An Intervention to Improve Outcomes in Patients With Advanced Cancer

Phase 3

Completed

• Conditions: Cancer
• Interventions: Behavioral: Symptom Education; Behavioral: Intervention

• Registration Number: NCT01272024
• Lead Sponsor: Yale University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-01-05
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-13
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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-

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Information/Education Group	Symptom Education	Assistance in using Symptom Management Toolkit
Nurse Intervention	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.

Primary Outcome Measures

Name	Time	Method
Uncertainty	3 months post-baseline	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

Name	Time	Method
HADS- Anxiety	1 month post baseline	7 items are rated on a 4-point scale.
HADS-Anxiety	3 months post baseline.	7 items are rated on a 4-point scale.

Trial Locations

Locations (1)

Yale New Haven Hospital/Smilow Cancer Hospital; 🇺🇸 New Haven, Connecticut, United States