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An Intervention to Improve Outcomes in Patients With Advanced Cancer

An Intervention to Improve Outcomes in Patients With Advanced Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01272024
Acronym
TEAMS
Enrollment
146
Registered
2011-01-07
Start date
2009-09-30
Completion date
2013-08-31
Last updated
2016-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

clinical trial, symptom education, 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.

Interventions

BEHAVIORALSymptom 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.

BEHAVIORALIntervention

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.

Sponsors

National Institute of Nursing Research (NINR)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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-

Design outcomes

Primary

MeasureTime frameDescription
Uncertainty1 month post baselineThe MUIS-C contains 23 Likert scale items with scores that range from 1= strongly disagree to 5= strongly agree.

Secondary

MeasureTime frameDescription
HADS- Anxiety1 month post baseline7 items are rated on a 4-point scale.
HADS-Anxiety3 months post baseline.7 items are rated on a 4-point scale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026