estimated Completion Date

July 2012

Estimated Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Elizabeth Ercolano, RN, DNSc

203-737-2193

elizabeth.ercolano@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01272024

Other Study ID Numbers ^ICMJE

0909005722, R01NR011872

Has Data Monitoring Committee

Responsible Party

Dr. Ruth Mc Corkle, PI, Yale University School of Nursing

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Institute of Nursing Research (NINR)

Investigators ^ICMJE

Principal Investigator:

Ruth McCorkle, RN, PhD

Yale University

Information Provided By

Yale University

Verification Date

January 2011

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

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