An Intervention to Improve Outcomes in Patients With Advanced Cancer

Cancer Clinical Trial

— TEAMS  

Official title:

An Intervention to Improve Outcomes in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272024
• Other study ID #: 0909005722
• Secondary ID: R01NR011872
• Status: Completed
• Phase: Phase 3
• First received: January 5, 2011
• Last updated: June 13, 2016
• Start date: September 2009
• Est. completion date: August 2013

Study information

• Verified date: June 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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:

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital/Smilow Cancer Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncertainty	The MUIS-C contains 23 Likert scale items with scores that range from 1= strongly disagree to 5= strongly agree.	1 month post baseline	No
Primary	Uncertainty	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.	3 months post-baseline	No
Secondary	HADS- Anxiety	7 items are rated on a 4-point scale.	1 month post baseline	No
Secondary	HADS-Anxiety	7 items are rated on a 4-point scale.	3 months post baseline.	No