An Intervention to Improve Outcomes in Patients With Advanced Cancer

NCT01272024 | Completed Phase 3

• 2 other identifiers: 0909005722R01NR011872
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

clinical trial; symptom education; advanced cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• HADS- Anxiety

  1 month post baseline

• HADS-Anxiety

  3 months post baseline.

Study Arms (2)

Information/Education Group

ACTIVE COMPARATOR

Assistance in using Symptom Management Toolkit

Behavioral: Symptom Education

Nurse Intervention

EXPERIMENTAL

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

Interventions

Symptom Education BEHAVIORAL

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.

Information/Education Group

Intervention BEHAVIORAL

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.

Nurse Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

Sponsors & Collaborators

• Yale University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Yale New Haven Hospital/Smilow Cancer Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ruth McCorkle, RN, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 7, 2011
• Study Start: September 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

US (1)