An Intervention to Improve Outcomes in Patients With Advanced Cancer (TEAMS)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||An Intervention to Improve Outcomes in Patients With Advanced Cancer|
- 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.
- 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.
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Information/Education Group
Assistance in using Symptom Management Toolkit
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272024
|Contact: Elizabeth Ercolano, RN, DNScfirstname.lastname@example.org|
|United States, Connecticut|
|Yale New Haven Hospital/Smilow Cancer Hospital||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator: Ruth McCorkle, RN, PhD|
|Principal Investigator:||Ruth McCorkle, RN, PhD||Yale University|