An Intervention to Improve Outcomes in Patients With Advanced Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Uncertainty
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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-
Exclusion Criteria
- Not provided
Arms & Interventions
Information/Education Group
Assistance in using Symptom Management Toolkit
Intervention: Symptom Education (Behavioral)
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.
Intervention: Intervention (Behavioral)
Outcomes
Primary Outcomes
Uncertainty
Time Frame: 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.
Uncertainty
Time Frame: 1 month post baseline
The MUIS-C contains 23 Likert scale items with scores that range from 1= strongly disagree to 5= strongly agree.
Secondary Outcomes
- HADS- Anxiety(1 month post baseline)
- HADS-Anxiety(3 months post baseline.)